FDA 510(k)
FDA class 2
Substantially Equivalent
🇨🇦 Canada
PREVENT SEAL
K Number: K122521
·
Decision Jun 11, 2013
Classifications
1
FEI Numbers
85
Registration Numbers
85
Same Product Code
130
Applicant Total
8
Review Days
295
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Basic Information
- Device Name
- PREVENT SEAL
- K Number
- K122521
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 872.3765
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Itena Clinical
- Date Received
- August 20, 2012
- Decision Date
- June 11, 2013
- Product Code
- EBC
- 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 |
|---|---|---|---|
| EBC | Sealant, Pit And Fissure, And Conditioner | FDA class 2 | Dental |
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Other Clearances by Itena Clinical
| K Number | Device Name | ||
|---|---|---|---|
| K170207 | Obturys | Jul 31, 2017 | Substantially Equivalent |
| K162960 | TotalC-Ram | Mar 14, 2017 | Substantially Equivalent |
| K122551 | PROVITEMP | Jun 14, 2013 | Substantially Equivalent |
| K122549 | DENTO TEMP | Apr 26, 2013 | Substantially Equivalent |
| K121804 | PROVITEMP, DENTOTEMP, TOTALCEM, DENTOCEM | Apr 19, 2013 | Substantially Equivalent |
| K122522 | DENTOETCH QUICKBOND BOND ACTIVATOR | Mar 19, 2013 | Substantially Equivalent |
| K121769 | DENTOCORE / DENTOCORE BODY | Mar 5, 2013 | Substantially Equivalent |