FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
PREMIER CERAMIC PRIMER
K Number: K131212
·
Decision Aug 26, 2013
Classifications
1
FEI Numbers
133
Registration Numbers
133
Same Product Code
410
Applicant Total
41
Review Days
119
Basic Information
- Device Name
- PREMIER CERAMIC PRIMER
- K Number
- K131212
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 872.3200
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- PREMIER DENTAL PRODUCTS CO.
- Date Received
- April 29, 2013
- Decision Date
- August 26, 2013
- Product Code
- KLE
- 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 |
|---|---|---|---|
| KLE | Agent, Tooth Bonding, Resin | FDA class 2 | Dental |
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| K061997 | PREMIER SELF-ETCHING ENAMEL SEALANT | Oct 4, 2006 | Substantially Equivalent |
| K051866 | PREMIER TEMPORARY CEMENT | Sep 6, 2005 | Substantially Equivalent |
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