510(k) clearances

dima Print Teeth & Temp

Kulzer, LLC · Dental

K233868Substantially EquivalentTraditionalEBG
Open FDA's page for this record
Third party flag
N
City
South Bend
Advisory committee description
Dental
Address 1
4315 S Lafayette Blvd.
Statement or summary
Summary
Product code
EBG
Zip code
46614
Applicant
Kulzer, LLC
Decision date
2024-05-23
Decision code
SESE
Country code
US
Device name
dima Print Teeth & Temp
Advisory committee
DE
Contact
David Vincent
K number
K233868
State
IN
Date received
2023-12-06
Review advisory committee
DE
Postal code
46614
Decision description
Substantially Equivalent
Clearance type
Traditional
Harmonized identifiers (openFDA)
Device name
Crown And Bridge, Temporary, Resin
Medical specialty description
Dental
Regulation number
872.3770
Device class
2
Registration number
3005665377, 3030515618, 3005628474, 3005350578, 3003231822, 8030452, 1410097, 1413475, 3023346365, 2437780, 3026312357, 3011824442, 1036212, 1937100, 3009409473, 3017374693, 8010711, 3032312561, 2027375, 3011944170, 2280629, 3011814610, 3008912871, 1221541, 2023129, 3002808149, 1450653, 3010664129, 2433919, 3011511773, 3014888923, 3024185724, 3010864832, 3004491043, 3043226252, 3006694515, 3022068322, 3009482106, 2411797, 1417322 +145 more
FEI number
3005665377, 3030515618, 3005628474, 3005350578, 3003231822, 1410097, 1413475, 3023346365, 3026312357, 3011824442, 1036212, 1937100, 3009409473, 3017374693, 3032312561, 2027375, 3011944170, 3002806930, 3002806620, 3011814610, 3008912871, 3003943714, 1221541, 3003667632, 2023129, 3002808149, 1450653, 3010664129, 2433919, 3011511773, 3014888923, 3024185724, 3003999430, 3004491043, 3043226252, 3006694515, 3022068322, 3009482106, 2411797, 1417322 +145 more
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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.