KAVO QUATTROCARE
FDA 510(k) clearance K012308 · decided 2002-06-26
Clearance details
- K-number
- K012308
- Device name
- KAVO QUATTROCARE
- Applicant
- Kavo America
- Decision
- Substantially Equivalent
- Date received
- 2001-07-23
- Decision date
- 2002-06-26
- Days to decision
- 338 days
- Clearance type
- Traditional
- Product code
- EFB
- Device class
- 1
- Regulation number
- 872.4200
- Medical specialty
- Dental
- Advisory committee
- Dental
- Location
- Lake Zurich, IL, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| KaVo QUATTROcare Spray, 500 ml aerosol can; a maintenance spray for lubrication of KaVo tu recall (Z-0289-2007) | Kavo America Corporation | 2006-12-19 |