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HELIODENT Plus

FDA UDI

Class II (US FDA UDI)

by Sirona Dental Systems GmbH

Identity

Trade Name
HELIODENT Plus FDA UDI
Generic Name
Stationary intraoral dental x-ray system, digital FDA UDI
Device Name
HD Plus complete,w/o support arm FDA UDI
Model / Reference
6489632 FDA UDI
Description
HD Plus complete,w/o support arm FDA UDI

Identifiers

Primary DI / UDI-DI
E27664896320 FDA UDI
FDA Product Code
EHD FDA UDI
GMDN Term
Stationary intraoral dental x-ray system, digital FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
872.1800 FDA UDI
Commercial Distribution
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

No

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

Category: Stationary intraoral dental x-ray system, digital

HELIODENT Plus by Sirona Dental Systems GmbH — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Stationary intraoral dental x-ray system, digital.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Sirona Dental Systems GmbH

Sources (1)

  • FDA UDI 3526bcc1-499d-4d84-8650-c4275d405eb0 34 fields · synced Jun 8, 2026