510(k) K260027
K260027 is an FDA 510(k) premarket notification submitted by FDC Technology Industry Co. for the device "Firstar Dental Electric Motor". The FDA issued a decision of Substantially Equivalent on Oct 1, 2026. The device falls under product code EBW (Controller, Foot, Handpiece And Cord), 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
- Controller, Foot, Handpiece And Cord
- Device Class
- Class I
- Regulation Number
- 872.4200
- Review Panel
- DE
- Submission Type
- 510(k)