JINDELL HIGH SPPED AIR TURBINE HANDPIECE, MODELS SW, SP, SU, ETU, MU— 510(k) K062740
Substantially EquivalentJindell Medical Instruments Co., Ltd.
FDA 510(k) clearance K062740 for JINDELL HIGH SPPED AIR TURBINE HANDPIECE, MODELS SW, SP, SU, ETU, MU, Substantially Equivalent on 2006-11-02. Applicant: Jindell Medical Instruments Co., Ltd.. Device class: 1.
Clearance details
- Applicant
- Jindell Medical Instruments Co., Ltd.
- 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
- Hsin-Chu City, TW
Recent devices under product code EFB
view all- K260029 — Firstar Dental Handpieces
- 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)
Adverse 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.