510(k) K961285
K961285 is an FDA 510(k) premarket notification submitted by Argen Precious Metals, Inc. for the device "ARGEDENT 40(GOLD-PALLADIUM-SILVER ALLOY FOR PORCELAIN APPLICATION)". The FDA issued a decision of Substantially Equivalent on Apr 18, 1996. The device falls under product code EJT (Alloy, Gold-Based Noble Metal), a Class II device regulated under 21 CFR 872.3060. Argen Precious Metals, Inc. has 216 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Apr 18, 1996
- Date Received
- Apr 3, 1996
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Alloy, Gold-Based Noble Metal
- Device Class
- Class II
- Regulation Number
- 872.3060
- Review Panel
- DE
- Submission Type
- 510(k) Exempt