Integral Dental Unit
FDA 510(k) clearance K243130 · decided 2025-06-27
Clearance details
- K-number
- K243130
- Device name
- Integral Dental Unit
- Applicant
- Guangdong Yadeng Medical Apparatus Co., Ltd.,
- Decision
- Substantially Equivalent
- Date received
- 2024-09-30
- Decision date
- 2025-06-27
- Days to decision
- 270 days
- Clearance type
- Traditional
- Product code
- EIA
- Device class
- 1
- Regulation number
- 872.6640
- Medical specialty
- Dental
- Advisory committee
- Dental
- Location
- Foshan, CN
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.