K243130
- 510(k) number
- K243130
- Device name
- Integral Dental Unit
- Applicant
- Guangdong Yadeng Medical Apparatus Co., Ltd., CN
- Product code
- EIA — Unit, Operative Dental
- Decision date
- 2025-06-27
- Date received
- 2024-09-30
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Dental
510(k) Summary (official FDA PDF): K243130.pdf
Official FDA record: K243130
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.