Den-Mat Gold Link (Formerly Den-Mat Metal Opaquer)
FDA 510(k) K860971 · Den-Mat Corp.
510(k) numberK860971
Submission
- Device name
- Den-Mat Gold Link (Formerly Den-Mat Metal Opaquer)
- Applicant
- Den-Mat Corp.
Santa Maria, CA, US - Received
- March 4, 1986
- Decision date
- March 25, 1986
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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| K252469 | Magnabond Se; Magnabond Universal; Magnabond Universal DcaKLE · Traditional | Dmp Dental Industry S.A. | 11/06/2025SE |
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| K242749 | TopCEM Ceramic Primer Ceramic Coupling AgentKLE · Traditional | Rizhao Huge Biomaterials Company, Ltd. | 11/08/2024SE |
More from Rizhao Huge Biomaterials Company, 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 |
| K864346 | Rembrandt Porcelain Tinting KitEBF · Traditional | 01/07/1987SE |
| K862449 | Den-Mat Dentin LinkEBF · Traditional | 07/22/1986SE |
| K852630 | Den-Mat Paint-On Rubber DamEIE · Traditional | 12/18/1985SE |
Questions and answers
When was Den-Mat Gold Link (Formerly Den-Mat Metal Opaquer) cleared by the FDA?
Den-Mat Gold Link (Formerly Den-Mat Metal Opaquer) (K860971) received a 510(k) decision of Substantially Equivalent on March 25, 1986, 21 days after the submission was received.
What is the product code of K860971?
The FDA product code is KLE – Agent, Tooth Bonding, Resin, a Class II (moderate risk) device regulated under 21 CFR 872.3200.