FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
HELIOFORM GOLD-BASED ALLOY
K Number: K990670
·
Decision Apr 2, 1999
Classifications
1
FEI Numbers
42
Registration Numbers
42
Same Product Code
626
Applicant Total
1
Review Days
31
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Basic Information
- Device Name
- HELIOFORM GOLD-BASED ALLOY
- K Number
- K990670
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 872.3060
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- C. Hafner GmbH & Co.
- Date Received
- March 2, 1999
- Decision Date
- April 2, 1999
- 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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