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FDA 510(k)

ORALIX DC

K-Number: K931001 · 1993-09-14

ApplicantGendex Corp.
Decision Date1993-09-14
Product CodeEHD
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

ORALIX DC is the device name listed in this FDA 510(k) record. The listed applicant is Gendex Corp.. It received FDA 510(k) clearance on 1993-09-14 under 510(k) number K931001. 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 ORALIX DC?

ORALIX DC is a medical device that received FDA 510(k) clearance on 1993-09-14. The listed applicant is Gendex Corp.. The 510(k) number is K931001.

When did ORALIX DC receive FDA 510(k) clearance?

ORALIX DC received FDA 510(k) clearance on 1993-09-14, under 510(k) number K931001.

Who is the listed applicant for ORALIX DC?

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

What is the FDA product code for ORALIX DC?

The FDA product code for ORALIX DC is EHD.

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Other records listing Gendex Corp. as applicant

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.

K952598GX-PAN PANORAMIC DENTAL X-RAY SYSTEMK945682PROCESSOR, RADIOGRAPHIC-FILM, AUTOMATIC, DENTALK935046GX-770 X-RAY CONTROL, MODEL 46-404600G4K925094VISUALIX RADIOGRAPHIC IMAGE DETECTING AND PROCESSK932675GXP DENTAL X-RAY PROCESSORK922165ATC725, ATC525, AND AP300

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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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