Establishments and listings

Temp Tabs Natural

DMG CHEMISCH PHARMAZEUTISCHE FABRIK GMBH · HAMBURG, DE

Manufacture Medical DeviceReg. 8044164EBG
K number
K033227
Proprietary name
Temp Tabs Natural
Establishment type
Manufacture Medical Device
Registration
Registration number
8044164
FEI number
3004150030
Status code
1
Initial importer flag
N
Reg expiry date year
2026
Name
DMG CHEMISCH PHARMAZEUTISCHE FABRIK GMBH
Address line 1
ELBGAUSTRASSE 248
City
HAMBURG
Iso country code
DE
Postal code
D-22547
US agent
Name
Pamela Papineau
Business name
Delphi Medical Device Consulting, Inc.
Bus phone area code
978
Bus phone num
7588322
Email address
delphimdc@comcast.net
Address line 1
5 WHITCOMB AVENUE
City
Ayer
State code
MA
Iso country code
US
Zip code
01432
Owner operator
Firm name
DMG CHEMISCH PHARMAZEUTISCHE FABRIK GMBH
Owner operator number
9005969
Contact address
Address 1
ELBGAUSTRASSE 248
Address 2
--
City
HAMBURG
State code
DE-HH
Iso country code
DE
Postal code
D-22547
Products
  1. Product code
    EBG
    Created date
    2011-10-26
    Owner operator number
    9005969
    Harmonized identifiers (openFDA)
    Device name
    Crown And Bridge, Temporary, Resin
    Medical specialty description
    Dental
    Regulation number
    872.3770
    Device class
    2
Establishments and listings

PermaCem Smartmix Dual USA

DMG CHEMISCH PHARMAZEUTISCHE FABRIK GMBH · HAMBURG, DE

Manufacture Medical DeviceReg. 8044164EMA
K number
K982895
Proprietary name
PermaCem Smartmix Dual USA
Establishment type
Manufacture Medical Device
Registration
Registration number
8044164
FEI number
3004150030
Status code
1
Initial importer flag
N
Reg expiry date year
2026
Name
DMG CHEMISCH PHARMAZEUTISCHE FABRIK GMBH
Address line 1
ELBGAUSTRASSE 248
City
HAMBURG
Iso country code
DE
Postal code
D-22547
US agent
Name
Pamela Papineau
Business name
Delphi Medical Device Consulting, Inc.
Bus phone area code
978
Bus phone num
7588322
Email address
delphimdc@comcast.net
Address line 1
5 WHITCOMB AVENUE
City
Ayer
State code
MA
Iso country code
US
Zip code
01432
Owner operator
Firm name
DMG CHEMISCH PHARMAZEUTISCHE FABRIK GMBH
Owner operator number
9005969
Contact address
Address 1
ELBGAUSTRASSE 248
Address 2
--
City
HAMBURG
State code
DE-HH
Iso country code
DE
Postal code
D-22547
Products
  1. Product code
    EMA
    Created date
    2007-12-18
    Owner operator number
    9005969
    Harmonized identifiers (openFDA)
    Device name
    Cement, Dental
    Medical specialty description
    Dental
    Regulation number
    872.3275
    Device class
    2
Establishments and listings

Silagum AM Comfort Primer Refi, Silagum Comfort 1x50ml + 12 +1

DMG CHEMISCH PHARMAZEUTISCHE FABRIK GMBH · HAMBURG, DE

Manufacture Medical DeviceReg. 8044164EBI
K number
K992609
Proprietary name
Silagum AM Comfort Primer Refi, Silagum Comfort 1x50ml + 12, Silagum AM Comfort Varnish Ref
Establishment type
Manufacture Medical Device
Registration
Registration number
8044164
FEI number
3004150030
Status code
1
Initial importer flag
N
Reg expiry date year
2026
Name
DMG CHEMISCH PHARMAZEUTISCHE FABRIK GMBH
Address line 1
ELBGAUSTRASSE 248
City
HAMBURG
Iso country code
DE
Postal code
D-22547
US agent
Name
Pamela Papineau
Business name
Delphi Medical Device Consulting, Inc.
Bus phone area code
978
Bus phone num
7588322
Email address
delphimdc@comcast.net
Address line 1
5 WHITCOMB AVENUE
City
Ayer
State code
MA
Iso country code
US
Zip code
01432
Owner operator
Firm name
DMG CHEMISCH PHARMAZEUTISCHE FABRIK GMBH
Owner operator number
9005969
Contact address
Address 1
ELBGAUSTRASSE 248
Address 2
--
City
HAMBURG
State code
DE-HH
Iso country code
DE
Postal code
D-22547
Products
  1. Product code
    EBI
    Created date
    2014-03-07
    Owner operator number
    9005969
    Harmonized identifiers (openFDA)
    Device name
    Resin, Denture, Relining, Repairing, Rebasing
    Medical specialty description
    Dental
    Regulation number
    872.3760
    Device class
    2
Establishments and listings

Flairesse Bleaching Gel CP 10% Refill, Flairesse Bleaching Gel CP 16% Refill +4

DMG CHEMISCH PHARMAZEUTISCHE FABRIK GMBH · HAMBURG, DE

Manufacture Medical DeviceReg. 8044164MAU
Proprietary name
Flairesse Bleaching Gel CP 10% Refill, Flairesse Bleaching Gel CP 16% Refill, Flairesse Bleaching Gel CP 5% Refill, Flairesse Bleaching Gel CP 16% Starter Kit, Flairesse Bleaching Gel CP 10% Starter Kit, Flairesse Bleaching Gel CP 5% Starter Kit
Establishment type
Manufacture Medical Device
Registration
Registration number
8044164
FEI number
3004150030
Status code
1
Initial importer flag
N
Reg expiry date year
2026
Name
DMG CHEMISCH PHARMAZEUTISCHE FABRIK GMBH
Address line 1
ELBGAUSTRASSE 248
City
HAMBURG
Iso country code
DE
Postal code
D-22547
US agent
Name
Pamela Papineau
Business name
Delphi Medical Device Consulting, Inc.
Bus phone area code
978
Bus phone num
7588322
Email address
delphimdc@comcast.net
Address line 1
5 WHITCOMB AVENUE
City
Ayer
State code
MA
Iso country code
US
Zip code
01432
Owner operator
Firm name
DMG CHEMISCH PHARMAZEUTISCHE FABRIK GMBH
Owner operator number
9005969
Contact address
Address 1
ELBGAUSTRASSE 248
Address 2
--
City
HAMBURG
State code
DE-HH
Iso country code
DE
Postal code
D-22547
Products
  1. Product code
    MAU
    Created date
    2026-08-31
    Owner operator number
    9005969
    Harmonized identifiers (openFDA)
    Device name
    Eraser, Dental Stain
    Medical specialty description
    Dental
    Regulation number
    872.6855
    Device class
    1
Establishments and listings

LuxaBond Total Etch USA, TECO Introkit SilvR dose +5

DMG CHEMISCH PHARMAZEUTISCHE FABRIK GMBH · HAMBURG, DE

Manufacture Medical DeviceReg. 8044164KLE
K number
K131248
Proprietary name
LuxaBond Total Etch USA, TECO Introkit SilvR dose, Vitique Veneer Accessory Kit, DMG Etching Gel Jumbo, Vitique Veneer System, DMG Etching Gel Medium Viscosi, TECO Introkit SilvR dose USA
Establishment type
Manufacture Medical Device
Registration
Registration number
8044164
FEI number
3004150030
Status code
1
Initial importer flag
N
Reg expiry date year
2026
Name
DMG CHEMISCH PHARMAZEUTISCHE FABRIK GMBH
Address line 1
ELBGAUSTRASSE 248
City
HAMBURG
Iso country code
DE
Postal code
D-22547
US agent
Name
Pamela Papineau
Business name
Delphi Medical Device Consulting, Inc.
Bus phone area code
978
Bus phone num
7588322
Email address
delphimdc@comcast.net
Address line 1
5 WHITCOMB AVENUE
City
Ayer
State code
MA
Iso country code
US
Zip code
01432
Owner operator
Firm name
DMG CHEMISCH PHARMAZEUTISCHE FABRIK GMBH
Owner operator number
9005969
Contact address
Address 1
ELBGAUSTRASSE 248
Address 2
--
City
HAMBURG
State code
DE-HH
Iso country code
DE
Postal code
D-22547
Products
  1. Product code
    KLE
    Created date
    2015-06-17
    Owner operator number
    9005969
    Harmonized identifiers (openFDA)
    Device name
    Agent, Tooth Bonding, Resin
    Medical specialty description
    Dental
    Regulation number
    872.3200
    Device class
    2
Establishments and listings

Tray Adhesive 1x 10ml USA

DMG CHEMISCH PHARMAZEUTISCHE FABRIK GMBH · HAMBURG, DE

Manufacture Medical DeviceReg. 8044164EBH
Proprietary name
Tray Adhesive 1x 10ml USA
Establishment type
Manufacture Medical Device
Registration
Registration number
8044164
FEI number
3004150030
Status code
1
Initial importer flag
N
Reg expiry date year
2026
Name
DMG CHEMISCH PHARMAZEUTISCHE FABRIK GMBH
Address line 1
ELBGAUSTRASSE 248
City
HAMBURG
Iso country code
DE
Postal code
D-22547
US agent
Name
Pamela Papineau
Business name
Delphi Medical Device Consulting, Inc.
Bus phone area code
978
Bus phone num
7588322
Email address
delphimdc@comcast.net
Address line 1
5 WHITCOMB AVENUE
City
Ayer
State code
MA
Iso country code
US
Zip code
01432
Owner operator
Firm name
DMG CHEMISCH PHARMAZEUTISCHE FABRIK GMBH
Owner operator number
9005969
Contact address
Address 1
ELBGAUSTRASSE 248
Address 2
--
City
HAMBURG
State code
DE-HH
Iso country code
DE
Postal code
D-22547
Products
  1. Product code
    EBH
    Created date
    2007-12-18
    Owner operator number
    9005969
    Harmonized identifiers (openFDA)
    Device name
    Material, Impression Tray, Resin
    Medical specialty description
    Dental
    Regulation number
    872.3670
    Device class
    1
Establishments and listings

Vitique Try In White, Contax Intro + Activator +39

DMG CHEMISCH PHARMAZEUTISCHE FABRIK GMBH · HAMBURG, DE

Manufacture Medical DeviceReg. 8044164EMA
K number
K023649
Proprietary name
Vitique Try In White, Contax Intro + Activator, Vitique Try In A2,5, Vitique Try In White USA, Vitique Veneer System, Contax Intro + Activator USA, Silane 2-Komponenten USA, Vitique Try In B1, Vitique Cement A4, Vitique Try In A1, Contax-Primer Refill, Vitique Cement Transparent, Vitique Cement A1, Vitique Cement Pink, Vitique Basis White, Contax-Primer Refill USA, Vitique Intro Kit USA, Vitique Silane 2-Komponenten, Vitique Cement A2,5, Vitique Veneer Cementation Kit, Vitique Basis A4, Vitique Cement BL, Vitique Starter Kit, Vitique Cement White, Vitique Cement B1, Vitique Veneer Accessory Kit, Contax-Bond Refill, Vitique Catalyst High Viscosity, Vitique Basis A2,5, Vitique Basis B1, Vitique Try In Pink, Vitique Try In A4, Vitique Try In Catalyst Shade, Vitique Try In BL, Vitique Basis A1, Vitique Catalyst Low Viscosity, Vitique Try In Transparent, Vitique Basis BL, Vitique Basis Transparent, Contax-Activator Refill +1 more
Establishment type
Manufacture Medical Device
Registration
Registration number
8044164
FEI number
3004150030
Status code
1
Initial importer flag
N
Reg expiry date year
2026
Name
DMG CHEMISCH PHARMAZEUTISCHE FABRIK GMBH
Address line 1
ELBGAUSTRASSE 248
City
HAMBURG
Iso country code
DE
Postal code
D-22547
US agent
Name
Pamela Papineau
Business name
Delphi Medical Device Consulting, Inc.
Bus phone area code
978
Bus phone num
7588322
Email address
delphimdc@comcast.net
Address line 1
5 WHITCOMB AVENUE
City
Ayer
State code
MA
Iso country code
US
Zip code
01432
Owner operator
Firm name
DMG CHEMISCH PHARMAZEUTISCHE FABRIK GMBH
Owner operator number
9005969
Contact address
Address 1
ELBGAUSTRASSE 248
Address 2
--
City
HAMBURG
State code
DE-HH
Iso country code
DE
Postal code
D-22547
Products
  1. Product code
    EMA
    Created date
    2007-12-17
    Owner operator number
    9005969
    Harmonized identifiers (openFDA)
    Device name
    Cement, Dental
    Medical specialty description
    Dental
    Regulation number
    872.3275
    Device class
    2
Establishments and listings

TempoCem-Smartmix USA, TempoCem AM Refill 1+40 USA

DMG CHEMISCH PHARMAZEUTISCHE FABRIK GMBH · HAMBURG, DE

Manufacture Medical DeviceReg. 8044164EMB
K number
K110759
Proprietary name
TempoCem-Smartmix USA, TempoCem AM Refill 1+40 USA
Establishment type
Manufacture Medical Device
Registration
Registration number
8044164
FEI number
3004150030
Status code
1
Initial importer flag
N
Reg expiry date year
2026
Name
DMG CHEMISCH PHARMAZEUTISCHE FABRIK GMBH
Address line 1
ELBGAUSTRASSE 248
City
HAMBURG
Iso country code
DE
Postal code
D-22547
US agent
Name
Pamela Papineau
Business name
Delphi Medical Device Consulting, Inc.
Bus phone area code
978
Bus phone num
7588322
Email address
delphimdc@comcast.net
Address line 1
5 WHITCOMB AVENUE
City
Ayer
State code
MA
Iso country code
US
Zip code
01432
Owner operator
Firm name
DMG CHEMISCH PHARMAZEUTISCHE FABRIK GMBH
Owner operator number
9005969
Contact address
Address 1
ELBGAUSTRASSE 248
Address 2
--
City
HAMBURG
State code
DE-HH
Iso country code
DE
Postal code
D-22547
Products
  1. Product code
    EMB
    Created date
    2011-06-29
    Owner operator number
    9005969
    Harmonized identifiers (openFDA)
    Device name
    Zinc Oxide Eugenol
    Medical specialty description
    Dental
    Regulation number
    872.3275
    Device class
    1
Establishments and listings

Ionosit Microspand 10x 0,3g, Ionosit Baseliner 10x 0.3g USA +5

DMG CHEMISCH PHARMAZEUTISCHE FABRIK GMBH · HAMBURG, DE

Manufacture Medical DeviceReg. 8044164EBD
K number
K935689
Proprietary name
Ionosit Microspand 10x 0,3g, Ionosit Baseliner 10x 0.3g USA, Sample Baseliner 1x 0.3g USA, Ionosit Baseliner 2x 1.5g USA, Kit LX-Ultra A2+Ionosit BL, Kit LX-Plus A2+Ionosit BL, Ionosit Microspand 1x 0,3g
Establishment type
Manufacture Medical Device
Registration
Registration number
8044164
FEI number
3004150030
Status code
1
Initial importer flag
N
Reg expiry date year
2026
Name
DMG CHEMISCH PHARMAZEUTISCHE FABRIK GMBH
Address line 1
ELBGAUSTRASSE 248
City
HAMBURG
Iso country code
DE
Postal code
D-22547
US agent
Name
Pamela Papineau
Business name
Delphi Medical Device Consulting, Inc.
Bus phone area code
978
Bus phone num
7588322
Email address
delphimdc@comcast.net
Address line 1
5 WHITCOMB AVENUE
City
Ayer
State code
MA
Iso country code
US
Zip code
01432
Owner operator
Firm name
DMG CHEMISCH PHARMAZEUTISCHE FABRIK GMBH
Owner operator number
9005969
Contact address
Address 1
ELBGAUSTRASSE 248
Address 2
--
City
HAMBURG
State code
DE-HH
Iso country code
DE
Postal code
D-22547
Products
  1. Product code
    EBD
    Created date
    2007-12-17
    Owner operator number
    9005969
    Harmonized identifiers (openFDA)
    Device name
    Coating, Filling Material, Resin
    Medical specialty description
    Dental
    Regulation number
    872.3310
    Device class
    2
Establishments and listings

Luxaflow A20 Refill, Luxaflow Fluores. E-Light Ref. +9

DMG CHEMISCH PHARMAZEUTISCHE FABRIK GMBH · HAMBURG, DE

Manufacture Medical DeviceReg. 8044164EBF
K number
K011211
Proprietary name
Luxaflow A20 Refill, Luxaflow Fluores. E-Light Ref., Luxaflow Refill A10 USA, Luxaflow Fluores. A10 Refill, Luxaflow Floures. Intro USA, Luxaflow Fluores. A35 Refill, Luxaflow Refill B1 Extra Light, Luxaflow Refill A35, Luxaflow Fluores. A20 Refill, Luxaflow Fluores. A3 Refill US, LuxaFlow Ultra BL
Establishment type
Manufacture Medical Device
Registration
Registration number
8044164
FEI number
3004150030
Status code
1
Initial importer flag
N
Reg expiry date year
2026
Name
DMG CHEMISCH PHARMAZEUTISCHE FABRIK GMBH
Address line 1
ELBGAUSTRASSE 248
City
HAMBURG
Iso country code
DE
Postal code
D-22547
US agent
Name
Pamela Papineau
Business name
Delphi Medical Device Consulting, Inc.
Bus phone area code
978
Bus phone num
7588322
Email address
delphimdc@comcast.net
Address line 1
5 WHITCOMB AVENUE
City
Ayer
State code
MA
Iso country code
US
Zip code
01432
Owner operator
Firm name
DMG CHEMISCH PHARMAZEUTISCHE FABRIK GMBH
Owner operator number
9005969
Contact address
Address 1
ELBGAUSTRASSE 248
Address 2
--
City
HAMBURG
State code
DE-HH
Iso country code
DE
Postal code
D-22547
Products
  1. Product code
    EBF
    Created date
    2007-12-17
    Owner operator number
    9005969
    Harmonized identifiers (openFDA)
    Device name
    Material, Tooth Shade, Resin
    Medical specialty description
    Dental
    Regulation number
    872.3690
    Device class
    2

39 records share this identifier (an establishment lists each device separately); the first 10 are shown.

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Data from openFDA, FDA's public API. FDA says not to rely on it to make decisions about medical care and to treat every result as unvalidated; confirm against FDA's own record and the product labeling. Not medical or legal advice.