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FDA 510(k)

IN EXAM INTRAORAL DENTAL X-RAY SYSTEM

K-Number: K050019 · 2005-01-31

ApplicantKavo America
Decision Date2005-01-31
Product CodeEHD
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

IN EXAM INTRAORAL DENTAL X-RAY SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Kavo America. It received FDA 510(k) clearance on 2005-01-31 under 510(k) number K050019. 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 IN EXAM INTRAORAL DENTAL X-RAY SYSTEM?

IN EXAM INTRAORAL DENTAL X-RAY SYSTEM is a medical device that received FDA 510(k) clearance on 2005-01-31. The listed applicant is Kavo America. The 510(k) number is K050019.

When did IN EXAM INTRAORAL DENTAL X-RAY SYSTEM receive FDA 510(k) clearance?

IN EXAM INTRAORAL DENTAL X-RAY SYSTEM received FDA 510(k) clearance on 2005-01-31, under 510(k) number K050019.

Who is the listed applicant for IN EXAM INTRAORAL DENTAL X-RAY SYSTEM?

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

What is the FDA product code for IN EXAM INTRAORAL DENTAL X-RAY SYSTEM?

The FDA product code for IN EXAM INTRAORAL DENTAL X-RAY SYSTEM is EHD.

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Other records listing Kavo America 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.

K073074KEY LASER III 1243 US WITH DETECTK072262GENTLERAY 980 DIODE LASER SYSTEMK063624KAVO EVEREST C-TEMPK051909DIAGNODENTK030146KAVO KEY LASER 1242 AND KAVO KEY LASER 1243+K032081KAVO EVEREST ZS-BLANK MODELS, 42, 20, AND 60

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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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