510(k) K003635
K003635 is an FDA 510(k) premarket notification submitted by Ivoclar North America, Inc. for the device "DW 276 #3". The FDA issued a decision of Substantially Equivalent on December 22, 2000. The device falls under product code EJT (Alloy, Gold-Based Noble Metal), a Class II device regulated under 21 CFR 872.3060. Ivoclar North America, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 22, 2000
- Date Received
- November 24, 2000
- 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