L.E.Demetron
FDA 510(k) K021797 · Sybron Dental Specialties, Inc.
510(k) numberK021797
Submission
- Device name
- L.E.Demetron
- Applicant
- Sybron Dental Specialties, Inc.
Orange, CA, US - Received
- May 31, 2002
- Decision date
- June 27, 2002
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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Questions and answers
When was L.E.Demetron cleared by the FDA?
L.E.Demetron (K021797) received a 510(k) decision of Substantially Equivalent on June 27, 2002, 27 days after the submission was received.
What is the product code of K021797?
The FDA product code is EBZ – Activator, Ultraviolet, For Polymerization, a Class II (moderate risk) device regulated under 21 CFR 872.6070.