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KATANA™ Zirconia ONE 125-9696KA

by Kuraray Noritake Dental Inc.

Active United States. Also listed in GUDID (US).

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

510(k) K233285

FDA submission, from GUDID

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source GUDID, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing NumberEKUR1259696KA0 UDI-DI Date21 Nov 2024ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK233285 Date24 May 2024DecidedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

GUDID

Trade name
KATANA™ Zirconia ONE
Generic name
Dental appliance fabrication material, ceramic
Model / reference
125-9696KA
Primary DI / UDI-DI
EKUR1259696KA0
510(k) Number
FDA product code
NHA
GMDN term
Dental appliance fabrication material, ceramic
Device class
Class II
Regulation number
872.3630
GUDID distribution status
In Commercial Distribution
MRI safety
MR Conditional

Related devices

Category: Dental appliance fabrication material, ceramic

Cleared under the same submission (K233285)

Show all (12)

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Properties

  • Prescription use
  • Lot / batch number
  • Expiration date

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