510(k) K830764
K830764 is an FDA 510(k) premarket notification submitted by Shizai Corp. for the device "FR ROOT CANAL SEALER". The FDA issued a decision of Substantially Equivalent on July 26, 1983. The device falls under product code EKA (File, Margin Finishing, Operative), a Class I device regulated under 21 CFR 872.4565. Shizai Corp. has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 26, 1983
- Date Received
- March 10, 1983
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- File, Margin Finishing, Operative
- Device Class
- Class I
- Regulation Number
- 872.4565
- Review Panel
- DE
- Submission Type