FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
DENALI 501CEMENT
K Number: K141503
·
Decision Nov 10, 2014
Classifications
1
FEI Numbers
144
Registration Numbers
144
Same Product Code
504
Applicant Total
9
Review Days
157
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Basic Information
- Device Name
- DENALI 501CEMENT
- K Number
- K141503
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 872.3275
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Denali Corporation
- Date Received
- June 6, 2014
- Decision Date
- November 10, 2014
- 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 Denali Corporation
| K Number | Device Name | ||
|---|---|---|---|
| K153191 | Calcium Bridge | Feb 26, 2016 | Substantially Equivalent |
| K151945 | Triumph Resin Dam | Feb 18, 2016 | Substantially Equivalent |
| K152322 | Resolve 2.0 | Dec 16, 2015 | Substantially Equivalent |
| K132393 | CERCOM II CEMENT | Mar 14, 2014 | Substantially Equivalent |
| K073101 | AURAVENEER CEMENT | Jan 17, 2008 | Substantially Equivalent |
| K071158 | AURALAY PIT & FISSURE SEALANT | Jun 5, 2007 | Substantially Equivalent |
| K070702 | FUSION RESIN CEMENT AND CORE KIT | May 10, 2007 | Substantially Equivalent |
| K070693 | AURAVUE PIT & FISSURE SEALANT | May 9, 2007 | Substantially Equivalent |