Biscem Translucent, Model D-45011; Biscem Opaque, Model D-45012
FDA 510(k) K082449 · Bisco, Inc.
510(k) numberK082449
Submission
- Device name
- Biscem Translucent, Model D-45011; Biscem Opaque, Model D-45012
- Applicant
- Bisco, Inc.
Schaumburg, IL, US - Received
- August 25, 2008
- Decision date
- September 25, 2008
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
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Questions and answers
When was Biscem Translucent, Model D-45011; Biscem Opaque, Model D-45012 cleared by the FDA?
Biscem Translucent, Model D-45011; Biscem Opaque, Model D-45012 (K082449) received a 510(k) decision of Substantially Equivalent on September 25, 2008, 31 days after the submission was received.
What is the product code of K082449?
The FDA product code is EMA – Cement, Dental, a Class II (moderate risk) device regulated under 21 CFR 872.3275.