Phoglass Cem
FDA 510(k) K083766 · S & C Polymer GmbH
510(k) numberK083766
Submission
- Device name
- Phoglass Cem
- Applicant
- S & C Polymer GmbH
Elmshorn, DE - Received
- December 18, 2008
- Decision date
- March 2, 2009
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Other 510(k)s with product code EMA
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K254201 | Any-CemEMA · Traditional | Mediclus Co., Ltd. | 08/13/2026SE |
| K261937 | PacTemp Automix NEEMA · Traditional | The Belport Company Inc., DBA Gingi-Pak | 08/07/2026SE |
| K261166 | Dia-CemEMA · Traditional | DiaDent Group International | 07/09/2026SE |
| K254109 | G-Cem UniversalEMA · Traditional | GC America, Inc. | 05/18/2026SE |
| K253337 | REGEN Bioactive CementEMA · Traditional | Inter-Med, Inc. | 04/15/2026SE |
| K252606 | Bifix Veneer LC, Bifix Veneer Try-InEMA · Traditional | Voco GmbH | 03/20/2026SE |
| K254063 | iCEM Universal PlusEMA · Abbreviated | Kulzer, LLC | 12/19/2025SE |
| K252785 | TopCEM Vigor SA Self-Adhesive Resin CementEMA · Traditional | Rizhao Huge Biomaterials Company, Ltd. | 12/12/2025SE |
| K252808 | GlasIonomer FX-LCEMA · Traditional | Shofu Dental Corporation | 12/09/2025SE |
| K252165 | Zirconomer PEMA · Traditional | Shofu Dental Corporation | 10/28/2025SE |
More from Shofu Dental Corporation
| 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 |
| 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 |
| K011064 | Classic CemEMA · Traditional | 05/17/2001SE |
Questions and answers
When was Phoglass Cem cleared by the FDA?
Phoglass Cem (K083766) received a 510(k) decision of Substantially Equivalent on March 2, 2009, 74 days after the submission was received.
What is the product code of K083766?
The FDA product code is EMA – Cement, Dental, a Class II (moderate risk) device regulated under 21 CFR 872.3275.