510(k) clearances

DESS Dental Smart Solutions

Terrats Medical SL · Dental

K243212Substantially EquivalentTraditionalNHA
Open FDA's page for this record
Third party flag
N
City
Barcelona
Advisory committee description
Dental
Address 1
Mogoda, 75
Address 2
Barbera Del Valles
Statement or summary
Summary
Product code
NHA
Zip code
08210
Applicant
Terrats Medical SL
Decision date
2025-02-14
Decision code
SESE
Country code
ES
Device name
DESS Dental Smart Solutions
Advisory committee
DE
Contact
Roger Terrats
K number
K243212
Date received
2024-10-02
Review advisory committee
DE
Postal code
08210
Decision description
Substantially Equivalent
Clearance type
Traditional
Harmonized identifiers (openFDA)
Device name
Abutment, Implant, Dental, Endosseous
Medical specialty description
Dental
Regulation number
872.3630
Device class
2
Registration number
1226544, 3023265483, 9613866, 3006973441, 3007362683, 3005730680, 3011587630, 1038806, 1424785, 3012635238, 3010860907, 2244842, 9613283, 3005031178, 3007283751, 3011808221, 3023535580, 3012187973, 3036779616, 3004417597, 3031162123, 8031058, 3030690317, 3009756327, 3007597023, 1036836, 3008088588, 3007135442, 3009727738, 3018077122, 3005554774, 3003402534, 3013465593, 2133778, 2530808, 3005503242, 3011649314, 3010303805, 3017450159, 3009514134 +342 more
FEI number
3023265483, 3006973441, 3007362683, 3005730680, 3011587630, 1038806, 3012635238, 3010860907, 2244842, 3005031178, 3007283751, 3011808221, 3023535580, 3012187973, 3036779616, 3004417597, 3031162123, 3030690317, 3007597023, 1036836, 3008088588, 3007135442, 3009727738, 3018077122, 3005554774, 3002768455, 3003402534, 3013465593, 3005503242, 1000272060, 3011649314, 3010303805, 3017450159, 3009514134, 3003394627, 3005597557, 3012205930, 3039641923, 3003024548, 3002807050 +342 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.