FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
VITABLOCS
K Number: K102128
·
Decision Aug 11, 2010
Classifications
1
FEI Numbers
158
Registration Numbers
158
Same Product Code
481
Applicant Total
6
Review Days
13
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Basic Information
- Device Name
- VITABLOCS
- K Number
- K102128
- Device Class
- FDA class 2
- Clearance Type
- Abbreviated
- Regulation Number
- 872.6660
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Vita Zahnfabrik H.Rauter GmbH & Co.
- Date Received
- July 29, 2010
- Decision Date
- August 11, 2010
- Product Code
- EIH
- Advisory Committee
- Dental
- Review Advisory Committee
- DE
- Third Party
- Y
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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|---|---|---|---|
| K243940 | VITA YZ Multi Translucent | Feb 21, 2025 | Substantially Equivalent |
| K152373 | VITA VM LC Flow | Dec 30, 2015 | Substantially Equivalent |
| K132070 | VITA SUPRINITY(R) | Jan 31, 2014 | Substantially Equivalent |
| K122269 | ENAMIC | Dec 13, 2012 | Substantially Equivalent |
| K090644 | VITABLOCS, MODEL VX55-**** | Mar 31, 2009 | Substantially Equivalent |