510(k) K863421
K863421 is an FDA 510(k) premarket notification submitted by Ivoclar USA, Inc. for the device "SR-IVOLEN TRAY MATERIAL". The FDA issued a decision of Substantially Equivalent on November 3, 1986. The device falls under product code EBH (Material, Impression Tray, Resin), a Class I device regulated under 21 CFR 872.3670. Ivoclar USA, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- November 3, 1986
- Date Received
- September 4, 1986
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Material, Impression Tray, Resin
- Device Class
- Class I
- Regulation Number
- 872.3670
- Review Panel
- DE
- Submission Type