FDA 510(k)
FDA class 2
Substantially Equivalent
🇨🇭 Switzerland
BIODENTA DENTAL IMPLANT SYSTEM - ABUTMENTS
K Number: K122559
·
Decision May 3, 2013
Classifications
1
FEI Numbers
382
Registration Numbers
382
Same Product Code
708
Applicant Total
11
Review Days
254
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Basic Information
- Device Name
- BIODENTA DENTAL IMPLANT SYSTEM - ABUTMENTS
- K Number
- K122559
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 872.3630
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Biodenta Swiss AG
- Date Received
- August 22, 2012
- Decision Date
- May 3, 2013
- 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 Biodenta Swiss AG
| K Number | Device Name | ||
|---|---|---|---|
| K151295 | Biodenta Customized Abutment - Titanium | Dec 1, 2015 | Substantially Equivalent |
| K150296 | Biodenta Customized Abutment-Hybrid | Jul 2, 2015 | Substantially Equivalent |
| K133884 | BIODENTA DENTAL IMPLANT SYSTEM-BONE LEVEL TAPERED D3.0 AND L6.5MM | Jun 13, 2014 | Substantially Equivalent |
| K123491 | BIODENTA DENTAL IMPLANT SYSTEM - MULTI-USE ABUTMENT | May 30, 2013 | Substantially Equivalent |
| K123512 | BIODENTA DENTAL IMPLANT SYSTEM- BONE LEVEL D 3.0 TO 6.0 MM | Mar 28, 2013 | Substantially Equivalent |
| K123415 | BIODENTA DENTAL IMPLANT SYSTEM- BONE LEVEL TAPERED | Mar 19, 2013 | Substantially Equivalent |
| K111003 | BIODENTA DENTAL IMPLANT SYSTEM - BONE LEVEL | Sep 15, 2011 | Substantially Equivalent |
| K110778 | BIODENTA CUSTOMIZED ABUTMENT | Jul 29, 2011 | Substantially Equivalent |
| K093630 | BIODENTA DENTAL IMPLANT SYSTEM | Jun 3, 2010 | Substantially Equivalent |
| K100150 | CERAMICS2IN1 | May 25, 2010 | Substantially Equivalent |