510(k) K923926
K923926 is an FDA 510(k) premarket notification submitted by Ivoclar North America, Inc. for the device "IPS CERAMIC ETCHING GEL". The FDA issued a decision of Substantially Equivalent on October 27, 1992. The device falls under product code ELL (Teeth, Porcelain), a Class II device regulated under 21 CFR 872.3920. Ivoclar North America, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 27, 1992
- Date Received
- August 5, 1992
- 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