GROOVY IMPLANTS
FDA 510(k) clearance K050258 · decided 2005-04-19
Clearance details
- K-number
- K050258
- Device name
- GROOVY IMPLANTS
- Applicant
- Nobel Biocare AB
- Decision
- Substantially Equivalent
- Date received
- 2005-02-03
- Decision date
- 2005-04-19
- Days to decision
- 75 days
- Clearance type
- Traditional
- Product code
- DZE
- Device class
- 2
- Regulation number
- 872.3640
- Medical specialty
- Dental
- Advisory committee
- Dental
- Location
- Yorba Linda,, CA, US
- Third-party review
- No
- Expedited review
- No
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