FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
76 EMA LINING CEMENT
K Number: K851468
·
Decision May 1, 1985
Classifications
1
FEI Numbers
144
Registration Numbers
144
Same Product Code
504
Applicant Total
23
Review Days
15
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
- 76 EMA LINING CEMENT
- K Number
- K851468
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 872.3275
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Applicant
- G-C Intl. Corp.
- Date Received
- April 16, 1985
- Decision Date
- May 1, 1985
- 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 G-C Intl. Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K913175 | MIRACLE MIX CAPS GLASS IONOMER CEMENT INCAPSULES | Dec 27, 1991 | Substantially Equivalent |
| K913884 | FUJI II LC | Oct 30, 1991 | Substantially Equivalent |
| K901999 | FUJI LINING CEMENT LIGHT CURE | Jul 31, 1990 | Substantially Equivalent |
| K902531 | EXAPHASE, SINGLE PHASE IMPRESSION MATERIAL | Jul 13, 1990 | Substantially Equivalent |
| K896883 | GC CERVICAL CEMENT | Jul 6, 1990 | Substantially Equivalent |
| K895976 | TOOTH SHADE RESIN | Dec 22, 1989 | Substantially Equivalent |
| K892806 | TUF-COAT | Jul 14, 1989 | Substantially Equivalent |
| K890830 | DENTURE RESIN | May 1, 1989 | Substantially Equivalent |
| K890829 | UNIFAST LC | Apr 17, 1989 | Substantially Equivalent |
| K883770 | RESUBMITTED EMA DENTIN CEMENT | Nov 30, 1988 | Substantially Equivalent |