KATANA Cleaner, KATANA Cleaner (Trial)
FDA 510(k) clearance K191133 · decided 2019-10-08
Clearance details
- K-number
- K191133
- Device name
- KATANA Cleaner, KATANA Cleaner (Trial)
- Applicant
- Kuraray Noritake Dental, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2019-04-29
- Decision date
- 2019-10-08
- Days to decision
- 162 days
- Clearance type
- Traditional
- Product code
- PME
- Device class
- 2
- Regulation number
- 872.3260
- Medical specialty
- Dental
- Advisory committee
- Dental
- Location
- Chiyoda-Ku, JP
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Kuraray Noritake Dental
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| CeraClean (K163171) | Bisco, Inc. | 2017-04-14 |
| Resolve 2.0 (K152322) | Denali Corporation | 2015-12-16 |
Recalls involving this device
No recalls on record reference this clearance.