510(k) K013809
K013809 is an FDA 510(k) premarket notification submitted by Ivoclar Vivadent, Inc. for the device "D.SIGN 59". The FDA issued a decision of Substantially Equivalent on February 7, 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
- February 7, 2002
- Date Received
- November 15, 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