Den-Mat Cerinate Porcelain
FDA 510(k) K895731 · Den-Mat Corp.
510(k) numberK895731
Submission
- Device name
- Den-Mat Cerinate Porcelain
- Applicant
- Den-Mat Corp.
Santa Maria, CA, US - Received
- September 26, 1989
- Decision date
- August 3, 1990
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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| K262195 | Dandy Ceramic Stain and GlazeEIH · Traditional | Zima International Inc., dba Dandy | 06/30/2026SE |
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| K260067 | Eternal Art Porcelain PowdersEIH · Traditional | Shandong Huge Dental Material Corporation | 04/09/2026SE |
| K260370 | Bloomden Dental Zirconia Blank & Dental Zirconia Pre-Shaded BlankEIH · Traditional | Bloomden Bioceramics (HuNan) Co., Ltd. | 03/30/2026SE |
| K253953 | IPS e.max ZirconiaEIH · Traditional | Ivoclar Vivadent, Inc. | 03/10/2026SE |
More from Ivoclar Vivadent, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K983106 | 1ST ImpressionELW · Traditional | 02/09/1999SE |
| 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 |
| K864346 | Rembrandt Porcelain Tinting KitEBF · Traditional | 01/07/1987SE |
| 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 Den-Mat Cerinate Porcelain cleared by the FDA?
Den-Mat Cerinate Porcelain (K895731) received a 510(k) decision of Substantially Equivalent on August 3, 1990, 311 days after the submission was received.
What is the product code of K895731?
The FDA product code is EIH – Powder, Porcelain, a Class II (moderate risk) device regulated under 21 CFR 872.6660.