FDA 510(k)
FDA class 2
Substantially Equivalent
🇯🇵 Japan
CLEARFIL TRI-S BOND PLUS SINGLE DOSE STANDARD / VALUE / INTRODUCTORY PACK
K Number: K111975
·
Decision Oct 14, 2011
Classifications
1
FEI Numbers
137
Registration Numbers
137
Same Product Code
418
Applicant Total
42
Review Days
94
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Basic Information
- Device Name
- CLEARFIL TRI-S BOND PLUS SINGLE DOSE STANDARD / VALUE / INTRODUCTORY PACK
- K Number
- K111975
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 872.3200
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Kuraray Medical, Inc.
- Date Received
- July 12, 2011
- Decision Date
- October 14, 2011
- 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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Other Clearances by Kuraray Medical, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K120379 | PANAVIA SA CEMENT AUTOMIX VALUE PACK (UNIVERSAL (A2), WHITE) PANAVIA SA CEMENT AUTOMIX (UNIVERSAL (A2), WHITE) PANAVIA S | Mar 30, 2012 | Substantially Equivalent |
| K120378 | PANAVIA SA CEMENT HANDMIX VALUE PACK (UNIVERSAL (A2), WHITE) PANAVIA SA CEMENT HANDMIX (UNIVERSAL (A2), WHITE) PANAVIA S | Mar 30, 2012 | 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 |
| K070325 | CLEARFIL MAJESTY ESTHETIC PLT | Mar 21, 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 |