Planmeca ProSensor HD

EUDAMEDFDA UDIFDA 510(k)

Class IIa (EU MDR)

Ref 10037245 Ref 10037245

by Planmeca Oy

Identity

Trade Name: Planmeca ProSensor FDA UDI
Generic Name: Dental digital imaging sensor, intraoral FDA UDI
Device Name: Planmeca ProSensor HD EUDAMED
Planmeca ProSensor, digital intraoral X-ray imaging system, is an accessory to dental intraoral x-ray devices. It is intended for dental radiographic examination and diagnosis of diseases of the teeth, jaw, and oral structures. FDA UDI
Model / Reference: 10037245 EUDAMED
ProSensor HD FDA UDI
Description: Planmeca ProSensor, digital intraoral X-ray imaging system, is an accessory to dental intraoral x-ray devices. It is intended for dental radiographic examination and diagnosis of diseases of the teeth, jaw, and oral structures. FDA UDI

Identifiers

Catalog Number: 10037245 FDA UDI
Primary DI / UDI-DI: 06430035420308 EUDAMEDFDA UDI
Basic UDI-DI: B-06430035420308 EUDAMED
6430035420085T EUDAMED
510(k) Number: K091197 FDA UDI
FDA Product Code: EHD FDA UDI
EMDN Code: Z1103040102 EQUIPMENT FOR DIGITAL ENDORAL RADIOLOGY EUDAMED
GMDN Term: Dental digital imaging sensor, intraoral FDA UDI

Classification

Device Class: Class IIa EUDAMED
Class II FDA UDI
Regulation Number: 872.1800 FDA UDI
Market of Registration: Finland EUDAMED
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

EUDAMEDFDA UDI

Single Use

FDA UDI

Implantable

EUDAMEDFDA UDI

Reusable

EUDAMED

Contains Latex

EUDAMEDFDA UDI

Reprocessed

EUDAMED

CMR Substance

EUDAMED

Human-derived

EUDAMED

Human Tissues

EUDAMED

Animal Tissues

EUDAMED

Endocrine Disruptor

EUDAMED

Administering Medicine

EUDAMED

Measuring Function

EUDAMED

Incorporates Medicinal Product

EUDAMED

Prescription Use

Yes

FDA UDI

Over-the-Counter

Yes

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Dental digital imaging sensor, intraoral

Planmeca ProSensor HD by Planmeca Oy — Class IIa — MDR, FDA_510K, MDD — listed in EUDAMED, FDA GUDID, FDA 510(k) — regulatory data on deviCERTS

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XIOS XG WIFI — SIRONA DENTAL, INC. · Class II

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

CE/MDR

United States Active

FDA_510K

European Union Active

CE/MDD

Source	Region	Type	Cert / Approval No.	Class	Status
EUDAMED	European Union	CE/MDR	B-06430035420308	Class IIa	Active
FDA 510(k)	United States	FDA_510K	K091197	Class IIa	Active
EUDAMED	European Union	CE/MDD	B-06430035420308	Class IIa	Active

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Manufacturer

Manufacturer: Planmeca Oy
EUDAMED SRN: FI-MF-000006499

Sources (4)

EUDAMED 6b632f8c-f044-4649-baf0-289f887e9764 61 fields · synced Jul 9, 2026
EUDAMED d3962b8b-532b-4fd7-ad3a-8fe7a7fcfd0f 61 fields · synced May 19, 2026
FDA UDI 42893d1f-f7af-43b2-96ee-6704aab0a330 35 fields · synced May 30, 2026
FDA 510(k) K091197 1 fields · synced May 18, 2026