FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
PALLIAG NF IV
K Number: K951789
·
Decision Jun 14, 1995
Classifications
1
FEI Numbers
42
Registration Numbers
42
Same Product Code
626
Applicant Total
24
Review Days
58
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Basic Information
- Device Name
- PALLIAG NF IV
- K Number
- K951789
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 872.3060
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Degussa Corp.
- Date Received
- April 17, 1995
- Decision Date
- June 14, 1995
- Product Code
- EJT
- 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 |
|---|---|---|---|
| EJT | Alloy, Gold-Based Noble Metal | FDA class 2 | Dental |
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| K951791 | DEPALOR | Jun 12, 1995 | Substantially Equivalent |
| K951788 | DEGULOR S | Jun 12, 1995 | Substantially Equivalent |