FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
MODIFICATION TO CLEARFIL LINER BOND 2V
K Number: K012440
·
Decision Sep 5, 2001
Classifications
1
FEI Numbers
133
Registration Numbers
133
Same Product Code
410
Applicant Total
42
Review Days
36
Basic Information
- Device Name
- MODIFICATION TO CLEARFIL LINER BOND 2V
- K Number
- K012440
- 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 31, 2001
- Decision Date
- September 5, 2001
- 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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