Premier Ceramic Primer
FDA 510(k) K131212 · Premier Dental Products Co.
510(k) numberK131212
Submission
- Device name
- Premier Ceramic Primer
- Applicant
- Premier Dental Products Co.
Plymouth Meeting, PA, US - Received
- April 29, 2013
- Decision date
- August 26, 2013
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
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| K260485 | Any-EtchKLE · Traditional | Mediclus Co., Ltd. | 05/14/2026SE |
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| K252450 | Adhese 2KLE · Traditional | Ivoclar Vivadent, Inc. | 03/05/2026SE |
| K260682 | Bond-PR Universal AdhesiveKLE · Traditional | Premier Dental Products Company | 03/03/2026SE |
| K251587 | VITA VMLC PrimerKLE · Traditional | Vita Zahnfabrik H. Rauter GmbH & Co. Kg. | 02/23/2026SE |
| K252151 | els unibondKLE · Traditional | Saremco Dental AG | 12/05/2025SE |
| K252469 | Magnabond Se; Magnabond Universal; Magnabond Universal DcaKLE · Traditional | Dmp Dental Industry S.A. | 11/06/2025SE |
| K251124 | G-Bond UniversalKLE · Traditional | GC America, Inc. | 10/02/2025SE |
| K242530 | HF-Etchant Hydrofluoric Acid Etching GelKLE · Traditional | Rizhao Huge Biomaterials Company, Ltd. | 12/20/2024SE |
| K242749 | TopCEM Ceramic Primer Ceramic Coupling AgentKLE · Traditional | Rizhao Huge Biomaterials Company, Ltd. | 11/08/2024SE |
More from Rizhao Huge Biomaterials Company, Ltd.
| 510(k) | Device | Decision |
|---|---|---|
| K260682 | Bond-PR Universal AdhesiveKLE · Traditional | 03/03/2026SE |
| K253513 | MultiMatch Flow Chameleon AntiMicrobial CompositeEBF · Traditional | 11/07/2025SE |
| K223632 | Premier's MultiMatch Universal Chameleon Restorative CompositeEBF · Traditional | 12/06/2022SE |
| K141839 | Premier EtchKLE · Traditional | 11/17/2014SE |
| K132526 | Knit-Pak+MVL · Traditional | 11/26/2013SE |
| K083695 | TraxodentMVL · Traditional | 04/28/2009SE |
| K062683 | Enamel Pro VarnishLBH · Traditional | 11/21/2006SE |
| K062166 | Enamel ProEJR · Traditional | 11/21/2006SE |
| K061998 | Premier Self-Etching Bond EnhancerKLE · Traditional | 10/04/2006SE |
| K061997 | Premier Self-Etching Enamel SealantEBC · Traditional | 10/04/2006SE |
Questions and answers
When was Premier Ceramic Primer cleared by the FDA?
Premier Ceramic Primer (K131212) received a 510(k) decision of Substantially Equivalent on August 26, 2013, 119 days after the submission was received.
What is the product code of K131212?
The FDA product code is KLE – Agent, Tooth Bonding, Resin, a Class II (moderate risk) device regulated under 21 CFR 872.3200.