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Zirlux 9011456

by Henry Schein, 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 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing NumberH65890114561 UDI-DI Date24 Sep 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  • Withdrawn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
Zirlux
Generic name
Dental implant abutment analog, intraoral-scanning, single-use
Model / Ref / Catalog
9011456
Primary DI / UDI-DI
H65890114561
FDA product code
NDP
GMDN term
Dental implant abutment analog, intraoral-scanning, single-use
Device class
Class I
Regulation number
872.3980
GUDID distribution status
In Commercial Distribution

Related devices

Category: Dental implant abutment analog, intraoral-scanning, single-use

Other devices from Henry Schein, Inc.

See all devices from Henry Schein, Inc. →

Properties

  • Premarket exempt
  • Lot / batch number
  • Manufacturing date

Other properties (12)

  • Supplied sterile: No
  • Sterilise before use: No
  • Single use: No
  • Implantable: No
  • Contains latex: No
  • Prescription use: No
  • Over-the-counter: No
  • Convenience kit: No
  • Combination product: No
  • HCT/P: No
  • Serial number: No
  • Expiration date: No