510(k) K242404
K242404 is an FDA 510(k) premarket notification submitted by Bdc Dental Corporation , Ltd. for the device "BDC Dental Unit". The FDA issued a decision of Substantially Equivalent on February 7, 2025. The device falls under product code EIA (Unit, Operative Dental), a Class I device regulated under 21 CFR 872.6640. Bdc Dental Corporation , Ltd. has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 7, 2025
- Date Received
- August 13, 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