BONART ART-M3II & M4 ULTRASONIC SCALER UNITS WITH ACCESSORIES (INSERTS)
FDA 510(k) clearance K052028 · decided 2005-10-28
Clearance details
- K-number
- K052028
- Device name
- BONART ART-M3II & M4 ULTRASONIC SCALER UNITS WITH ACCESSORIES (INSERTS)
- Applicant
- Bonart Co., Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2005-07-27
- Decision date
- 2005-10-28
- Days to decision
- 93 days
- Clearance type
- Traditional
- Product code
- ELC
- Device class
- 2
- Regulation number
- 872.4850
- Medical specialty
- Dental
- Advisory committee
- Dental
- Location
- Walnut, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.