The following data is part of a premarket notification filed by Kuraray Noritake Dental Inc. with the FDA for Katana Cleaner, Katana Cleaner (trial).
| Device ID | K191133 |
| 510k Number | K191133 |
| Device Name: | KATANA Cleaner, KATANA Cleaner (Trial) |
| Classification | External Cleaning Solution |
| Applicant | Kuraray Noritake Dental Inc. Ote Center Bldg. 7F Chiyoda-ku, JP 100-0004 |
| Contact | Yasujiro Ohara |
| Correspondent | Yasujiro Ohara Kuraray Noritake Dental Inc. Ote Center Bldg. 7F Chiyoda-ku, JP 100-0004 |
| Product Code | PME |
| CFR Regulation Number | 872.3260 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-04-29 |
| Decision Date | 2019-10-08 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| EKUR003971KA1 | K191133 | 000 |
| EKUR003970KA1 | K191133 | 000 |