Cemper
FDA 510(k) K904024 · Scientific Pharmaceuticals, Inc.
510(k) numberK904024
Submission
- Device name
- Cemper
- Applicant
- Scientific Pharmaceuticals, Inc.
Duarte, CA, US - Received
- August 30, 1990
- Decision date
- November 9, 1990
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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 |
|---|---|---|
| K192381 | DFV Desensitizing Varnish-Strawberry Flavor, DFV Desensitizing Varnish-Bubblegum…LBH · Traditional | 02/18/2020SE |
| K051952 | EugenoneEMA · Traditional | 09/07/2005SE |
| K041886 | ProvisoEBG · Traditional | 08/04/2004SE |
| K013555 | Sci-Pharm Post SecureEMA · Traditional | 01/23/2002SE |
| K001446 | Light-Cured Orthodontic Band CementDYH · Traditional | 07/21/2000SE |
| K993324 | Carbocem Zinc Polycarboxylate CementEMA · Traditional | 11/09/1999SE |
| K982915 | Sci-Pharm DFV VarnishLBH · Traditional | 02/12/1999SE |
| K983305 | Sci-Pharm Desensitizing VarnishLBH · Traditional | 12/17/1998SE |
| K982913 | Zinfos Zinc Phosphate CementEMA · Traditional | 10/19/1998SE |
| K944466 | SealdentEBI · Traditional | 03/02/1995SE |
Questions and answers
When was Cemper cleared by the FDA?
Cemper (K904024) received a 510(k) decision of Substantially Equivalent on November 9, 1990, 71 days after the submission was received.
What is the product code of K904024?
The FDA product code is EMA – Cement, Dental, a Class II (moderate risk) device regulated under 21 CFR 872.3275.