ATLANTIS ABUTMENT IN ZIRCONIA FOR 3I CERTAIN MICROAMINI IMPLANTS, GEMINI ABUTMENT IN ZIRCONIA FOR ASTRA IMPLANTS
FDA 510(k) clearance K072483 · decided 2007-11-16
Clearance details
- K-number
- K072483
- Device name
- ATLANTIS ABUTMENT IN ZIRCONIA FOR 3I CERTAIN MICROAMINI IMPLANTS, GEMINI ABUTMENT IN ZIRCONIA FOR ASTRA IMPLANTS
- Applicant
- Atlantis Components, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2007-09-04
- Decision date
- 2007-11-16
- Days to decision
- 73 days
- Clearance type
- Traditional
- Product code
- NHA
- Device class
- 2
- Regulation number
- 872.3630
- Medical specialty
- Dental
- Advisory committee
- Dental
- Location
- Skokie, IL, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.