FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ALL-BOND UNIVERSAL SC (NOT FINALIZED)
K Number: K131734
·
Decision Apr 11, 2014
Classifications
1
FEI Numbers
133
Registration Numbers
133
Same Product Code
410
Applicant Total
79
Review Days
302
Basic Information
- Device Name
- ALL-BOND UNIVERSAL SC (NOT FINALIZED)
- K Number
- K131734
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 872.3200
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- BISCO, INC.
- Date Received
- June 13, 2013
- Decision Date
- April 11, 2014
- 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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