Osteon Precision Milled Suprastructure
FDA 510(k) clearance K212676 · decided 2022-03-03
Clearance details
- K-number
- K212676
- Device name
- Osteon Precision Milled Suprastructure
- Applicant
- Implant Solutions Pty Ltd (Osteon Medical)
- Decision
- Substantially Equivalent
- Date received
- 2021-08-24
- Decision date
- 2022-03-03
- Days to decision
- 191 days
- Clearance type
- Traditional
- Product code
- NHA
- Device class
- 2
- Regulation number
- 872.3630
- Medical specialty
- Dental
- Advisory committee
- Dental
- Location
- Mulgrave, AU
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.