Customized Abutment and Screw
FDA 510(k) clearance K242768 · decided 2025-09-02
Clearance details
- K-number
- K242768
- Device name
- Customized Abutment and Screw
- Applicant
- Chengdu Besmile Medical Technology Co., Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2024-09-13
- Decision date
- 2025-09-02
- Days to decision
- 354 days
- Clearance type
- Abbreviated
- Product code
- NHA
- Device class
- 2
- Regulation number
- 872.3630
- Medical specialty
- Dental
- Advisory committee
- Dental
- Location
- Chengdu, CN
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.