510(k) K010250
K010250 is an FDA 510(k) premarket notification submitted by Ivoclar North America, Inc. for the device "TETRIC CERAM HB". The FDA issued a decision of Substantially Equivalent on February 28, 2001. The device falls under product code EBF (Material, Tooth Shade, Resin), a Class II device regulated under 21 CFR 872.3690. Ivoclar North America, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 28, 2001
- Date Received
- January 26, 2001
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Material, Tooth Shade, Resin
- Device Class
- Class II
- Regulation Number
- 872.3690
- Review Panel
- DE
- Submission Type