510(k) K231845
K231845 is an FDA 510(k) premarket notification submitted by Foshan Safety Medical Equipment Co., Ltd. for the device "Dental unit Model: Mare". The FDA issued a decision of Substantially Equivalent on Feb 28, 2024. 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
- Feb 28, 2024
- Date Received
- Jun 22, 2023
- 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