Den-Mat Poretch (Porcelain Etchant)
FDA 510(k) K875351 · Den-Mat Corp.
510(k) numberK875351
Submission
- Device name
- Den-Mat Poretch (Porcelain Etchant)
- Applicant
- Den-Mat Corp.
Santa Maria, CA, US - Received
- December 31, 1987
- Decision date
- March 18, 1988
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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| K060530 | SD Ceramic Coping for Quick Abutment, Locking. Model 45301. RD Ceramic Coping for Quick…ELL · Traditional | Lifecore Biomedical, Inc. | 05/22/2006SE |
| K041283 | Procera Bridge ZirconiaELL · Traditional | Nobel Biocare AB | 05/28/2004SE |
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| K965216 | Argi-Satin or OPTI0-STARELL · Traditional | Argen Precious Metals, Inc. | 02/27/1997SE |
| K960770 | Matchmaker/Propaque PorcelainELL · Traditional | Davis Schottlander & Davis, Ltd. | 11/19/1996SE |
More from Davis Schottlander & Davis, 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 |
| 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 Poretch (Porcelain Etchant) cleared by the FDA?
Den-Mat Poretch (Porcelain Etchant) (K875351) received a 510(k) decision of Substantially Equivalent on March 18, 1988, 78 days after the submission was received.
What is the product code of K875351?
The FDA product code is ELL – Teeth, Porcelain, a Class II (moderate risk) device regulated under 21 CFR 872.3920.