Codent Low Speed Dental Handpieces and Accessories— 510(k) K150798
Substantially EquivalentCodent Technical Industry Co., Ltd.
FDA 510(k) clearance K150798 for Codent Low Speed Dental Handpieces and Accessories, Substantially Equivalent on 2015-04-24. Applicant: Codent Technical Industry Co., Ltd.. Device class: 1.
Clearance details
- Applicant
- Codent Technical Industry 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
- Special
- Location
- Kaohsiung 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)
More clearances from Codent Technical Industry Co., Ltd.
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.