FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ARGENCO 52HN
K Number: K905811
·
Decision Jan 29, 1991
Classifications
1
FEI Numbers
44
Registration Numbers
44
Same Product Code
626
Applicant Total
217
Review Days
32
Basic Information
- Device Name
- ARGENCO 52HN
- K Number
- K905811
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 872.3060
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Applicant
- ARGEN PRECIOUS METALS, INC.
- Date Received
- December 28, 1990
- Decision Date
- January 29, 1991
- 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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Other Clearances by ARGEN PRECIOUS METALS, INC.
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|---|---|---|---|
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| K954368 | ARGEDENT BIO 87 PF | Oct 7, 1995 | Substantially Equivalent |
| K954371 | SUREFIRE S | Oct 7, 1995 | Substantially Equivalent |
| K954360 | ARGESOL 600 | Oct 7, 1995 | Substantially Equivalent |
| K954367 | ARGISTAR BIO 75PF | Oct 7, 1995 | Substantially Equivalent |