MODEL MS-2 HANDPIECE— 510(k) K982050
Substantially EquivalentParkell, Inc.
FDA 510(k) clearance K982050 for MODEL MS-2 HANDPIECE, Substantially Equivalent on 1998-09-02. Applicant: Parkell, Inc.. Device class: 1.
Clearance details
- Applicant
- Parkell, Inc.
- 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
- Farmingdale, NY, US
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 Parkell, Inc.
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.