FDA 510(k)
FDA class 2
Substantially Equivalent
🇨🇦 Canada
DENTO TEMP
K Number: K122549
·
Decision Apr 26, 2013
Classifications
1
FEI Numbers
144
Registration Numbers
144
Same Product Code
504
Applicant Total
8
Review Days
248
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Basic Information
- Device Name
- DENTO TEMP
- K Number
- K122549
- Device Class
- FDA class 2
- Clearance Type
- Abbreviated
- Regulation Number
- 872.3275
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Itena Clinical
- Date Received
- August 21, 2012
- Decision Date
- April 26, 2013
- Product Code
- EMA
- 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 |
|---|---|---|---|
| EMA | Cement, Dental | 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 |
| K122521 | PREVENT SEAL | Jun 11, 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 |