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SureSmile Aligner Software 7.6

by Orametrix, Inc.

Ref DIGI-500152

SureSmile Aligner Software 7.6 is a CAD/CAM software (EU MDR Class IIa; FDA Class I; FDA product code EIA, Unit, operative dental) made by Orametrix, Inc., registered in EUDAMED on 13 May 2026 (Basic UDI-DI 0856379007DIGI500CF) and listed in FDA GUDID since 7 Jul 2020 (UDI-DI 00856379007085), active as of 22 Oct 2026.

Active European Union. Also listed in GUDID (US).

CE MDR

Valid until

No date given

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

Source EUDAMED, GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number0856379007DIGI500CF Basic UDI-DI 00856379007085UDI-DIDate13 May 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00856379007085 UDI-DI Date7 Jul 2020ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 0856379007DIGI500CF registered 13 May 2026 Active
  • FDA GUDID UDI-DI 00856379007085 listed 7 Jul 2020 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 00856379007085
  2. Registered EUDAMED 0856379007DIGI500CF

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  • Withdrawn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
SureSmile Aligner Software 7.6 EUDAMED
SureSmile Aligner Software GUDID
Generic name
CAD/CAM software
Device name
SureSmile Software
Model / reference
DIGI-500152 EUDAMED
7.6 GUDID
Primary DI / UDI-DI
00856379007085
Basic UDI-DI
0856379007DIGI500CF
Direct marketing DI
00856379007085
FDA product code
EIA
EMDN code
Z12110182 Instruments for dental treatment units - software accessories
GMDN term
CAD/CAM software
Device class
Class IIa EUDAMED
Class I GUDID
Regulation number
872.6640
Special device type
Software
EU registration type
Standard device
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / referenceEUDAMED
DIGI-500152
GUDID
7.6
Device classEUDAMED
Class IIa
GUDID
Class I

Device class is stated on each registry's own scale: Class IIa in the EU (EUDAMED), Class I in the US (FDA GUDID). EU and US classes are different schemes, so this is not a disagreement.

Related devices

Category: CAD/CAM software

Similar devices in this category

Other devices filed under INSTRUMENTS FOR DENTAL TREATMENT UNITS.

Other devices from Orametrix, Inc.

See all devices from Orametrix, Inc. →

Properties

  • Measuring function
  • Lot / batch number
Other properties (23, all answered No)