510(k) K231297
K231297 is an FDA 510(k) premarket notification submitted by Firstar Dental Company for the device "Firstar Dental Unit". The FDA issued a decision of Substantially Equivalent on January 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
- January 27, 2025
- Date Received
- May 4, 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