FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
PHOTO CLEARFIL OPAQUER
K Number: K860708
·
Decision Apr 17, 1986
Classifications
1
FEI Numbers
204
Registration Numbers
204
Same Product Code
931
Applicant Total
25
Review Days
50
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Basic Information
- Device Name
- PHOTO CLEARFIL OPAQUER
- K Number
- K860708
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 872.3690
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Applicant
- Kuraray Co.
- Date Received
- February 26, 1986
- Decision Date
- April 17, 1986
- 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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Other Clearances by Kuraray Co.
| K Number | Device Name | ||
|---|---|---|---|
| K990040 | CLEARFIL SE BOND | Feb 4, 1999 | Substantially Equivalent |
| K951813 | CARIES DETECTOR | Jul 11, 1995 | Substantially Equivalent |
| K933030 | PANAVIA 21 | Feb 24, 1994 | Substantially Equivalent |
| K925383 | PHOTO CLEARFIL OPAQUER | Jan 28, 1993 | Substantially Equivalent |
| 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 |