SuPro 100
FDA 510(k) K151144 · 3M Deutschland GmbH
510(k) numberK151144
Submission
- Device name
- SuPro 100
- Applicant
- 3M Deutschland GmbH
Seefeld, DE - Received
- April 29, 2015
- Decision date
- September 14, 2015
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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|---|---|---|---|
| K261261 | Dura-ArchEBG · Traditional | Hangzhou SHINING3D Dental Technology Co., Ltd. | 04/17/2026SE |
| K253380 | FLNT Base and FLNT TempEBG · Traditional | Liaoning Upcera Co., Ltd. | 03/02/2026SE |
| K251271 | TempFIT Temporary Crown and Bridge ResinEBG · Traditional | Rizhao Huge Biomaterials Company, Ltd. | 06/23/2025SE |
| K243370 | DentaTOOTHEBG · Traditional | Asiga Pty, Ltd. | 05/05/2025SE |
| K243621 | Evoblock, PerléonEBG · Traditional | Evoden Indústria Comércio Importação E Exportação | 04/22/2025SE |
| K243951 | TEMP MASTER, PMMA-based dental resinEBG · Traditional | Taiwan Dental Materials Co., Ltd. | 02/21/2025SE |
| K242559 | Digital TempEBG · Traditional | Sprintray, Inc. | 11/26/2024SE |
| K231859 | PrimmaArtEBG · Traditional | Dentscare Ltda | 11/26/2024SE |
| K240538 | Premium Teeth ResinEBG · Traditional | Formlabs Ohio, Inc. | 07/19/2024SE |
| K241226 | Fixtemp® C&B 4:1EBG · Special | Dreve Denatmid GmbH | 05/31/2024SE |
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| 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 |
| K140684 | Clinpro Prophy PowderPIP · Traditional | 10/24/2014SE |
| K133436 | Flash Ar; Flash Ar QuickELW · Traditional | 03/07/2014SE |
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Questions and answers
When was SuPro 100 cleared by the FDA?
SuPro 100 (K151144) received a 510(k) decision of Substantially Equivalent on September 14, 2015, 138 days after the submission was received.
What is the product code of K151144?
The FDA product code is EBG – Crown And Bridge, Temporary, Resin, a Class II (moderate risk) device regulated under 21 CFR 872.3770.