FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
CLEARFIL ST OPAQUER
K Number: K001913
·
Decision Aug 4, 2000
Classifications
1
FEI Numbers
204
Registration Numbers
204
Same Product Code
931
Applicant Total
10
Review Days
42
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Basic Information
- Device Name
- CLEARFIL ST OPAQUER
- K Number
- K001913
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 872.3690
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Kuraray Company, Ltd.
- Date Received
- June 23, 2000
- Decision Date
- August 4, 2000
- 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 Company, Ltd.
| K Number | Device Name | ||
|---|---|---|---|
| K001914 | CLEARFIL REPAIR | Aug 10, 2000 | Substantially Equivalent |
| K980232 | CLEARFIL DC CEMENT | Feb 24, 1998 | Substantially Equivalent |
| K965091 | TEETHMATE F-1 | Mar 27, 1997 | Substantially Equivalent |
| K943166 | CLEARFIL LINER BOND SYSTEM | Aug 10, 1994 | Substantially Equivalent |
| K943167 | CLEARFIL NEW BOND | Aug 10, 1994 | Substantially Equivalent |
| K943168 | CLEARFIL AP-X | Aug 10, 1994 | Substantially Equivalent |
| K943169 | CLEARFIL AP-X AND LINER BOND 2 | Aug 10, 1994 | Substantially Equivalent |
| K943170 | CLEARFIL LINER BOND 2 | Aug 10, 1994 | Substantially Equivalent |
| K943165 | CLEARFIL PHOTO BOND | Aug 10, 1994 | Substantially Equivalent |