FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ARGESOL #830Y
K Number: K943212
·
Decision Aug 1, 1994
Classifications
1
FEI Numbers
44
Registration Numbers
44
Same Product Code
626
Applicant Total
217
Review Days
27
Basic Information
- Device Name
- ARGESOL #830Y
- K Number
- K943212
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 872.3060
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- ARGEN PRECIOUS METALS, INC.
- Date Received
- July 5, 1994
- Decision Date
- August 1, 1994
- 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 |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (EJT), ordered by most recent decision date.
PROMETAL HN86
FDA 510(k)
FDA Class 2
·Dental
BIO 60
FDA 510(k)
FDA Class 2
·Dental
PORTA REFLEX
FDA 510(k)
FDA Class 2
·Dental
PORTA SOLDER 1090 W
FDA 510(k)
FDA Class 2
·Dental
NDX-40 ALLOY
FDA 510(k)
FDA Class 2
·Dental
HERADOR EC, PF, C, H, NH, G, GG AND MP; HERALOY U AND G; HERABOND N; ALBABOND C, B AND A; BIO HERANORM
FDA 510(k)
FDA Class 2
·Dental
Other Clearances by ARGEN PRECIOUS METALS, INC.
| K Number | Device Name | ||
|---|---|---|---|
| K965216 | ARGI-SATIN OR OPTI0-STAR | Feb 27, 1997 | Substantially Equivalent |
| K961352 | 285 SL | May 20, 1996 | Substantially Equivalent |
| 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 |
| K954361 | ARGENCO 68M | Oct 7, 1995 | Substantially Equivalent |
| 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 |