FDA 510(k)
FDA class 2
Substantially Equivalent
🇨🇦 Canada
TCB TEMPORARY CROWN AND BRIDGE MATERIAL
K Number: K964691
·
Decision Feb 4, 1997
Classifications
1
FEI Numbers
180
Registration Numbers
180
Same Product Code
188
Applicant Total
9
Review Days
74
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
- TCB TEMPORARY CROWN AND BRIDGE MATERIAL
- K Number
- K964691
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 872.3770
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Scican
- Date Received
- November 22, 1996
- Decision Date
- February 4, 1997
- 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 Scican
| K Number | Device Name | ||
|---|---|---|---|
| K062418 | K-SPRAY, MODEL 085-2715 | Oct 19, 2006 | Substantially Equivalent |
| K021064 | QUANTIM 16 AUTOCLAVE | Aug 8, 2002 | Substantially Equivalent |
| K983679 | STATIM 5000 CASSETTE AUTOCLAVE | Jan 4, 1999 | Substantially Equivalent |
| K962179 | STAT IM 5000 CASSETTE AUTOCLAVE | Jan 13, 1997 | Substantially Equivalent |
| K944036 | STERIMASTER AUTOCLAVE | Oct 2, 1996 | Substantially Equivalent |
| K945142 | POLYSIL (VINYL POLYSILOXAN IMPRESSION MATERIAL) | Jan 11, 1995 | Substantially Equivalent |
| K915054 | STATIM CASSETT AUTOCLAVE, MODIFICATION | Aug 4, 1992 | Substantially Equivalent |
| K910241 | STATIM CASSETTE AUTOCLAVE | May 3, 1991 | Substantially Equivalent |