FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
COLTOSOL TEMPORARY ENDODONTIC FILLING MATERIAL
K Number: K902392
·
Decision Aug 28, 1990
Classifications
1
FEI Numbers
144
Registration Numbers
144
Same Product Code
504
Applicant Total
13
Review Days
90
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
- COLTOSOL TEMPORARY ENDODONTIC FILLING MATERIAL
- K Number
- K902392
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 872.3275
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Applicant
- Coltene, Inc.
- Date Received
- May 30, 1990
- Decision Date
- August 28, 1990
- 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 |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (EMA), ordered by most recent decision date.
G-CEM UNIVERSAL
FDA 510(k)
FDA Class 2
·Dental
REGEN Bioactive Cement
FDA 510(k)
FDA Class 2
·Dental
Bifix Veneer LC, Bifix Veneer Try-In
FDA 510(k)
FDA Class 2
·Dental
iCEM Universal Plus
FDA 510(k)
FDA Class 2
·Dental
TopCEM Vigor SA Self-Adhesive Resin Cement
FDA 510(k)
FDA Class 2
·Dental
GlasIonomer FX-LC
FDA 510(k)
FDA Class 2
·Dental
Other Clearances by Coltene, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K882800 | COLTENE PRESIDENT JET REGULAR BODY | Sep 23, 1988 | Substantially Equivalent |
| K873671 | COLTENE PRESIDENT JET IMPRESSION MATERIALS SYSTEM | Oct 27, 1987 | Substantially Equivalent |
| K870266 | COLTENE BRILLIANT D.I. DIRECT INLAY SYSTEM | Feb 27, 1987 | Substantially Equivalent |
| K870047 | COLTENE RAPID | Jan 29, 1987 | Substantially Equivalent |
| K863998 | COLTENE JET-MIXER | Oct 30, 1986 | Substantially Equivalent |
| K850036 | COLTENE PRECISE | Feb 8, 1985 | Substantially Equivalent |
| K840297 | COLTENE ORALLOY MAGICAPS | Mar 16, 1984 | Substantially Equivalent |
| K811767 | COLTENE PRESIDENT IMPRESSION MATERIALS | Jul 15, 1981 | Substantially Equivalent |
| K811667 | COLTENE PRESSURE SPOT INDICATOR | Jul 15, 1981 | Substantially Equivalent |
| K811666 | COLTENE COLTEX/COLTOFLAX | Jul 15, 1981 | Substantially Equivalent |