FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
CAMLOG ABUTMENTS PS
K Number: K090347
·
Decision Jun 18, 2009
Classifications
1
FEI Numbers
382
Registration Numbers
382
Same Product Code
708
Applicant Total
14
Review Days
127
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Basic Information
- Device Name
- CAMLOG ABUTMENTS PS
- K Number
- K090347
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 872.3630
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Altatec GmbH
- Date Received
- February 11, 2009
- Decision Date
- June 18, 2009
- 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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|---|---|---|---|
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| K160784 | CAM Titanium Blanks | Sep 14, 2016 | Substantially Equivalent |
| K153779 | Abutment for Bridges | Mar 31, 2016 | Substantially Equivalent |
| K152509 | CAMLOG and CONELOG Abutments for Screw-retained Restorations (ASR) | Jan 12, 2016 | Substantially Equivalent |
| K151599 | iSy Implant System | Oct 2, 2015 | Substantially Equivalent |
| K143337 | CONELOG Titanium base CAD/CAM | Feb 17, 2015 | Substantially Equivalent |
| K133991 | ISY | Aug 6, 2014 | Substantially Equivalent |
| K113779 | CONELOG IMPLANT SYSTEM | Dec 14, 2012 | Substantially Equivalent |
| K103252 | CAMLOG VARIO SR ABUTMENTS | Jan 10, 2011 | Substantially Equivalent |
| K083496 | CAMLOG IMPLANT SYSTEM MODIFIED IMPLANTS AND ABUTMENTS | Jan 30, 2009 | Substantially Equivalent |