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Planmeca Romexis

EUDAMEDFDA UDIFDA 510(k)

Class IIb (EU MDR)

Ref 30004340

by Planmeca Oy

Identity

Trade Name
Planmeca Romexis FDA UDI
Generic Name
Panoramic/tomographic dental x-ray system application software FDA UDI
Device Name
Planmeca Romexis EUDAMED
Planmeca Romexis is a modular imaging software for dental and medical use. FDA UDI
Model / Reference
30004340 EUDAMED
6 FDA UDI
Description
Planmeca Romexis is a modular imaging software for dental and medical use. FDA UDI

Identifiers

Catalog Number
10041546 FDA UDI
Primary DI / UDI-DI
06430035420599 EUDAMEDFDA UDI
Basic UDI-DI
B-06430035420599 EUDAMED
6430035420185W EUDAMED
510(k) Number
K200572 FDA UDI
FDA Product Code
LLZ FDA UDI
EMDN Code
Z11030382 INSTRUMENTS FOR EXTRAORAL DENTAL RADIOLOGY - SOFTWARE ACCESSORIES EUDAMED
GMDN Term
Panoramic/tomographic dental x-ray system application software FDA UDI

Classification

Device Class
Class IIb EUDAMED
Class II FDA UDI
Regulation Number
892.2050 FDA UDI
Special Device Type
-1192 EUDAMED
Software EUDAMED
Market of Registration
Finland EUDAMED
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

EUDAMEDFDA UDI

Single Use

No

FDA UDI

Implantable

No

EUDAMEDFDA UDI

Reusable

No

EUDAMED

Contains Latex

No

EUDAMEDFDA UDI

Reprocessed

No

EUDAMED

CMR Substance

No

EUDAMED

Human-derived

No

EUDAMED

Human Tissues

No

EUDAMED

Animal Tissues

No

EUDAMED

Endocrine Disruptor

No

EUDAMED

Administering Medicine

No

EUDAMED

Measuring Function

Yes

EUDAMED

Incorporates Medicinal Product

No

EUDAMED

Prescription Use

No

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

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI

The Planmeca Romexis is a digital dental imaging system (Nomenclature Code: Z11030382), designed for intraoral and extraoral radiographic imaging in dental diagnostics. It provides high-resolution imaging for assessing teeth, jaw structures, and surrounding anatomy, supporting comprehensive dental assessments and treatment planning.

This system is supplied as a non-sterile, non-reusable device (Sterile: 0, Reusable: 0) and is intended for use in dental clinics and oral healthcare settings. It is classified as Class IIb under medical device regulations, with FDA 510K, MDD, and MDR authorisations. The device includes a Basic UDI (B-06430035420599) for traceability and does not contain latex or animal-derived components.

Frequently asked questions

What types of dental imaging can the Planmeca Romexis perform, and how does this benefit dental diagnostics?

The Planmeca Romexis is designed for both intraoral and extraoral radiographic imaging, allowing it to capture detailed images of teeth, jaw structures, and surrounding anatomy. This versatility supports comprehensive dental assessments, including diagnosing cavities, evaluating bone structure, and planning treatments like implants or orthodontics, by providing high-resolution visualizations critical for accurate diagnosis and treatment planning.

Is the Planmeca Romexis intended for single-use or repeated use in a clinical setting, and what does this mean for maintenance?

The Planmeca Romexis is explicitly labeled as a non-reusable device, meaning it is not designed for reprocessing or reuse after a single use cycle. This classification simplifies maintenance protocols, as it eliminates the need for sterilization or cleaning between patients, reducing operational complexity and potential contamination risks in dental clinics.

Does the Planmeca Romexis contain any materials that could pose allergies or compatibility issues for patients, and how does this affect its use?

The Planmeca Romexis does not contain latex or animal-derived components, which helps minimize the risk of allergic reactions or sensitivities in patients. This makes it a safer choice for clinicians managing patients with known latex allergies or ethical concerns about animal-derived materials, ensuring broader compatibility across diverse patient populations.

How can I verify the authenticity and traceability of the Planmeca Romexis device I purchase?

The Planmeca Romexis includes a Basic UDI (B-06430035420599) for traceability, allowing you to verify its authenticity and origin through the assigned UDI database. This ensures you are acquiring a genuine, authorized product and can track its regulatory compliance, which is particularly useful for inventory management and audit purposes in dental clinics.

What regulatory pathways has the Planmeca Romexis followed, and what does this mean for its use in different markets?

The Planmeca Romexis has obtained FDA 510K clearance, MDD (Medical Device Directive), and MDR (Medical Device Regulation) authorizations, indicating it meets stringent safety and performance standards in the U.S., EU, and other regions following MDR compliance. This multi-market approval streamlines procurement for international clinics, ensuring the device can be legally used across these jurisdictions without additional local validation.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them.

Authorization Coverage (2 countries)

Regulatory Authorizations

United States Active

FDA_510K

United States Active

FDA_510K

United States Active

FDA_510K

European Union Active

CE/MDR

European Union Active

CE/MDD

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Planmeca Oy
EUDAMED SRN
FI-MF-000006499

Sources (4)

  • EUDAMED e523cdf0-ac32-4263-9f8c-8843fd593d03 61 fields · synced Sep 18, 2026
  • EUDAMED b40c9538-6606-4d94-ab19-81358a1522f5 61 fields · synced May 17, 2026
  • FDA UDI 82def1a7-f6d8-4657-b02d-1ce2d1395388 35 fields · synced May 30, 2026
  • FDA 510(k) K200572 1 fields · synced May 18, 2026