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FDA 510(k)

DENTAL X-RAY UNIT HELIODENT 70

K-Number: K781288 · 1978-09-11

ApplicantSiemens Corp.
Decision Date1978-09-11
Product CodeEHD
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

DENTAL X-RAY UNIT HELIODENT 70 is the device name listed in this FDA 510(k) record. The listed applicant is Siemens Corp.. It received FDA 510(k) clearance on 1978-09-11 under 510(k) number K781288. 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 DENTAL X-RAY UNIT HELIODENT 70?

DENTAL X-RAY UNIT HELIODENT 70 is a medical device that received FDA 510(k) clearance on 1978-09-11. The listed applicant is Siemens Corp.. The 510(k) number is K781288.

When did DENTAL X-RAY UNIT HELIODENT 70 receive FDA 510(k) clearance?

DENTAL X-RAY UNIT HELIODENT 70 received FDA 510(k) clearance on 1978-09-11, under 510(k) number K781288.

Who is the listed applicant for DENTAL X-RAY UNIT HELIODENT 70?

The FDA 510(k) record lists Siemens Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for DENTAL X-RAY UNIT HELIODENT 70?

The FDA product code for DENTAL X-RAY UNIT HELIODENT 70 is EHD.

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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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