Optibond XTR
FDA 510(k) K101423 · Kerr Corporation
510(k) numberK101423
Submission
- Device name
- Optibond XTR
- Applicant
- Kerr Corporation
Orange, CA, US - Received
- May 20, 2010
- Decision date
- July 30, 2010
- 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 XTR cleared by the FDA?
Optibond XTR (K101423) received a 510(k) decision of Substantially Equivalent on July 30, 2010, 71 days after the submission was received.
What is the product code of K101423?
The FDA product code is KLE – Agent, Tooth Bonding, Resin, a Class II (moderate risk) device regulated under 21 CFR 872.3200.