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Zirlux 901-0817

by Henry Schein, Inc.

Zirlux 901-0817 (9010817) is a Class II device made by Henry Schein, Inc., listed in FDA GUDID since 24 Sep 2015 (UDI-DI H65890108170), registry data as of 23 Oct 2026.

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

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing NumberH65890108170 UDI-DI Date24 Sep 2015ListedStatusListed 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  • Withdrawn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
Screw endosteal dental implant, one-piece
Model / Ref / Catalog
901-0817, 9010817
Primary DI / UDI-DI
H65890108170
FDA product code
NHA
GMDN term
Screw endosteal dental implant, one-piece
Device class
Class II
Regulation number
872.3630
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization

Other devices from Henry Schein, Inc.

See all devices from Henry Schein, Inc. →

Properties

  • Sterilise before use
  • Single use
  • Implantable
  • Prescription use
  • Lot / batch number
  • Manufacturing date
Other properties (9, all answered No)