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KATANA Bonding Kit #3395-KA

by Kuraray Noritake Dental Inc.

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

Not checked

No FDA submission to match recalls against

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 NumberEKUR003395KA1 UDI-DI Date25 Jul 2018ListedStatusListed GUDID: in commercial distribution

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Trade Name
KATANA Bonding Kit
Generic Name
Dentine bonding agent/set
Model / Reference
#3395-KA
Primary DI / UDI-DI
EKUR003395KA1
FDA Product Code
KLE, EMA
GMDN Term
Dentine bonding agent/set
Device Class
Class II
Regulation Number
872.3200, 872.3275
GUDID distribution status
In Commercial Distribution

Related devices

Category: Dental composite resinDentine bonding agent/set

Other devices from Kuraray Noritake Dental Inc.

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Properties

  • Prescription Use
  • Convenience Kit
  • Lot / Batch Number
  • Expiration Date

Other properties (10)

  • Sterile: No
  • Single Use: No
  • Implantable: No
  • Contains Latex: No
  • Over-the-Counter: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No
  • Manufacturing Date: No