Suglue 3
FDA 510(k) K192992 · 3M Deutschland GmbH
510(k) numberK192992
Submission
- Device name
- Suglue 3
- Applicant
- 3M Deutschland GmbH
Bavaria, DE - Received
- October 25, 2019
- Decision date
- November 5, 2019
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
- Third-party review
- Yes
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 |
|---|---|---|
| K220257 | PermadyneELW · Traditional | 02/01/2022SE |
| K192961 | ADH19KLE · Traditional | 10/31/2019SE |
| K173318 | Rapid HB, Rapid LB, Rapid MBELW · Traditional | 10/31/2017SE |
| K161922 | XP202EIH · Traditional | 09/01/2016SE |
| K153174 | Ketac Universal AplicapEMA · Traditional | 04/13/2016SE |
| K151748 | Clean & MorePIP · Traditional | 03/11/2016SE |
| K151144 | SuPro 100EBG · Traditional | 09/14/2015SE |
| K140684 | Clinpro Prophy PowderPIP · Traditional | 10/24/2014SE |
| K133436 | Flash Ar; Flash Ar QuickELW · Traditional | 03/07/2014SE |
| K131404 | Flash Ar Penta / Flash Ar Penta QuickELW · Traditional | 05/30/2013SE |
Questions and answers
When was Suglue 3 cleared by the FDA?
Suglue 3 (K192992) received a 510(k) decision of Substantially Equivalent on November 5, 2019, 11 days after the submission was received.
What is the product code of K192992?
The FDA product code is EMA – Cement, Dental, a Class II (moderate risk) device regulated under 21 CFR 872.3275.