FDA 510(k)

UniPrime A, UniPrime E, UniPrime E/C

K-Number: K221033 · 2022-07-06

ApplicantS&C Polymer Silicon- Und Composite Spezialitäten GmbH

Decision Date2022-07-06

Product CodeKLE

Advisory CommitteeDE

DecisionSubstantially Equivalent

Device Summary

UniPrime A, UniPrime E, UniPrime E/C is a medical device manufactured by S&C Polymer Silicon- Und Composite Spezialitäten GmbH. It received FDA 510(k) clearance on 2022-07-06 under approval number K221033. The device is classified under product code KLE. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the UniPrime A, UniPrime E, UniPrime E/C?

UniPrime A, UniPrime E, UniPrime E/C is a medical device that received FDA 510(k) clearance on 2022-07-06. It is manufactured by S&C Polymer Silicon- Und Composite Spezialitäten GmbH. The 510(k) number is K221033.

When was UniPrime A, UniPrime E, UniPrime E/C approved by the FDA?

UniPrime A, UniPrime E, UniPrime E/C received FDA 510(k) clearance on 2022-07-06, under approval number K221033.

What company makes UniPrime A, UniPrime E, UniPrime E/C?

UniPrime A, UniPrime E, UniPrime E/C is manufactured by S&C Polymer Silicon- Und Composite Spezialitäten GmbH.

What is the FDA product code for UniPrime A, UniPrime E, UniPrime E/C?

The FDA product code for UniPrime A, UniPrime E, UniPrime E/C is KLE.

Related Devices (Code: KLE)

K161891HC PrimerShofu Dental Corporation K161042CLEARFIL Universal Bond Quick Bottle Standard Kit, CLEARFIL Universal Bond Quick Bottle Refill, CLEARFIL Universal Bond Quick Bottle Value packKuraray Noritake Dental, Inc. K161051All-Bond Universal w/BAC (not finalized)Bisco, Inc. K171226TOKUYAMA UNIVERSAL BONDTokuyama Dental Corporation K172176Parkell Universal AdhesiveParkell, Inc. K172106SHOFU MZ Primer PlusShofu Dental Corporation

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.