Demetron A.2
FDA 510(k) K063116 · Sybron Dental Specialties
510(k) numberK063116
Submission
- Device name
- Demetron A.2
- Applicant
- Sybron Dental Specialties
Newport Beach, CA, US - Received
- October 12, 2006
- Decision date
- December 5, 2006
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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Questions and answers
When was Demetron A.2 cleared by the FDA?
Demetron A.2 (K063116) received a 510(k) decision of Substantially Equivalent on December 5, 2006, 54 days after the submission was received.
What is the product code of K063116?
The FDA product code is EBZ – Activator, Ultraviolet, For Polymerization, a Class II (moderate risk) device regulated under 21 CFR 872.6070.