510(k) K901037
K901037 is an FDA 510(k) premarket notification submitted by J. Morita USA, Inc. for the device "VISIONER 21-A". The FDA issued a decision of Substantially Equivalent on August 14, 1990. The device falls under product code EKS (File, Pulp Canal, Endodontic), a Class I device regulated under 21 CFR 872.4565. J. Morita USA, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 14, 1990
- Date Received
- March 6, 1990
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- File, Pulp Canal, Endodontic
- Device Class
- Class I
- Regulation Number
- 872.4565
- Review Panel
- DE
- Submission Type