Partial Flex
FDA 510(k) clearance K242897 · decided 2025-06-03
Clearance details
- K-number
- K242897
- Device name
- Partial Flex
- Applicant
- Clemde SA DE CV
- Decision
- Substantially Equivalent
- Date received
- 2024-09-23
- Decision date
- 2025-06-03
- Days to decision
- 253 days
- Clearance type
- Traditional
- Product code
- EBI
- Device class
- 2
- Regulation number
- 872.3760
- Medical specialty
- Dental
- Advisory committee
- Dental
- Location
- Mexico City, MX
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.