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Planmeca ProMax ProMax 3D

by Planmeca Oy 3 variants

Planmeca ProMax ProMax 3D (30016945) is a Class II device made by Planmeca Oy, cleared under FDA 510(k) K060328 on 15 Mar 2006 and listed in FDA GUDID since 19 Sep 2016 (UDI-DI 06430035420469), active (FDA 510(k)), not in commercial distribution (GUDID) as of 22 Oct 2026.

Active United States. Also listed in GUDID (US), not in commercial distribution.

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

510(k) K060328

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number06430035420469 UDI-DI Date19 Sep 2016ListedStatusListed GUDID: not in commercial distribution
United StatesFDA 510(k) from GUDID NumberK060328 Date15 Mar 2006IssuedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K060328 decided 15 Mar 2006 Active
  • FDA GUDID UDI-DI 06430035420469 listed 19 Sep 2016 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K060328
  2. Listed FDA GUDID 06430035420469

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Planmeca ProMax
Generic name
Stationary panoramic/tomographic dental x-ray system, digital
Model / Ref / Catalog
ProMax 3D, 30016945
Primary DI / UDI-DI
06430035420469
510(k) Number
FDA product code
MUH
GMDN term
Stationary panoramic/tomographic dental x-ray system, digital
Device class
Class II
Regulation number
872.1800
GUDID distribution status
Not in Commercial Distribution

Related devices

Cleared under the same submission (K060328)

Similar devices

Other devices filed under FDA product code MUH (System,X-Ray,Extraoral Source,Digital).

Other devices from Planmeca Oy

See all devices from Planmeca Oy →

Properties

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