FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ARGELOY PARTIAL (NON-PRECIOUS)
K Number: K935829
·
Decision Jan 26, 1994
Classifications
1
FEI Numbers
94
Registration Numbers
94
Same Product Code
152
Applicant Total
217
Review Days
50
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Basic Information
- Device Name
- ARGELOY PARTIAL (NON-PRECIOUS)
- K Number
- K935829
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 872.3710
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Argen Precious Metals, Inc.
- Date Received
- December 7, 1993
- Decision Date
- January 26, 1994
- Product Code
- EJH
- 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 |
|---|---|---|---|
| EJH | Alloy, Metal, Base | FDA class 2 | Dental |
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Other Clearances by Argen Precious Metals, Inc.
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|---|---|---|---|
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| K961211 | ARGELITE 52+ | Apr 25, 1996 | Substantially Equivalent |
| K961285 | ARGEDENT 40(GOLD-PALLADIUM-SILVER ALLOY FOR PORCELAIN APPLICATION) | Apr 18, 1996 | Substantially Equivalent |
| K954362 | ARGISTAR 74 | Oct 12, 1995 | Substantially Equivalent |
| K954368 | ARGEDENT BIO 87 PF | Oct 7, 1995 | Substantially Equivalent |
| K954358 | ARGENDENT GIO 86 FR | Oct 7, 1995 | Substantially Equivalent |
| K954404 | AUROLITE 45 | Oct 7, 1995 | Substantially Equivalent |
| K954360 | ARGESOL 600 | Oct 7, 1995 | Substantially Equivalent |
| K954371 | SUREFIRE S | Oct 7, 1995 | Substantially Equivalent |