CAD/CAMouflage Milling Block
FDA 510(k) K162537 · Prismatik Dentalcraft, Inc.
510(k) numberK162537
Submission
- Device name
- CAD/CAMouflage Milling Block
- Applicant
- Prismatik Dentalcraft, Inc.
Irvine, CA, US - Received
- September 12, 2016
- Decision date
- November 16, 2016
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
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Questions and answers
When was CAD/CAMouflage Milling Block cleared by the FDA?
CAD/CAMouflage Milling Block (K162537) received a 510(k) decision of Substantially Equivalent on November 16, 2016, 65 days after the submission was received.
What is the product code of K162537?
The FDA product code is EBF – Material, Tooth Shade, Resin, a Class II (moderate risk) device regulated under 21 CFR 872.3690.