KATANA™ Zirconia ONE 125-9634KA
by Kuraray Noritake Dental Inc.
Active
510(k)
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | NumberEKUR1259634KA0 | Date1 Aug 2022 | StatusListed |
| United States | FDA 510(k)SESE | NumberK190436 | Date23 May 2019 | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- KATANA™ Zirconia ONE
- Generic name
- Dental appliance fabrication material, ceramic
- Model / reference
- 125-9634KA
- Primary DI / UDI-DI
- EKUR1259634KA0
- 510(k) Number
- FDA product code
- EIH
- GMDN term
- Dental appliance fabrication material, ceramic
- Device class
- Class II
- Regulation number
- 872.6660
- GUDID distribution status
- In Commercial Distribution
- Size
- Width — 16.5 MillimeterHeight — 19.2 MillimeterLength — 20.2 Millimeter
Other devices from Kuraray Noritake Dental Inc.
Properties
Other properties (12)
- Supplied sterile: No
- Sterilise before use: No
- Single use: No
- Implantable: No
- Contains latex: No
- Over-the-counter: No
- Convenience kit: No
- Combination product: No
- HCT/P: No
- Premarket exempt: No
- Serial number: No
- Manufacturing date: No