ND LOW SPEED AIRMOTOR AND HANDPIECE, HIGHSPEED AIRTURBINE HANDPIECE, E-TYPE STRAIGHT NOSECONE AND CONTRA ANGLE
FDA 510(k) clearance K073652 · decided 2008-03-20
Clearance details
- K-number
- K073652
- Device name
- ND LOW SPEED AIRMOTOR AND HANDPIECE, HIGHSPEED AIRTURBINE HANDPIECE, E-TYPE STRAIGHT NOSECONE AND CONTRA ANGLE
- Applicant
- Nakamura Magnifier Co., Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2007-12-26
- Decision date
- 2008-03-20
- Days to decision
- 85 days
- Clearance type
- Traditional
- Product code
- EFB
- Device class
- 1
- Regulation number
- 872.4200
- Medical specialty
- Dental
- Advisory committee
- Dental
- Location
- Irvine, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.