Rembrandt Porcelain Tinting Kit
FDA 510(k) K864346 · Den-Mat Corp.
510(k) numberK864346
Submission
- Device name
- Rembrandt Porcelain Tinting Kit
- Applicant
- Den-Mat Corp.
Santa Maria, CA, US - Received
- November 4, 1986
- Decision date
- January 7, 1987
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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| K262202 | Cerasmart ForteEBF · Traditional | GC America, Inc. | 09/10/2026SE |
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| 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 |
|---|---|---|
| K983106 | 1ST ImpressionELW · Traditional | 02/09/1999SE |
| K895731 | Den-Mat Cerinate PorcelainEIH · Traditional | 08/03/1990SE |
| K895269 | Den-Mat Lami-QuickELL · Traditional | 02/22/1990SE |
| K881918 | Light-Cured Zionomer CementEMA · Traditional | 07/15/1988SE |
| K875351 | Den-Mat Poretch (Porcelain Etchant)ELL · Traditional | 03/18/1988SE |
| K872510 | Den-Mat TenureEBF · Traditional | 08/24/1987SE |
| K870130 | Den-Mat Secure Anti-Rotational Post-Core SystemELR · Traditional | 02/19/1987SE |
| K862449 | Den-Mat Dentin LinkEBF · Traditional | 07/22/1986SE |
| K860971 | Den-Mat Gold Link (Formerly Den-Mat Metal Opaquer)KLE · Traditional | 03/25/1986SE |
| K852630 | Den-Mat Paint-On Rubber DamEIE · Traditional | 12/18/1985SE |
Questions and answers
When was Rembrandt Porcelain Tinting Kit cleared by the FDA?
Rembrandt Porcelain Tinting Kit (K864346) received a 510(k) decision of Substantially Equivalent on January 7, 1987, 64 days after the submission was received.
What is the product code of K864346?
The FDA product code is EBF – Material, Tooth Shade, Resin, a Class II (moderate risk) device regulated under 21 CFR 872.3690.