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Planmeca ProMax

FDA UDI

Class II (US FDA UDI)

by Planmeca Oy

Identity

Trade Name
Planmeca ProMax FDA UDI
Generic Name
Stationary panoramic/tomographic dental x-ray system, digital FDA UDI
Device Name
Planmeca ProMax 3D, is a three dimensional Cone Beam Computed Tomography (CBCT) x-ray system, which is intended for dental radiographic examination and diagnosis of diseases of the teeth, jaw, and oral structures. FDA UDI
Model / Reference
ProMax 3D FDA UDI
Description
Planmeca ProMax 3D, is a three dimensional Cone Beam Computed Tomography (CBCT) x-ray system, which is intended for dental radiographic examination and diagnosis of diseases of the teeth, jaw, and oral structures. FDA UDI

Identifiers

Catalog Number
30016945 FDA UDI
Primary DI / UDI-DI
06430035420469 FDA UDI
510(k) Number
K060328 FDA UDI
FDA Product Code
MUH FDA UDI
GMDN Term
Stationary panoramic/tomographic dental x-ray system, digital FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
872.1800 FDA UDI
Commercial Distribution
Not in Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

Yes

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI

Planmeca ProMax by Planmeca Oy — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Cleared under the same submission

K060328 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Planmeca Oy

Sources (1)

  • FDA UDI 41afbb91-da16-4aec-bb5f-5cf71b504051 36 fields · synced May 30, 2026