510(k) K963922
K963922 is an FDA 510(k) premarket notification submitted by Wallace A. Erickson & Co. for the device "ALPHA-DENT ROOT CANAL SEALER & FILLER". The FDA issued a decision of Substantially Equivalent on Dec 6, 1996. The device falls under product code KIF (Resin, Root Canal Filling), a Class II device regulated under 21 CFR 872.3820. Wallace A. Erickson & Co. has 31 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Dec 6, 1996
- Date Received
- Sep 30, 1996
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Resin, Root Canal Filling
- Device Class
- Class II
- Regulation Number
- 872.3820
- Review Panel
- DE
- Submission Type
- 510(k)