UniPrime A, UniPrime E, UniPrime E/C

FDA 510(k) K221033 · S&C Polymer Silicon- Und Composite Spezialitäten GmbH

Substantially Equivalent

510(k) numberK221033

Submission

Device name
UniPrime A, UniPrime E, UniPrime E/C
Applicant
S&C Polymer Silicon- Und Composite Spezialitäten GmbH
Elmshorn, DE
Received
April 7, 2022
Decision date
July 6, 2022
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
KLE – Agent, Tooth Bonding, Resin
Device class
Class II (moderate risk)
Regulation
21 CFR 872.3200
Specialty
Dental

Other 510(k)s with product code KLE

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K260485Any-EtchKLE · Traditional Mediclus Co., Ltd.05/14/2026SE
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K252450Adhese 2KLE · Traditional Ivoclar Vivadent, Inc.03/05/2026SE
K260682Bond-PR™ Universal AdhesiveKLE · Traditional Premier Dental Products Company03/03/2026SE
K251587VITA VMLC PrimerKLE · Traditional Vita Zahnfabrik H. Rauter GmbH & Co. Kg.02/23/2026SE
K252151els unibondKLE · Traditional Saremco Dental AG12/05/2025SE
K252469Magnabond Se; Magnabond Universal; Magnabond Universal DcaKLE · Traditional Dmp Dental Industry S.A.11/06/2025SE
K251124G-Bond UniversalKLE · Traditional GC America, Inc.10/02/2025SE
K242530HF-Etchant Hydrofluoric Acid Etching GelKLE · Traditional Rizhao Huge Biomaterials Company, Ltd.12/20/2024SE
K242749TopCEM Ceramic Primer Ceramic Coupling AgentKLE · Traditional Rizhao Huge Biomaterials Company, Ltd.11/08/2024SE

Questions and answers

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

UniPrime A, UniPrime E, UniPrime E/C (K221033) received a 510(k) decision of Substantially Equivalent on July 6, 2022, 90 days after the submission was received.

What is the product code of K221033?

The FDA product code is KLE – Agent, Tooth Bonding, Resin, a Class II (moderate risk) device regulated under 21 CFR 872.3200.