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HC-Zirkonia Opaltranspa OT2, 20g 66020254

by Kulzer, Inc.

Listed FDA GUDID listing, not in commercial distribution

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 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing NumberJ014660202620 UDI-DI Date15 Sep 2016ListedStatusListed GUDID: not 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  • Withdrawn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
HC-Zirkonia Opaltranspa OT2, 20g
Generic Name
Dental appliance fabrication material, ceramic
Model / Ref / Catalog
66020254
Primary DI / UDI-DI
J014660202620
FDA Product Code
EIH
GMDN Term
Dental appliance fabrication material, ceramic
Device Class
Class II
Regulation Number
872.6660
GUDID distribution status
Not in Commercial Distribution

Other devices from Kulzer, Inc.

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Properties

  • Single Use
  • Prescription Use
  • Lot / Batch Number
  • Manufacturing Date

Other properties (10)

  • Sterile: 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
  • Expiration Date: No