OPTIBOND SOLO PLUS 2
FDA 510(k) clearance K991808 · decided 1999-07-09
Clearance details
- K-number
- K991808
- Device name
- OPTIBOND SOLO PLUS 2
- Applicant
- Sybron Dental Specialties, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1999-05-27
- Decision date
- 1999-07-09
- Days to decision
- 43 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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