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Onegloss 0186

by Shofu Dental Corp.

Onegloss 0186 is a Class I device made by Shofu Dental Corp., listed in FDA GUDID since 3 Feb 2021 (UDI-DI E23501860), 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 NumberE23501860 UDI-DI Date3 Feb 2021ListedStatusListed 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  • Withdrawn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
Onegloss
Generic name
Dental polishing cup, single-use
Model / Ref / Catalog
0186
Primary DI / UDI-DI
E23501860
FDA product code
EHL
GMDN term
Dental polishing cup, single-use
Device class
Class I
Regulation number
872.6010
GUDID distribution status
In Commercial Distribution

Related devices

Category: Dental polishing cup, single-use

Other devices from Shofu Dental Corp.

See all devices from Shofu Dental Corp. →

Properties

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