ZETAPLUS SOFT
FDA 510(k) clearance K024041 · decided 2002-12-18
Clearance details
- K-number
- K024041
- Device name
- ZETAPLUS SOFT
- Applicant
- Zhermack S.P.A.
- Decision
- Substantially Equivalent
- Date received
- 2002-12-06
- Decision date
- 2002-12-18
- Days to decision
- 12 days
- Clearance type
- Special
- Product code
- ELW
- Device class
- 2
- Regulation number
- 872.3660
- Medical specialty
- Dental
- Advisory committee
- Dental
- Location
- Bend, OR, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.