510(k) clearances

Straumann InLab Validated Workflow

Institut Straumann AG · Dental

K243478Substantially EquivalentTraditionalNHA
Open FDA's page for this record
Third party flag
N
City
Basal
Advisory committee description
Dental
Address 1
Peter Merian-Weg 12
Statement or summary
Summary
Product code
NHA
Zip code
4002
Applicant
Institut Straumann AG
Decision date
2025-02-19
Decision code
SESE
Country code
CH
Device name
Straumann InLab Validated Workflow
Advisory committee
DE
Contact
Olivier Russo
K number
K243478
Date received
2024-11-08
Review advisory committee
DE
Postal code
4002
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.