FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
TUFF-TEMP 2.0
K Number: K120784
·
Decision Jun 8, 2012
Classifications
1
FEI Numbers
180
Registration Numbers
180
Same Product Code
188
Applicant Total
32
Review Days
85
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
- TUFF-TEMP 2.0
- K Number
- K120784
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 872.3770
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Pulpdent Corporation
- Date Received
- March 15, 2012
- Decision Date
- June 8, 2012
- 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 Pulpdent Corporation
| K Number | Device Name | ||
|---|---|---|---|
| K210045 | ACTIVA PRESTO PACK | Sep 22, 2021 | Substantially Equivalent |
| K173020 | OBA-MCP, Orthodontic Bracket Adhesive with MCP | Jan 17, 2018 | Substantially Equivalent |
| K172169 | Pulpdent (Activa) Pit and Fissure Sealant with MCP | Jan 5, 2018 | Substantially Equivalent |
| K153249 | Pulpdent Solo Flowable Composite with MCP | Apr 1, 2016 | Substantially Equivalent |
| K130223 | RMGI FILL | Mar 29, 2013 | Substantially Equivalent |
| K123265 | RMGI LOW VISCOSITY | Dec 7, 2012 | Substantially Equivalent |
| K120003 | NUCAL | Apr 5, 2012 | Substantially Equivalent |
| K120213 | ETCH-RITE SUPREME | Mar 30, 2012 | Substantially Equivalent |
| K113818 | EMBRACE WETBOND PIT AND FISSURE SEALANT, LOW FILL | Mar 21, 2012 | Substantially Equivalent |
| K113711 | LIME-LITE II | Mar 5, 2012 | Substantially Equivalent |