FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
CONNECT
K Number: K900303
·
Decision Apr 12, 1990
Classifications
1
FEI Numbers
144
Registration Numbers
144
Same Product Code
504
Applicant Total
8
Review Days
80
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
- CONNECT
- K Number
- K900303
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 872.3275
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Applicant
- Parkell
- Date Received
- January 22, 1990
- Decision Date
- April 12, 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 Parkell
| K Number | Device Name | ||
|---|---|---|---|
| K923867 | METAFIL | Oct 6, 1992 | Substantially Equivalent |
| K905032 | MOUSSE, POLYVINYL SILOXANE IMPRESSION MATERIAL | Mar 15, 1991 | Substantially Equivalent |
| K896719 | PRIMER-P ADHESIVE AGENT | Feb 22, 1990 | Substantially Equivalent |
| K895750 | HEMA-PRIMER | Dec 21, 1989 | Substantially Equivalent |
| K892003 | ABRAKADABRA - DENTAL ADHESIVE SYSTEM | Jun 7, 1989 | Substantially Equivalent |
| K884918 | PORCELAIN ETCHING GEL AND ETCHING GEL BARRIER | Feb 13, 1989 | Substantially Equivalent |
| K881914 | COVER UP | Jul 15, 1988 | Substantially Equivalent |