HIGH SPEED AIR TURBINE HANDPIECES, PAR-4HEX/4HX SERIES (TWIN POWER TURBINE 4H)— 510(k) K061701
Substantially EquivalentJ. Morita USA, Inc.
FDA 510(k) clearance K061701 for HIGH SPEED AIR TURBINE HANDPIECES, PAR-4HEX/4HX SERIES (TWIN POWER TURBINE 4H), Substantially Equivalent on 2006-08-25. Applicant: J. Morita USA, Inc.. Device class: 1.
Clearance details
- Applicant
- J. Morita USA, Inc.
- Product code
- Code EFA
- Device class
- Class 1
- Regulation
- 21 CFR 872.4200
- Advisory panel
- Dental
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Washington, DC, US
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