Proxeo ULTRA (PB-510, PB-520 and PB-530)
FDA 510(k) clearance K223173 · decided 2023-07-14
Clearance details
- K-number
- K223173
- Device name
- Proxeo ULTRA (PB-510, PB-520 and PB-530)
- Applicant
- W&H Dentalwerk Buermoss GmbH
- Decision
- Substantially Equivalent
- Date received
- 2022-10-11
- Decision date
- 2023-07-14
- Days to decision
- 276 days
- Clearance type
- Traditional
- Product code
- ELC
- Device class
- 2
- Regulation number
- 872.4850
- Medical specialty
- Dental
- Advisory committee
- Dental
- Location
- Buermoos, AT
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.