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ProMonitoring FGS-2004

by Candid Care Co.

ProMonitoring FGS-2004 is an orthodontic progressive aligner (FDA Class II; FDA product code NXC, Aligner, Sequential) made by Candid Care Co., cleared under FDA 510(k) K190948 on 9 May 2019 and listed in FDA GUDID since 14 Sep 2026 (UDI-DI 00850004223994), active as of 23 Oct 2026.

Active United States. Also listed in GUDID (US).

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 23 Oct 2026

Documents

510(k) K190948

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00850004223994 UDI-DI Date14 Sep 2026ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK190948 Date9 May 2019DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K190948 decided 9 May 2019 Active
  • FDA GUDID UDI-DI 00850004223994 listed 14 Sep 2026 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K190948
  2. Listed FDA GUDID 00850004223994

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
ProMonitoring
Generic name
Orthodontic progressive aligner
Model / reference
FGS-2004
Primary DI / UDI-DI
00850004223994
510(k) Number
FDA product code
NXC
GMDN term
Orthodontic progressive aligner
Device class
Class II
Regulation number
872.5470
GUDID distribution status
In Commercial Distribution

Related devices

Cleared under the same submission (K190948)

and 8 more cleared under K190948

Similar devices

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

Other devices from Candid Care Co.

See all devices from Candid Care Co. →

Properties

  • Single use
  • Prescription use
  • Lot / batch number
  • Serial number
  • Manufacturing date
Other properties (10, all answered No)