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Essix A+ 11040-SH

by Dentsply Sirona Orthodontics 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 NumberD74611040SH1 UDI-DI Date24 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  • Withdrawn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
Essix A+
Generic Name
Dental appliance fabrication material, thermoplastic
Model / Ref / Catalog
11040-SH
Primary DI / UDI-DI
D74611040SH1
FDA Product Code
NXC, EBG, MQC, KMY
GMDN Term
Dental appliance fabrication material, thermoplastic
Device Class
Class II
Regulation Number
872.5470, 872.3770, 872.5525
GUDID distribution status
Not in Commercial Distribution

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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