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Essix ACE 1A425-SH

by Dentsply Sirona Orthodontics Inc.

Active European Union. Also listed in GUDID (US), not in commercial distribution.

CE MDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, GUDID, synced 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing GUDID NumberD7461A425SH1 UDI-DI Date24 Sep 2016ListedStatusListed GUDID: not in commercial distribution
European UnionCE/MDR EUDAMED Number— Date—StatusActive

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States GUDID listing Listed

Specification

EUDAMED · GUDID

Trade Name
Essix ACE
Generic Name
Dental appliance fabrication material, thermoplastic
Model / Ref / Catalog
1A425-SH
Primary DI / UDI-DI
D7461A425SH1
FDA Product Code
MQC, NXC, EBG, KMY
GMDN Term
Dental appliance fabrication material, thermoplastic
Device Class
U
Regulation Number
872.5470, 872.3770, 872.5525
GUDID distribution status
Not in Commercial Distribution

Other devices from Dentsply Sirona Orthodontics Inc.

See all devices from Dentsply Sirona Orthodontics Inc. →

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