NOBELACTIVE MULTI UNIT ABUTMENT
FDA 510(k) clearance K072570 · decided 2007-12-28
Clearance details
- K-number
- K072570
- Device name
- NOBELACTIVE MULTI UNIT ABUTMENT
- Applicant
- Nobel Biocare AB
- Decision
- Substantially Equivalent
- Date received
- 2007-09-12
- Decision date
- 2007-12-28
- Days to decision
- 107 days
- Clearance type
- Traditional
- Product code
- NHA
- Device class
- 2
- Regulation number
- 872.3630
- Medical specialty
- Dental
- Advisory committee
- Dental
- Location
- Yorba Linda,, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Nobel Biocare 17 Multi-Unit Abutment, Conical Connection NP, 2.5mm, REF 36614. Product Usa recall (Z-2529-2018) | Nobel Biocare Usa Llc | 2018-07-23 |