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Planmeca ProMax ProMax 3D Max

by Planmeca Oy 3 variants

Planmeca ProMax ProMax 3D Max (30003115) is a Class II device made by Planmeca Oy, listed in FDA GUDID since 19 Sep 2016 (UDI-DI 06430035420513), not in commercial distribution (GUDID) as of 22 Oct 2026.

Listed FDA GUDID listing, not in commercial distribution

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 Number06430035420513 UDI-DI Date19 Sep 2016ListedStatusListed GUDID: not 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  • Withdrawn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
Planmeca ProMax
Generic name
Stationary panoramic/tomographic dental x-ray system, digital
Model / Ref / Catalog
ProMax 3D Max, 30003115
Primary DI / UDI-DI
06430035420513
FDA product code
OAS
GMDN term
Stationary panoramic/tomographic dental x-ray system, digital
Device class
Class II
Regulation number
892.1750
GUDID distribution status
Not in Commercial Distribution

Similar devices

Other devices filed under FDA product code OAS (X-Ray, Tomography, Computed, Dental).

Other devices from Planmeca Oy

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Properties

  • Prescription use
  • Over-the-counter
  • Serial number
  • Manufacturing date
Other properties (11, all answered No)