DMRC Self-Cure Bracket Adhesive One Step and Primer
FDA 510(k) K142886 · Danville Materials, LLC
510(k) numberK142886
Submission
- Device name
- DMRC Self-Cure Bracket Adhesive One Step and Primer
- Applicant
- Danville Materials, LLC
San Ramon, CA, US - Received
- October 2, 2014
- Decision date
- March 18, 2015
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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Questions and answers
When was DMRC Self-Cure Bracket Adhesive One Step and Primer cleared by the FDA?
DMRC Self-Cure Bracket Adhesive One Step and Primer (K142886) received a 510(k) decision of Substantially Equivalent on March 18, 2015, 167 days after the submission was received.
What is the product code of K142886?
The FDA product code is DYH – Adhesive, Bracket And Tooth Conditioner, Resin, a Class II (moderate risk) device regulated under 21 CFR 872.3750.