FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
GRANITEC Z2, ZINC PHOSPHATE CEMENT
K Number: K896649
·
Decision Feb 22, 1990
Classifications
1
FEI Numbers
144
Registration Numbers
144
Same Product Code
504
Applicant Total
31
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
- GRANITEC Z2, ZINC PHOSPHATE CEMENT
- K Number
- K896649
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 872.3275
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Applicant
- Confi-Dental Products Co.
- Date Received
- November 24, 1989
- Decision Date
- February 22, 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 Confi-Dental Products Co.
| K Number | Device Name | ||
|---|---|---|---|
| K030807 | CARIES INDICATOR | Jun 9, 2003 | Substantially Equivalent |
| K030743 | ETCHANT 40% | May 9, 2003 | Substantially Equivalent |
| K955328 | CONFI-BOND | Mar 28, 1996 | Substantially Equivalent |
| K955329 | RESILIENCE M5 PROTECTION PLUS | Mar 28, 1996 | Substantially Equivalent |
| K954988 | CRYSTALLESSENCE | Mar 8, 1996 | Substantially Equivalent |
| K952930 | DENTRAY II PLUS TRAY ADHESIVE | Sep 8, 1995 | Substantially Equivalent |
| K946307 | CYRSTALLINE L3 MULTI-USE HYBRID COMPOSITE | Jan 26, 1995 | Substantially Equivalent |
| K940546 | GRANITEC IONOMER RESIN CEMENT | Apr 29, 1994 | Substantially Equivalent |
| K936070 | TREND SET 2 PLUS | Feb 4, 1994 | Substantially Equivalent |
| K935714 | CRYSTALLINE L3 MULTI-USE HYBRID COMPOSITE | Jan 21, 1994 | Substantially Equivalent |