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FDA 510(k)

HELIODENT PLUS

K-Number: K083344 · 2008-12-23

ApplicantSirona Dental Systems GmbH
Decision Date2008-12-23
Product CodeEHD
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

HELIODENT PLUS is the device name listed in this FDA 510(k) record. The listed applicant is Sirona Dental Systems GmbH. It received FDA 510(k) clearance on 2008-12-23 under 510(k) number K083344. The device is classified under product code EHD. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HELIODENT PLUS?

HELIODENT PLUS is a medical device that received FDA 510(k) clearance on 2008-12-23. The listed applicant is Sirona Dental Systems GmbH. The 510(k) number is K083344.

When did HELIODENT PLUS receive FDA 510(k) clearance?

HELIODENT PLUS received FDA 510(k) clearance on 2008-12-23, under 510(k) number K083344.

Who is the listed applicant for HELIODENT PLUS?

The FDA 510(k) record lists Sirona Dental Systems GmbH as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for HELIODENT PLUS?

The FDA product code for HELIODENT PLUS is EHD.

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Other records listing Sirona Dental Systems GmbH as applicant

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Related Devices (Code: EHD)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K260795Hand-held Dental X-ray System (HyperLight-M)Changzhou Sifary Medical Technology Co., Ltd.K260367Portable Dental X-ray System Model PDX novaPDX Co., Ltd.K253864NOMAD Pro 3Dental Imaging Technologies CorporationK252110Dental X-RAY Unit (AJX200)Guangzhou Ajax Medical Equipment Co., Ltd.K254018Portable Dental X-ray Device (GT-1)Guilin Refine Medical Instrument Co., Ltd.K252909Diagnostic X-Ray Equipment Model POCT22Ningbo Runyes Medical Instrument Co., Ltd.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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