FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
CARIES DETECTOR
K Number: K951813
·
Decision Jul 11, 1995
Classifications
1
FEI Numbers
14
Registration Numbers
14
Same Product Code
16
Applicant Total
25
Review Days
84
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Basic Information
- Device Name
- CARIES DETECTOR
- K Number
- K951813
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 872.1740
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Kuraray Co.
- Date Received
- April 18, 1995
- Decision Date
- July 11, 1995
- Product Code
- LFC
- 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 |
|---|---|---|---|
| LFC | Device, Caries Detection | FDA class 2 | Dental |
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CARIES INDICATOR
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|---|---|---|---|
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| K925404 | CLEARFIL PORCELAIN BOND ACTIVATOR | Jan 11, 1993 | Substantially Equivalent |
| K912708 | CLEARFIL PHOTO ANTERIOR & LINER BOND SYSTEM | Aug 20, 1991 | Substantially Equivalent |
| K912707 | CLEARFIL LINER BOND SYSTEM | Aug 20, 1991 | Substantially Equivalent |
| K910424 | TEETHMATE-F | Apr 3, 1991 | Substantially Equivalent |
| K900690 | CLEARFIL VENEER BOND KIT | Apr 13, 1990 | Substantially Equivalent |
| K897027 | TEETHMATE-A | Mar 14, 1990 | Substantially Equivalent |
| K890123 | CLEARFIL CR INLAY | Mar 31, 1989 | Substantially Equivalent |