FDA 510(k)
FDA class 2
Substantially Equivalent
🇨🇭 Switzerland
BIODENTA DENTAL IMPLANT SYSTEM- BONE LEVEL TAPERED
K Number: K123415
·
Decision Mar 19, 2013
Classifications
1
FEI Numbers
333
Registration Numbers
333
Same Product Code
1516
Applicant Total
11
Review Days
134
Basic Information
- Device Name
- BIODENTA DENTAL IMPLANT SYSTEM- BONE LEVEL TAPERED
- K Number
- K123415
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 872.3640
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- BIODENTA SWISS AG
- Date Received
- November 5, 2012
- Decision Date
- March 19, 2013
- Product Code
- DZE
- 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 |
|---|---|---|---|
| DZE | Implant, Endosseous, Root-Form | FDA class 2 | Dental |
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|---|---|---|---|
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| K133884 | BIODENTA DENTAL IMPLANT SYSTEM-BONE LEVEL TAPERED D3.0 AND L6.5MM | Jun 13, 2014 | Substantially Equivalent |
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| 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 |