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FDA 510(k)

DIGIREX DIGITAL DENTAL RADIOGRAPHY SYSTEM

K-Number: K060640 · 2006-04-24

ApplicantDentamerica
Decision Date2006-04-24
Product CodeEHD
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

DIGIREX DIGITAL DENTAL RADIOGRAPHY SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Dentamerica. It received FDA 510(k) clearance on 2006-04-24 under 510(k) number K060640. 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 DIGIREX DIGITAL DENTAL RADIOGRAPHY SYSTEM?

DIGIREX DIGITAL DENTAL RADIOGRAPHY SYSTEM is a medical device that received FDA 510(k) clearance on 2006-04-24. The listed applicant is Dentamerica. The 510(k) number is K060640.

When did DIGIREX DIGITAL DENTAL RADIOGRAPHY SYSTEM receive FDA 510(k) clearance?

DIGIREX DIGITAL DENTAL RADIOGRAPHY SYSTEM received FDA 510(k) clearance on 2006-04-24, under 510(k) number K060640.

Who is the listed applicant for DIGIREX DIGITAL DENTAL RADIOGRAPHY SYSTEM?

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

What is the FDA product code for DIGIREX DIGITAL DENTAL RADIOGRAPHY SYSTEM?

The FDA product code for DIGIREX DIGITAL DENTAL RADIOGRAPHY SYSTEM is EHD.

Related Clinical Trials

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.

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Other records listing Dentamerica 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.

K092833ENDOMAX CORDLESS ENDODONTIC HANDPIECEK954820SCALEX 800K955759LITEX 680

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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