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sureclear aligner 1000

by Orametrix, Inc.

sureclear aligner 1000, an orthodontic progressive aligner (FDA Class II; FDA product code NXC, Aligner, Sequential) made by Orametrix, Inc., was cleared under FDA 510(k) K171860 on 5 Jan 2018 and listed in FDA GUDID on 5 Mar 2018 (UDI-DI 00856379007009); the registry lists it as not in commercial distribution (GUDID) as of 22 Oct 2026.

Active United States. Also listed in GUDID (US), not in commercial distribution.

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

510(k) K171860

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00856379007009 UDI-DI Date5 Mar 2018ListedStatusListed GUDID: not in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK171860 Date5 Jan 2018DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K171860 decided 5 Jan 2018 Active
  • FDA GUDID UDI-DI 00856379007009 listed 5 Mar 2018 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K171860
  2. Listed FDA GUDID 00856379007009

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
sureclear aligner
Generic name
Orthodontic progressive aligner
Model / reference
1000
Primary DI / UDI-DI
00856379007009
510(k) Number
FDA product code
NXC
GMDN term
Orthodontic progressive aligner
Device class
Class II
Regulation number
872.5470
GUDID distribution status
Not 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

  • Prescription use
  • Serial number
  • Manufacturing date
Other properties (12, all answered No)