510(k) K260029
K260029 is an FDA 510(k) premarket notification submitted by FDC Technology Industry Co. for the device "Firstar Dental Handpieces". The FDA issued a decision of Substantially Equivalent on Oct 1, 2026. The device falls under product code EFB (Handpiece, Air-Powered, Dental), a Class I device regulated under 21 CFR 872.4200. FDC Technology Industry Co. has 1 other 510(k) clearance on record.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Oct 1, 2026
- Date Received
- Jan 5, 2026
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device classification
- Device Name
- Handpiece, Air-Powered, Dental
- Device Class
- Class I
- Regulation Number
- 872.4200
- Review Panel
- DE
- Submission Type
- 510(k)