FDA 510(k)
FDA class 2
Substantially Equivalent
🇩🇪 Germany
TEMPXN28
K Number: K073296
·
Decision Jan 9, 2008
Classifications
1
FEI Numbers
180
Registration Numbers
180
Same Product Code
188
Applicant Total
24
Review Days
47
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- TEMPXN28
- K Number
- K073296
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 872.3770
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- 3M Espe AG Dental Products
- Date Received
- November 23, 2007
- Decision Date
- January 9, 2008
- Product Code
- EBG
- 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 |
|---|---|---|---|
| EBG | Crown And Bridge, Temporary, Resin | FDA class 2 | Dental |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (EBG), ordered by most recent decision date.
Dura-Arch
FDA 510(k)
FDA Class 2
·Dental
FLNT Base and FLNT Temp
FDA 510(k)
FDA Class 2
·Dental
TempFIT Temporary Crown and Bridge Resin
FDA 510(k)
FDA Class 2
·Dental
DentaTOOTH
FDA 510(k)
FDA Class 2
·Dental
Evoblock, Perléon
FDA 510(k)
FDA Class 2
·Dental
TEMP MASTER, PMMA-based dental resin
FDA 510(k)
FDA Class 2
·Dental
Other Clearances by 3M Espe AG Dental Products
| K Number | Device Name | ||
|---|---|---|---|
| K100908 | UNICEM HM | Jun 22, 2010 | Substantially Equivalent |
| K100756 | MALTA | Jun 2, 2010 | Substantially Equivalent |
| K094007 | UNICEM | Apr 8, 2010 | Substantially Equivalent |
| K093721 | COSP2 | Feb 19, 2010 | Substantially Equivalent |
| K091826 | ELEGANT | Sep 25, 2009 | Substantially Equivalent |
| K090718 | BELLUS SHADING KIT | Sep 21, 2009 | Substantially Equivalent |
| K080514 | PECD-01 AND PECD QUICK-01 | Mar 26, 2008 | Substantially Equivalent |
| K072055 | LAVA FRAME, LAVA FRAME SHADE | Feb 26, 2008 | Substantially Equivalent |
| K071131 | UNO | Jul 25, 2007 | Substantially Equivalent |
| K071260 | HERMES BOND 3 | Jul 17, 2007 | Substantially Equivalent |