Skip to content

SureSmile® 2000

by Orametrix, Inc.

SureSmile 2000 (ASSY500020) is an orthodontic progressive aligner (FDA Class II; FDA product code NXC, Aligner, sequential) made by Orametrix, Inc., listed in FDA GUDID since 20 May 2026 (UDI-DI 00856379007313), registry data as of 22 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 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00856379007313 UDI-DI Date20 May 2026ListedStatusListed GUDID: in commercial distribution

Official records

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — GUDID listing Listed

Specification

GUDID

Trade name
SureSmile®
Generic name
Orthodontic progressive aligner
Model / Ref / Catalog
2000, ASSY500020
Primary DI / UDI-DI
00856379007313
FDA product code
NXC
GMDN term
Orthodontic progressive aligner
Device class
Class II
Regulation number
872.5470
GUDID distribution status
In Commercial Distribution

Similar devices

Other devices filed under FDA product code NXC (Aligner, sequential).

Other devices from Orametrix, Inc.

See all devices from Orametrix, Inc. →

Properties

  • Single use
  • Prescription use
  • Serial number
  • Manufacturing date
Other properties (11, all answered No)