FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
CLEARFIL TRI-S BOND PLUS
K Number: K111980
·
Decision Oct 14, 2011
Classifications
1
FEI Numbers
137
Registration Numbers
137
Same Product Code
418
Applicant Total
11
Review Days
94
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Basic Information
- Device Name
- CLEARFIL TRI-S BOND PLUS
- K Number
- K111980
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 872.3200
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Kuraray America, 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 America, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K111982 | CLEARFIL DC CORE PLUS | Nov 17, 2011 | Substantially Equivalent |
| K063595 | CLEARFIL MAJESTY POSTERIOR | Feb 9, 2007 | Substantially Equivalent |
| K063593 | CLEARFIL MAJESTY FLOW | Feb 2, 2007 | Substantially Equivalent |
| K063228 | SURFACE COAT | Dec 8, 2006 | Substantially Equivalent |
| K002322 | MODIFICATION TO PANAVIA F | Sep 18, 2000 | Substantially Equivalent |
| K983361 | PANAVIA F | Nov 13, 1998 | Substantially Equivalent |
| K982259 | CHROMA ZONE COLOR STAIN | Sep 22, 1998 | Substantially Equivalent |
| K982164 | ESTENIA | Aug 10, 1998 | Substantially Equivalent |
| K974486 | CLEARFIL LINER BOND 2V | Jan 29, 1998 | Substantially Equivalent |
| K974089 | ALLOY PRIMER | Dec 17, 1997 | Substantially Equivalent |