FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
MODIFICATION OF PARAPOST CEMENT
K Number: K993710
·
Decision Dec 21, 1999
Classifications
1
FEI Numbers
144
Registration Numbers
144
Same Product Code
504
Applicant Total
21
Review Days
48
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
- MODIFICATION OF PARAPOST CEMENT
- K Number
- K993710
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 872.3275
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Coltene/Whaledent, Inc.
- Date Received
- November 3, 1999
- Decision Date
- December 21, 1999
- 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/Whaledent, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K071632 | PERFECT TISSUE CONTOURING SYSTEM II | Oct 18, 2007 | Substantially Equivalent |
| K051660 | DENTRONIX DDS 7000 RAPID DRY HEAT STERILIZER STERILIZATION SYSTEM | Aug 4, 2005 | Substantially Equivalent |
| K040551 | COLTOLUX LED CURING LIGHT | Mar 15, 2004 | Substantially Equivalent |
| K033760 | ONE COAT SE BOND | Jan 23, 2004 | Substantially Equivalent |
| K031752 | COLTOSOL F | Aug 5, 2003 | Substantially Equivalent |
| K013400 | SYNERGY FLOW | Dec 10, 2001 | Substantially Equivalent |
| K003034 | COLTENE AURA COMPOMER RESTORATIVE SYSTEM | Nov 30, 2000 | Substantially Equivalent |
| K993545 | TENAX WHITE POST | Apr 14, 2000 | Substantially Equivalent |
| K000311 | PARAPOST FIBER WHITE | Mar 14, 2000 | Substantially Equivalent |
| K993835 | PARAPOST SYSTEM STERILIZABLE ORGANIZER | Dec 16, 1999 | Substantially Equivalent |