Ceram-Prime
FDA 510(k) K002502 · S & C Polymer GmbH
510(k) numberK002502
Submission
- Device name
- Ceram-Prime
- Applicant
- S & C Polymer GmbH
Elmshorn, DE - Received
- August 14, 2000
- Decision date
- November 8, 2000
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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| K252450 | Adhese 2KLE · Traditional | Ivoclar Vivadent, Inc. | 03/05/2026SE |
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| 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 |
|---|---|---|
| K091735 | DC Provi Cem Esthetic, Esthetic Multi F, ImplantEMA · Traditional | 09/25/2009SE |
| K083062 | Root Canal XRKIF · Traditional | 03/12/2009SE |
| K083766 | Phoglass CemEMA · Traditional | 03/02/2009SE |
| K082115 | Phoglass Fill, Core, Cem, Seal, Prime and Phoglass ProtectEMA · Traditional | 01/15/2009SE |
| K081702 | Carboxylate Cem, Phosphate CemEMA · Traditional | 09/05/2008SE |
| K042614 | S&C-Self Etch Pr-BondKLE · Traditional | 11/22/2004SE |
| K031420 | S & C -Bracket AdhesivesDYH · Traditional | 08/20/2003SE |
| K012767 | S & C Hydro Vinyl Polysiloxane Impression MaterialELW · Traditional | 11/01/2001SE |
| K011277 | Hard RelinerEBI · Traditional | 06/26/2001SE |
| K011431 | Resin CemEMA · Traditional | 06/11/2001SE |
Questions and answers
When was Ceram-Prime cleared by the FDA?
Ceram-Prime (K002502) received a 510(k) decision of Substantially Equivalent on November 8, 2000, 86 days after the submission was received.
What is the product code of K002502?
The FDA product code is KLE – Agent, Tooth Bonding, Resin, a Class II (moderate risk) device regulated under 21 CFR 872.3200.