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Ose X009-008

by Orthodontic Supply & Equipment Co., Inc.

Ose X009-008 is a Class I device made by Orthodontic Supply & Equipment Co., Inc., listed in FDA GUDID since 26 Nov 2025 (UDI-DI 00810042124868), 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 Number00810042124868 UDI-DI Date26 Nov 2025ListedStatusListed 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  • Withdrawn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
Ose
Generic name
Dental cheek retractor, professional, single-use
Model / reference
X009-008
Primary DI / UDI-DI
00810042124868
FDA product code
EIG
GMDN term
Dental cheek retractor, professional, single-use
Device class
Class I
Regulation number
872.4565
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization

Other devices from Orthodontic Supply & Equipment Co., Inc.

See all devices from Orthodontic Supply & Equipment Co., Inc. →

Properties

  • Sterilise before use
  • Premarket exempt
  • Lot / batch number
Other properties (12, all answered No)