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FDA 510(k)

DEXIS MODEL 601 DENTAL ELECTRONIC IMAGING SYSTEM

K-Number: K962631 · 1996-11-26

ApplicantFair Image, Inc.
Decision Date1996-11-26
Product CodeEHD
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

DEXIS MODEL 601 DENTAL ELECTRONIC IMAGING SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Fair Image, Inc.. It received FDA 510(k) clearance on 1996-11-26 under 510(k) number K962631. 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 DEXIS MODEL 601 DENTAL ELECTRONIC IMAGING SYSTEM?

DEXIS MODEL 601 DENTAL ELECTRONIC IMAGING SYSTEM is a medical device that received FDA 510(k) clearance on 1996-11-26. The listed applicant is Fair Image, Inc.. The 510(k) number is K962631.

When did DEXIS MODEL 601 DENTAL ELECTRONIC IMAGING SYSTEM receive FDA 510(k) clearance?

DEXIS MODEL 601 DENTAL ELECTRONIC IMAGING SYSTEM received FDA 510(k) clearance on 1996-11-26, under 510(k) number K962631.

Who is the listed applicant for DEXIS MODEL 601 DENTAL ELECTRONIC IMAGING SYSTEM?

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

What is the FDA product code for DEXIS MODEL 601 DENTAL ELECTRONIC IMAGING SYSTEM?

The FDA product code for DEXIS MODEL 601 DENTAL ELECTRONIC IMAGING SYSTEM 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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