Rmgi Low Viscosity
FDA 510(k) K123265 · Pulpdent Corporation
510(k) numberK123265
Submission
- Device name
- Rmgi Low Viscosity
- Applicant
- Pulpdent Corporation
Watertown, MA, US - Received
- October 19, 2012
- Decision date
- December 7, 2012
- 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 |
|---|---|---|
| K210045 | Activa Presto PackEBF · Traditional | 09/22/2021SE |
| K173020 | OBA-MCP, Orthodontic Bracket Adhesive with MCPDYH · Traditional | 01/17/2018SE |
| K172169 | Pulpdent (Activa) Pit and Fissure Sealant with MCPEBC · Traditional | 01/05/2018SE |
| K153249 | Pulpdent Solo Flowable Composite with MCPEBF · Traditional | 04/01/2016SE |
| K130223 | Rmgi FillEMA · Traditional | 03/29/2013SE |
| K120784 | Tuff-Temp 2.0EBG · Traditional | 06/08/2012SE |
| K120003 | NucalEJK · Traditional | 04/05/2012SE |
| K120213 | Etch-Rite SupremeKLE · Traditional | 03/30/2012SE |
| K113818 | Embrace Wetbond Pit and Fissure Sealant, Low FillEBC · Traditional | 03/21/2012SE |
| K113711 | Lime-Lite IIEJK · Traditional | 03/05/2012SE |
Questions and answers
When was Rmgi Low Viscosity cleared by the FDA?
Rmgi Low Viscosity (K123265) received a 510(k) decision of Substantially Equivalent on December 7, 2012, 49 days after the submission was received.
What is the product code of K123265?
The FDA product code is EMA – Cement, Dental, a Class II (moderate risk) device regulated under 21 CFR 872.3275.