PROPHY-MATE MOTOR HANDPIECE, MODELS PROPHY-MATE (2000 RPM MAX), ENDO-MATE (600RPM MAX.)— 510(k) K990682
Substantially EquivalentNsk Nakanishi, Inc.
FDA 510(k) clearance K990682 for PROPHY-MATE MOTOR HANDPIECE, MODELS PROPHY-MATE (2000 RPM MAX), ENDO-MATE (600RPM MAX.), Substantially Equivalent on 1999-03-24. Applicant: Nsk Nakanishi, Inc.. Device class: 1.
Clearance details
- Applicant
- Nsk Nakanishi, Inc.
- Product code
- Code EKX
- Device class
- Class 1
- Regulation
- 21 CFR 872.4200
- Advisory panel
- Dental
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Tochigi-Ken, JP
Recent devices under product code EKX
view allMore clearances from Nsk Nakanishi, Inc.
view all- K991701 — MACH-SIGMA HANDPIECE, ULTRAPUSH, MODELS MACH-SIGMA MU (MINI HEAD), MACH-SIGMA SU (STD. HEAD), MACH-SIGMA TU (TORQUE HD)
- K991021 — SONIC SCALER WITH FIBER OPTIC, MODEL NAS-L, SONIC SCALER WITHOUT FIBER OPTIC, MODEL NAS-NL
- K990954 — ELEC-MATE, MODELS EX-6 SET, EX-6L SET, EX-30 SET
- K990646 — PORTABLE ELECTRIC MOTOR-HANDPIECE UNIT, HANDY-MATE
- K980162 — MACH-SIGMA HANDPIECE, ULTRAPUSH
Data sourced from openFDA. This site is unofficial and independent of the FDA.