PROCERA SOFTWARE, MODEL 33145
FDA 510(k) clearance K053602 · decided 2006-02-10
Clearance details
- K-number
- K053602
- Device name
- PROCERA SOFTWARE, MODEL 33145
- Applicant
- Nobel Biocare AB
- Decision
- Substantially Equivalent
- Date received
- 2005-12-23
- Decision date
- 2006-02-10
- Days to decision
- 49 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
No recalls on record reference this clearance.