OptiBond eXTRa Universal
FDA 510(k) K182162 · Kerr Corporation
510(k) numberK182162
Submission
- Device name
- OptiBond eXTRa Universal
- Applicant
- Kerr Corporation
Orange, CA, US - Received
- August 10, 2018
- Decision date
- November 7, 2018
- 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 eXTRa Universal cleared by the FDA?
OptiBond eXTRa Universal (K182162) received a 510(k) decision of Substantially Equivalent on November 7, 2018, 89 days after the submission was received.
What is the product code of K182162?
The FDA product code is KLE – Agent, Tooth Bonding, Resin, a Class II (moderate risk) device regulated under 21 CFR 872.3200.