Den-Mat Secure Anti-Rotational Post-Core System
FDA 510(k) K870130 · Den-Mat Corp.
510(k) numberK870130
Submission
- Device name
- Den-Mat Secure Anti-Rotational Post-Core System
- Applicant
- Den-Mat Corp.
Santa Maria, CA, US - Received
- January 12, 1987
- Decision date
- February 19, 1987
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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| K872510 | Den-Mat TenureEBF · Traditional | 08/24/1987SE |
| K864346 | Rembrandt Porcelain Tinting KitEBF · Traditional | 01/07/1987SE |
| K862449 | Den-Mat Dentin LinkEBF · Traditional | 07/22/1986SE |
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Questions and answers
When was Den-Mat Secure Anti-Rotational Post-Core System cleared by the FDA?
Den-Mat Secure Anti-Rotational Post-Core System (K870130) received a 510(k) decision of Substantially Equivalent on February 19, 1987, 38 days after the submission was received.
What is the product code of K870130?
The FDA product code is ELR – Post, Root Canal, a Class I (low risk) device regulated under 21 CFR 872.3810.