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Digirex 105MX

by Dentamerica

Digirex 105MX is a Class II device made by Dentamerica, listed in FDA GUDID since 21 Apr 2026 (UDI-DI 00850461008097), 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 Number00850461008097 UDI-DI Date21 Apr 2026ListedStatusListed 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  • Withdrawn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
Digirex
Generic name
Dental digital imaging sensor, intraoral
Model / reference
105MX
Primary DI / UDI-DI
00850461008097
FDA product code
EHD
GMDN term
Dental digital imaging sensor, intraoral
Device class
Class II
Regulation number
872.1800
GUDID distribution status
In Commercial Distribution

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Properties

Other properties (15, all answered No)