UniPrime A, UniPrime E, UniPrime E/C

Agent, Tooth Bonding, Resin

S&C Polymer Silicon- Und Composite Spezialitäten GmbH

The following data is part of a premarket notification filed by S&c Polymer Silicon- Und Composite Spezialitäten Gmbh with the FDA for Uniprime A, Uniprime E, Uniprime E/c.

Pre-market Notification Details

Device IDK221033
510k NumberK221033
Device Name:UniPrime A, UniPrime E, UniPrime E/C
ClassificationAgent, Tooth Bonding, Resin
Applicant S&C Polymer Silicon- Und Composite Spezialitäten GmbH Robert-Bosch-Str. 2 Elmshorn,  DE 25335
ContactChristian Böttcher
CorrespondentChristian Böttcher
S&C Polymer Silicon- Und Composite Spezialitäten GmbH Robert-Bosch-Str. 2 Elmshorn,  DE 25335
Product CodeKLE  
CFR Regulation Number872.3200 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2022-04-07
Decision Date2022-07-06

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
D745701198PVC00040 K221033 000
D745701198PVC00020 K221033 000

© 2022 FDA.report
This site is not affiliated with or endorsed by the FDA.