Firstar Dental Handpieces— 510(k) K260029
Substantially EquivalentFDC Technology Industry Co.
FDA 510(k) clearance K260029 for Firstar Dental Handpieces, Substantially Equivalent on 2026-10-01. Applicant: FDC Technology Industry Co.. Device class: 1.
Summary
Firstar Dental Handpieces from FDC Technology Industry are filed under EFB, air-powered dental handpieces. The record doesn't list the individual handpiece models.
Class I, 21 CFR 872.4200. The Dental panel reviewed it as a Traditional 510(k).
FDC Technology filed from Kent, Washington. The review clock ran 269 days, from January 5 to October 1, 2026, matching the company's Firstar Dental Electric Motor (K260027).
Clearance details
- Applicant
- FDC Technology Industry Co.
- Product code
- Product code EFB
- Device class
- Class 1
- Regulation
- 21 CFR 872.4200
- Advisory panel
- Dental
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Kent, WA, US
Recent devices under product code EFB
view all- K262144 — DIAMED Handpiece; DIAMED Airmotor; DIAMED Airmotor Handpiece
- K251388 — Dental air-motor handpiece (TM-203B2, TM-203M4, TM-205B2, TM-205M4, TM-IS, TM-ES, TM-SG20, TM-X25, TM-BB, TM-IC, TM-RA41)
- K251389 — High speed air turbine handpiece
- K242179 — Synea Fusion Handpieces (Intensiv & Profin)
- K240337 — Dental Handpiece (Model: J6-126, J6-136, SH11W2, SH11W3, W401LW, W15LW, W142LW, W11L)
More clearances from FDC Technology Industry Co.
view allAdverse events under product code EFB
product code EFB- Injury
- 133
- Malfunction
- 562
- Total
- 695
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.