Osteon Precision Milled Suprastructure
FDA 510(k) clearance K233083 · decided 2024-03-09
Clearance details
- K-number
- K233083
- Device name
- Osteon Precision Milled Suprastructure
- Applicant
- Implant Solutions Pty Ltd (Aka Osteon Medical)
- Decision
- Substantially Equivalent
- Date received
- 2023-09-26
- Decision date
- 2024-03-09
- Days to decision
- 165 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
+ Add to Predicate Builder ◉ Watch Implant Solutions Pty Ltd (Aka Osteon Medical)
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
Recalls involving this device
No recalls on record reference this clearance.