MAJOR.BASE 20
FDA 510(k) clearance K081884 · decided 2008-10-08
Clearance details
- K-number
- K081884
- Device name
- MAJOR.BASE 20
- Applicant
- Major Prodotti Dentari S.P.A.
- Decision
- Substantially Equivalent
- Date received
- 2008-07-02
- Decision date
- 2008-10-08
- Days to decision
- 98 days
- Clearance type
- Abbreviated
- Product code
- EBI
- Device class
- 2
- Regulation number
- 872.3760
- Medical specialty
- Dental
- Advisory committee
- Dental
- Location
- Monacalieri (Torino), IT
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.