FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
CLEARFIL MAJESTY ESTHETIC PLT
K Number: K070325
·
Decision Mar 21, 2007
Classifications
1
FEI Numbers
204
Registration Numbers
204
Same Product Code
931
Applicant Total
42
Review Days
44
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Basic Information
- Device Name
- CLEARFIL MAJESTY ESTHETIC PLT
- K Number
- K070325
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 872.3690
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Kuraray Medical, Inc.
- Date Received
- February 5, 2007
- Decision Date
- March 21, 2007
- Product Code
- EBF
- 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 |
|---|---|---|---|
| EBF | Material, Tooth Shade, Resin | FDA class 2 | Dental |
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|---|---|---|---|
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| K111975 | CLEARFIL TRI-S BOND PLUS SINGLE DOSE STANDARD / VALUE / INTRODUCTORY PACK | Oct 14, 2011 | Substantially Equivalent |
| K100328 | CLEARFIL MAJETY POSTERIOR | Mar 5, 2010 | Substantially Equivalent |
| K092281 | CLEARFIL MAJESTY POSTERIOR PLT | Oct 27, 2009 | Substantially Equivalent |
| K081583 | CLEARFIL SA CEMENT | Jul 28, 2008 | Substantially Equivalent |
| K071169 | CLEARFIL MAJESTY POSTERIOR PLT | Jun 20, 2007 | Substantially Equivalent |
| K062409 | K-ETCHANT GEL | Nov 8, 2006 | Substantially Equivalent |
| K061906 | CLEARFIL CERAMIC PRIMER | Sep 28, 2006 | Substantially Equivalent |
| K062382 | CLEARFIL DC BOND | Sep 27, 2006 | Substantially Equivalent |