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Temrex Rite Bite Tray 620, 640, 680

by Temrex Corp.

Temrex Rite Bite Tray 620, 640, 680 is a Class I device made by Temrex Corp., listed in FDA GUDID since 9 Mar 2022 (UDI-DI 00850015110535), 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 Number00850015110535 UDI-DI Date9 Mar 2022ListedStatusListed 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  • Withdrawn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
Temrex Rite Bite Tray
Generic name
Dental impression material kit, single-use
Model / reference
620, 640, 680
Primary DI / UDI-DI
00850015110535
FDA product code
EHY
GMDN term
Dental impression material kit, single-use
Device class
Class I
Regulation number
872.6880
GUDID distribution status
In Commercial Distribution

Related devices

Category: Dental impression material kit, single-use

Similar devices

Other devices filed under FDA product code EHY (Tray, Impression, Preformed).

Other devices from Temrex Corp.

See all devices from Temrex Corp. →

Properties

  • Single use
  • Premarket exempt
Other properties (13, all answered No)