510(k) K243130
K243130 is an FDA 510(k) premarket notification submitted by Guangdong Yadeng Medical Apparatus Co., Ltd., for the device "Integral Dental Unit". The FDA issued a decision of Substantially Equivalent on June 27, 2025. The device falls under product code EIA (Unit, Operative Dental), a Class I device regulated under 21 CFR 872.6640.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- June 27, 2025
- Date Received
- September 30, 2024
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Unit, Operative Dental
- Device Class
- Class I
- Regulation Number
- 872.6640
- Review Panel
- DE
- Submission Type