ALLFIT IMPLANT SYSTEM, SHORT NECK, MODEL STI RT LENGTH, ALLFIT IMPLANT SYSTEM, LONG NECK, MODEL STI RT LN LENGTH
FDA 510(k) clearance K991822 · decided 2001-08-15
Clearance details
- K-number
- K991822
- Device name
- ALLFIT IMPLANT SYSTEM, SHORT NECK, MODEL STI RT LENGTH, ALLFIT IMPLANT SYSTEM, LONG NECK, MODEL STI RT LN LENGTH
- Applicant
- Dr. Ihde Dental AG Switzerland
- Decision
- Substantially Equivalent
- Date received
- 1999-05-27
- Decision date
- 2001-08-15
- Days to decision
- 811 days
- Clearance type
- Traditional
- Product code
- DZE
- Device class
- 2
- Regulation number
- 872.3640
- Medical specialty
- Dental
- Advisory committee
- Dental
- Location
- New York, NY, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.