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SIMPLANT® Version 2

by Dentsply Implants NV 2 variants

SIMPLANT® Version 2 (54500394E2) is a Class II device made by Dentsply Implants NV, listed in FDA GUDID since 30 Sep 2016 (UDI-DI 07392532181252), 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 Number07392532181252 UDI-DI Date30 Sep 2016ListedStatusListed 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  • Withdrawn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
Simplant®
Generic name
Panoramic/tomographic dental x-ray system application software
Model / Ref / Catalog
Version 2, 54500394E2
Primary DI / UDI-DI
07392532181252
FDA product code
LLZ
GMDN term
Panoramic/tomographic dental x-ray system application software
Device class
Class II
Regulation number
892.2050
GUDID distribution status
In Commercial Distribution

Related devices

Category: Panoramic/tomographic dental x-ray system application software

Similar devices

Other devices filed under FDA product code LLZ (System, image processing, radiological).

Other devices from Dentsply Implants NV

See all devices from Dentsply Implants NV →

Properties

  • Prescription use
Other properties (14, all answered No)