FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
BIOCCLUS 4
K Number: K960104
·
Decision Feb 6, 1996
Classifications
1
FEI Numbers
42
Registration Numbers
42
Same Product Code
626
Applicant Total
24
Review Days
26
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Basic Information
- Device Name
- BIOCCLUS 4
- K Number
- K960104
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 872.3060
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Degussa Corp.
- Date Received
- January 11, 1996
- Decision Date
- February 6, 1996
- Product Code
- EJT
- Advisory Committee
- Dental
- Review Advisory Committee
- RA
- 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 |
|---|---|---|---|
| EJT | Alloy, Gold-Based Noble Metal | FDA class 2 | Dental |
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FDA 510(k)
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| K951789 | PALLIAG NF IV | Jun 14, 1995 | Substantially Equivalent |
| K951791 | DEPALOR | Jun 12, 1995 | Substantially Equivalent |
| K951788 | DEGULOR S | Jun 12, 1995 | Substantially Equivalent |