Optibond Solo Plus 4
FDA 510(k) K014027 · Kerr Dental Materials Center
510(k) numberK014027
Submission
- Device name
- Optibond Solo Plus 4
- Applicant
- Kerr Dental Materials Center
Orange, CA, US - Received
- December 6, 2001
- Decision date
- February 22, 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 Optibond Solo Plus 4 cleared by the FDA?
Optibond Solo Plus 4 (K014027) received a 510(k) decision of Substantially Equivalent on February 22, 2002, 78 days after the submission was received.
What is the product code of K014027?
The FDA product code is KLE – Agent, Tooth Bonding, Resin, a Class II (moderate risk) device regulated under 21 CFR 872.3200.