BellaTek Bars
FDA 510(k) clearance K241032 · decided 2024-07-15
Clearance details
- K-number
- K241032
- Device name
- BellaTek Bars
- Applicant
- Biomet 3i, LLC
- Decision
- Substantially Equivalent
- Date received
- 2024-04-16
- Decision date
- 2024-07-15
- Days to decision
- 90 days
- Clearance type
- Traditional
- Product code
- NHA
- Device class
- 2
- Regulation number
- 872.3630
- Medical specialty
- Dental
- Advisory committee
- Dental
- Location
- Palm Beach Gardens, FL, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.