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UltraPro Tx 8341

by Ultradent Products, Inc.

UltraPro Tx 8341 is a dental polishing cup (FDA Class I; FDA product code EHK, Cup, Prophylaxis) made by Ultradent Products, Inc., listed in FDA GUDID since 31 Jul 2018 (UDI-DI 00883205026132), registry data as of 23 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 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00883205026132 UDI-DI Date31 Jul 2018ListedStatusListed 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  • Withdrawn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
UltraPro Tx
Generic name
Dental polishing cup, reusable
Model / Ref / Catalog
8341
Primary DI / UDI-DI
00883205026132
FDA product code
EHK
GMDN term
Dental polishing cup, reusable
Device class
Class I
Regulation number
872.6290
GUDID distribution status
In Commercial Distribution

Related devices

Category: Dental polishing cup, reusable

Similar devices

Other devices filed under FDA product code EHK (CUP, PROPHYLAXIS).

Other devices from Ultradent Products, Inc.

See all devices from Ultradent Products, Inc. →

Properties

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