510(k) K014082
K014082 is an FDA 510(k) premarket notification submitted by Ivoclar Vivadent, Inc. for the device "D.SIGN 53, MODEL NA1012204". The FDA issued a decision of Substantially Equivalent on January 30, 2002. The device falls under product code EJS (Alloy, Other Noble Metal), a Class II device regulated under 21 CFR 872.3060. Ivoclar Vivadent, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 30, 2002
- Date Received
- December 11, 2001
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Alloy, Other Noble Metal
- Device Class
- Class II
- Regulation Number
- 872.3060
- Review Panel
- DE
- Submission Type