DenMat Bulk Fill Composite
FDA 510(k) K242097 · Den-Mat Holdings, LLC
510(k) numberK242097
Submission
- Device name
- DenMat Bulk Fill Composite
- Applicant
- Den-Mat Holdings, LLC
Lompoc, CA, US - Received
- July 18, 2024
- Decision date
- October 15, 2024
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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Questions and answers
When was DenMat Bulk Fill Composite cleared by the FDA?
DenMat Bulk Fill Composite (K242097) received a 510(k) decision of Substantially Equivalent on October 15, 2024, 89 days after the submission was received.
What is the product code of K242097?
The FDA product code is EBF – Material, Tooth Shade, Resin, a Class II (moderate risk) device regulated under 21 CFR 872.3690.