510(k) K965216
K965216 is an FDA 510(k) premarket notification submitted by Argen Precious Metals, Inc. for the device "ARGI-SATIN OR OPTI0-STAR". The FDA issued a decision of Substantially Equivalent on February 27, 1997. The device falls under product code ELL (Teeth, Porcelain), a Class II device regulated under 21 CFR 872.3920. Argen Precious Metals, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 27, 1997
- Date Received
- December 30, 1996
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Teeth, Porcelain
- Device Class
- Class II
- Regulation Number
- 872.3920
- Review Panel
- DE
- Submission Type