Premier's MultiMatch Universal Chameleon Restorative Composite
FDA 510(k) K223632 · Premier Dental Products Company
510(k) numberK223632
Submission
- Device name
- Premier's MultiMatch Universal Chameleon Restorative Composite
- Applicant
- Premier Dental Products Company
Plymouth Meeting, PA, US - Received
- December 5, 2022
- Decision date
- December 6, 2022
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
- Third-party review
- Yes
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| K262202 | Cerasmart ForteEBF · Traditional | GC America, Inc. | 09/10/2026SE |
| K261695 | Flowable Restorative Material (KP-Flow LF, KP-Flow MF, KP-Flow HF)EBF · Traditional | Guilin Kevin Peter Technology Co., Ltd. | 08/31/2026SE |
| K262228 | Transcend Bulk Fill Flowable CompositeEBF · Traditional | Ultradent Products, Inc. | 07/01/2026SE |
| K261485 | Tetric plus Fill;Tetric plus FlowEBF · Traditional | Ivoclar Vivadent, Inc. | 07/01/2026SE |
| K261246 | SRGC-06EBF · Traditional | GC America, Inc. | 06/18/2026SE |
| K261093 | DiafilEBF · Traditional | DiaDent Group International | 06/02/2026SE |
| K261071 | DIAFIL Bulk FLOW (Economic Package);DIAFIL Bulk FLOW (Refill Package);DIAFIL Bulk FLOW…EBF · Traditional | DiaDent Group International | 05/19/2026SE |
| K260805 | Dual CoreEBF · Traditional | Vericom Co., Ltd. | 05/11/2026SE |
| K261357 | Grandio disc multicolorEBF · Traditional | Voco GmbH | 04/27/2026SE |
| K261356 | Dura-CrownEBF · Special | Hangzhou SHINING3D Dental Technology Co., Ltd. | 04/27/2026SE |
More from Hangzhou SHINING3D Dental Technology Co., Ltd.
| 510(k) | Device | Decision |
|---|---|---|
| K260682 | Bond-PR Universal AdhesiveKLE · Traditional | 03/03/2026SE |
| K253513 | MultiMatch Flow Chameleon AntiMicrobial CompositeEBF · Traditional | 11/07/2025SE |
| K141839 | Premier EtchKLE · Traditional | 11/17/2014SE |
| K132526 | Knit-Pak+MVL · Traditional | 11/26/2013SE |
| K131212 | Premier Ceramic PrimerKLE · Traditional | 08/26/2013SE |
| K083695 | TraxodentMVL · Traditional | 04/28/2009SE |
| K062683 | Enamel Pro VarnishLBH · Traditional | 11/21/2006SE |
| K062166 | Enamel ProEJR · Traditional | 11/21/2006SE |
| K061998 | Premier Self-Etching Bond EnhancerKLE · Traditional | 10/04/2006SE |
| K061997 | Premier Self-Etching Enamel SealantEBC · Traditional | 10/04/2006SE |
Questions and answers
When was Premier's MultiMatch Universal Chameleon Restorative Composite cleared by the FDA?
Premier's MultiMatch Universal Chameleon Restorative Composite (K223632) received a 510(k) decision of Substantially Equivalent on December 6, 2022, 1 days after the submission was received.
What is the product code of K223632?
The FDA product code is EBF – Material, Tooth Shade, Resin, a Class II (moderate risk) device regulated under 21 CFR 872.3690.