FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ATLANTIS, GEMINI AND GEMINI+ ABUTMENTS IN ZIRCONIA FOR ASTRA IMPLANTS
K Number: K071946
·
Decision Oct 5, 2007
Classifications
1
FEI Numbers
382
Registration Numbers
382
Same Product Code
708
Applicant Total
18
Review Days
84
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Basic Information
- Device Name
- ATLANTIS, GEMINI AND GEMINI+ ABUTMENTS IN ZIRCONIA FOR ASTRA IMPLANTS
- K Number
- K071946
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 872.3630
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Atlantis Components, Inc.
- Date Received
- July 13, 2007
- Decision Date
- October 5, 2007
- Product Code
- NHA
- Advisory Committee
- Dental
- Review Advisory Committee
- DE
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| NHA | Abutment, Implant, Dental, Endosseous | FDA class 2 | Dental |
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Other Clearances by Atlantis Components, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K103020 | ATLANTIS ABUTMENT FOR KEYSTONE IMPLANT, ATLANTIS GEMINI ABUTMENT | Feb 3, 2011 | Substantially Equivalent |
| K073540 | ATLANTIS ABUTMENT IN ZIRCONIA FOR BIOHORIZONS IMPLANT | Feb 29, 2008 | Substantially Equivalent |
| K073258 | ATLANTIS ABUTMENT FOR BIOHORIZON IMPLANTS, ATLANTIS GEMINI ABUTMENT FOR BIOHORIZON IMPLANTS, ATLANTIS GEMINI + ABUTMENT | Feb 14, 2008 | Substantially Equivalent |
| K072483 | ATLANTIS ABUTMENT IN ZIRCONIA FOR 3I CERTAIN MICROAMINI IMPLANTS, GEMINI ABUTMENT IN ZIRCONIA FOR ASTRA IMPLANTS | Nov 16, 2007 | Substantially Equivalent |
| K070833 | ATLANTIS ABUTMENT FOR ASTRA IMPLANT | Jun 22, 2007 | Substantially Equivalent |
| K063734 | ATLANTIS ABUTMENT IN ZIRCONIA FOR 3I CERTAIN INTERFACE | Mar 2, 2007 | Substantially Equivalent |
| K062197 | ATLANTIS ABUTMENT FOR 3I CERTAIN MICRO MINI; GEMINI AND GEMINI+ ABUTMENT | Feb 28, 2007 | Substantially Equivalent |
| K062069 | ATLANTIS ABUTMENT FOR 3I MICROMINI IMPLANT | Feb 14, 2007 | Substantially Equivalent |
| K062277 | ATLANTIS ABUTMENT IN ZIRCONIA FOR NOBEL BIOCARE REPLACE | Dec 20, 2006 | Substantially Equivalent |
| K053654 | ATLANTIS ABUTMENT FOR NOBEL REPLACE INTERFACE | Jul 31, 2006 | Substantially Equivalent |