FDA 510(k)
FDA class 2
Substantially Equivalent
🇨🇭 Switzerland
BIODENTA DENTAL IMPLANT SYSTEM
K Number: K093630
·
Decision Jun 3, 2010
Classifications
1
FEI Numbers
333
Registration Numbers
333
Same Product Code
1516
Applicant Total
11
Review Days
192
Basic Information
- Device Name
- BIODENTA DENTAL IMPLANT SYSTEM
- K Number
- K093630
- 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 23, 2009
- Decision Date
- June 3, 2010
- 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 |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (DZE), ordered by most recent decision date.
HEXIM Implant; Samwon General Abutments
FDA 510(k)
FDA Class 2
·Dental
URIS Long Implant & Abutments
FDA 510(k)
FDA Class 2
·Dental
T3 Pro Implants ZimVie Packaging System
FDA 510(k)
FDA Class 2
·Dental
Bioline Dental Implant System
FDA 510(k)
FDA Class 2
·Dental
MBA Biotech Implant System
FDA 510(k)
FDA Class 2
·Dental
CeraRoot TL Implant System (TL)
FDA 510(k)
FDA Class 2
·Dental
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 |
| K122559 | BIODENTA DENTAL IMPLANT SYSTEM - ABUTMENTS | May 3, 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 |
| K100150 | CERAMICS2IN1 | May 25, 2010 | Substantially Equivalent |