OptiBond eXTRa Universal
FDA 510(k) clearance K182162 · decided 2018-11-07
Clearance details
- K-number
- K182162
- Device name
- OptiBond eXTRa Universal
- Applicant
- Kerr Corporation
- Decision
- Substantially Equivalent
- Date received
- 2018-08-10
- Decision date
- 2018-11-07
- Days to decision
- 89 days
- Clearance type
- Traditional
- Product code
- KLE
- Device class
- 2
- Regulation number
- 872.3200
- Medical specialty
- Dental
- Advisory committee
- Dental
- Location
- Orange, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.