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Cerabien™ Zr 104-5951KA

by Kuraray Noritake Dental Inc.

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

None found

in data synced 22 Oct 2026

Documents

None

No authorization documents

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 NumberEKUR1045951KA0 UDI-DI Date12 Jan 2026ListedStatusListed GUDID: in commercial distribution

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  • Withdrawn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 — GUDID listing Listed

Specification

GUDID

Trade Name
Cerabien™ Zr
Generic Name
Dental appliance fabrication material, ceramic
Model / Reference
104-5951KA
Primary DI / UDI-DI
EKUR1045951KA0
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

Related devices

Cleared under the same submission (K170834)

Show all (12)

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Properties

  • Prescription Use
  • Lot / Batch Number
  • Expiration Date

Other properties (11)

  • Sterile: 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