CHIROPRO L SYSTEM
FDA 510(k) clearance K092214 · decided 2009-12-15
Clearance details
- K-number
- K092214
- Device name
- CHIROPRO L SYSTEM
- Applicant
- Bien-Air Dental, SA
- Decision
- Substantially Equivalent
- Date received
- 2009-07-22
- Decision date
- 2009-12-15
- Days to decision
- 146 days
- Clearance type
- Traditional
- Product code
- EBW
- Device class
- 1
- Regulation number
- 872.4200
- Medical specialty
- Dental
- Advisory committee
- Dental
- Location
- North Attleboro, MA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Osseocare Pro Console & Set Osseocare Pro, Model 1600870-001, 1700470-001, and 1700471-001 recall (Z-0273-2014) | Nobel Biocare Usa Llc | 2013-11-13 |