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FDA 510(k)

PORTABLE HDX INTRAORAL X-RAY

K-Number: K021378 · 2002-06-07

ApplicantDentalez Group
Decision Date2002-06-07
Product CodeEHD
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

PORTABLE HDX INTRAORAL X-RAY is the device name listed in this FDA 510(k) record. The listed applicant is Dentalez Group. It received FDA 510(k) clearance on 2002-06-07 under 510(k) number K021378. 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 PORTABLE HDX INTRAORAL X-RAY?

PORTABLE HDX INTRAORAL X-RAY is a medical device that received FDA 510(k) clearance on 2002-06-07. The listed applicant is Dentalez Group. The 510(k) number is K021378.

When did PORTABLE HDX INTRAORAL X-RAY receive FDA 510(k) clearance?

PORTABLE HDX INTRAORAL X-RAY received FDA 510(k) clearance on 2002-06-07, under 510(k) number K021378.

Who is the listed applicant for PORTABLE HDX INTRAORAL X-RAY?

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

What is the FDA product code for PORTABLE HDX INTRAORAL X-RAY?

The FDA product code for PORTABLE HDX INTRAORAL X-RAY is EHD.

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Other records listing Dentalez Group 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.

K030133SOLARA SERIES COMPRISED OF THE SOLARA HIGH SPEED DENTAL HANDPIECE AND THE SOLARA PLUS HIGH SPEED DENTAL HANDPIECEK990844STARDENTAL AXCS STERILE WATER SYSTEMK983574STARDENTAL TITAN 3 LUBEFREE MOTOR ATTACHMENTSK982593LUBE FREE AUTOCHUCK TURBINE WITH VORTEX AIR SEAL FOR USE WITH STAR DENTAL 430 SERIES LUBE FREE HIGH SPEED DENTAL HANDPIEK960719STAR DENTAL 430 SERIES HIGH SPEED HANDPIECEK960260STAR TITAN SERIES MOTORS & ATTACHMENTS

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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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