510(k) K191133
K191133 is an FDA 510(k) premarket notification submitted by Kuraray Noritake Dental, Inc. for the device "KATANA Cleaner, KATANA Cleaner (Trial)". The FDA issued a decision of Substantially Equivalent on October 8, 2019. The device falls under product code PME (External Cleaning Solution), a Class II device regulated under 21 CFR 872.3260. Kuraray Noritake Dental, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 8, 2019
- Date Received
- April 29, 2019
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- External Cleaning Solution
- Device Class
- Class II
- Regulation Number
- 872.3260
- Review Panel
- DE
- Submission Type
For use on dental restorations, external to the mouth, prior to insertion into the mouth.