SCALLOPED ENDOPORE ENDOSSEOUS DENTAL IMPLANT SYSTEM
FDA 510(k) clearance K043190 · decided 2004-12-14
Clearance details
- K-number
- K043190
- Device name
- SCALLOPED ENDOPORE ENDOSSEOUS DENTAL IMPLANT SYSTEM
- Applicant
- Innova Life Sciences Corp.
- Decision
- Substantially Equivalent
- Date received
- 2004-11-17
- Decision date
- 2004-12-14
- Days to decision
- 27 days
- Clearance type
- Special
- Product code
- NHA
- Device class
- 2
- Regulation number
- 872.3630
- Medical specialty
- Dental
- Advisory committee
- Dental
- Location
- Washington, DC, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.