FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
ENAMEL PRO
K Number: K062166
·
Decision Nov 21, 2006
Classifications
1
FEI Numbers
142
Registration Numbers
142
Same Product Code
76
Applicant Total
41
Review Days
116
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
- ENAMEL PRO
- K Number
- K062166
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 872.6030
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Premier Dental Products Co.
- Date Received
- July 28, 2006
- Decision Date
- November 21, 2006
- Product Code
- EJR
- 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 |
|---|---|---|---|
| EJR | Agent, Polishing, Abrasive, Oral Cavity | FDA class 1 | Dental |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (EJR), ordered by most recent decision date.
AIR-FLOW PLUS Prophylaxis powder
FDA 510(k)
FDA Class 1
·Dental
WHIP MIX PREPPIES PLUS
FDA 510(k)
FDA Class 1
·Dental
NUPRO SENSODYNE PROPHYLAXIS PASTE WITH NOVAMIN
FDA 510(k)
FDA Class 1
·Dental
OSSPRAY SYLC CR
FDA 510(k)
FDA Class 1
·Dental
BUTLER CALCI-FLOR PROPHYLAXIS PASTE
FDA 510(k)
FDA Class 1
·Dental
REMIN PRO
FDA 510(k)
FDA Class 1
·Dental
Other Clearances by Premier Dental Products Co.
| K Number | Device Name | ||
|---|---|---|---|
| K141839 | PREMIER ETCH | Nov 17, 2014 | Substantially Equivalent |
| K132526 | KNIT-PAK+ | Nov 26, 2013 | Substantially Equivalent |
| K131212 | PREMIER CERAMIC PRIMER | Aug 26, 2013 | Substantially Equivalent |
| K083695 | TRAXODENT | Apr 28, 2009 | Substantially Equivalent |
| K062683 | ENAMEL PRO VARNISH | Nov 21, 2006 | Substantially Equivalent |
| K061997 | PREMIER SELF-ETCHING ENAMEL SEALANT | Oct 4, 2006 | Substantially Equivalent |
| K061998 | PREMIER SELF-ETCHING BOND ENHANCER | Oct 4, 2006 | Substantially Equivalent |
| K051866 | PREMIER TEMPORARY CEMENT | Sep 6, 2005 | Substantially Equivalent |
| K042215 | RADIOPAQUE, GLASS IONOMER ENDODONTIC CEMENT | Sep 21, 2004 | Substantially Equivalent |
| K033309 | PREMIER IMPLANT CEMENT, MODEL 3001450 | Jan 26, 2004 | Substantially Equivalent |