FDA 510(k)
FDA class 2
Substantially Equivalent
🇨🇭 Switzerland
CERAMICS2IN1
K Number: K100150
·
Decision May 25, 2010
Classifications
1
FEI Numbers
159
Registration Numbers
159
Same Product Code
471
Applicant Total
11
Review Days
126
Basic Information
- Device Name
- CERAMICS2IN1
- K Number
- K100150
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 872.6660
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- BIODENTA SWISS AG
- Date Received
- January 19, 2010
- Decision Date
- May 25, 2010
- Product Code
- EIH
- 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 |
|---|---|---|---|
| EIH | Powder, Porcelain | FDA class 2 | Dental |
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|---|---|---|---|
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| 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 |