Build-It Light Cure
FDA 510(k) K091512 · Pentron Clinical Technologies
510(k) numberK091512
Submission
- Device name
- Build-It Light Cure
- Applicant
- Pentron Clinical Technologies
Orange, CA, US - Received
- May 21, 2009
- Decision date
- October 30, 2009
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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Questions and answers
When was Build-It Light Cure cleared by the FDA?
Build-It Light Cure (K091512) received a 510(k) decision of Substantially Equivalent on October 30, 2009, 162 days after the submission was received.
What is the product code of K091512?
The FDA product code is EBF – Material, Tooth Shade, Resin, a Class II (moderate risk) device regulated under 21 CFR 872.3690.