FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
MINERAL TRIOXIDE AGGREGATE (MTA)
K Number: K964174
·
Decision Feb 10, 1997
Classifications
1
FEI Numbers
71
Registration Numbers
71
Same Product Code
142
Applicant Total
8
Review Days
115
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
- MINERAL TRIOXIDE AGGREGATE (MTA)
- K Number
- K964174
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 872.3820
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Tulsa Dental Products, Ltd.
- Date Received
- October 18, 1996
- Decision Date
- February 10, 1997
- Product Code
- KIF
- 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 |
|---|---|---|---|
| KIF | Resin, Root Canal Filling | FDA class 2 | Dental |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (KIF), ordered by most recent decision date.
Any-Paste
FDA 510(k)
FDA Class 2
·Dental
ZenSeal Pro
FDA 510(k)
FDA Class 2
·Dental
Root canal repair materials (nRoot BP)
FDA 510(k)
FDA Class 2
·Dental
Well-Root PT
FDA 510(k)
FDA Class 2
·Dental
One-Fil Putty Injectable
FDA 510(k)
FDA Class 2
·Dental
MTA vpt
FDA 510(k)
FDA Class 2
·Dental
Other Clearances by Tulsa Dental Products, Ltd.
| K Number | Device Name | ||
|---|---|---|---|
| K970134 | THERMAPREP PLUS OVEN | Mar 21, 1997 | Substantially Equivalent |
| K954790 | PROFILE NICKEL TITANIUM ROTARY INSTRUMENTS | Jan 16, 1996 | Substantially Equivalent |
| K922931 | THERMAPOST ENDODONTIC ROOT CANAL POST | May 26, 1994 | Substantially Equivalent |
| K933582 | PROFILE SERIES 29 FILES | Oct 20, 1993 | Substantially Equivalent |
| K910224 | THERMAPREP | Mar 29, 1991 | Substantially Equivalent |
| K900986 | THERMAFIL ENDODONTIC OBTURATOR | Nov 13, 1990 | Substantially Equivalent |
| K881139 | THERMAFIL ENDODONTIC OBTURATOR | Apr 7, 1988 | Substantially Equivalent |