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Orthosource 1002K-10

by Ortho Source

Orthosource 1002K-10 is a Class I device made by Ortho Source, listed in FDA GUDID since 26 Oct 2022 (UDI-DI D9111002K100), 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 NumberD9111002K100 UDI-DI Date26 Oct 2022ListedStatusListed GUDID: in commercial distribution

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Trade name
Orthosource
Generic name
Orthodontic palate expander/teeth aligner, self-removable
Model / reference
1002K-10
Primary DI / UDI-DI
D9111002K100
FDA product code
DYJ
GMDN term
Orthodontic palate expander/teeth aligner, self-removable
Device class
Class I
Regulation number
872.5410
GUDID distribution status
In Commercial Distribution

Related devices

Category: Orthodontic palate expander/teeth aligner, self-removable

Similar devices

Other devices filed under FDA product code DYJ (Retainer, Screw Expansion, Orthodontic).

Other devices from Ortho Source

See all devices from Ortho Source →

Properties

  • Single use
  • Premarket exempt
  • Lot / batch number
  • Expiration date
Other properties (11, all answered No)