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FDA 510(k)

KWIX-BITE X-RAY FILM HOLDER

K-Number: K801079 · 1980-05-20

ApplicantHenry Schein, Inc.
Decision Date1980-05-20
Product CodeEGZ
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

KWIX-BITE X-RAY FILM HOLDER is the device name listed in this FDA 510(k) record. The listed applicant is Henry Schein, Inc.. It received FDA 510(k) clearance on 1980-05-20 under 510(k) number K801079. The device is classified under product code EGZ. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the KWIX-BITE X-RAY FILM HOLDER?

KWIX-BITE X-RAY FILM HOLDER is a medical device that received FDA 510(k) clearance on 1980-05-20. The listed applicant is Henry Schein, Inc.. The 510(k) number is K801079.

When did KWIX-BITE X-RAY FILM HOLDER receive FDA 510(k) clearance?

KWIX-BITE X-RAY FILM HOLDER received FDA 510(k) clearance on 1980-05-20, under 510(k) number K801079.

Who is the listed applicant for KWIX-BITE X-RAY FILM HOLDER?

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

What is the FDA product code for KWIX-BITE X-RAY FILM HOLDER?

The FDA product code for KWIX-BITE X-RAY FILM HOLDER is EGZ.

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Other records listing Henry Schein, Inc. 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.

K041580IMAGERAYIK862384SCHEIN AP-1 AIR POLISHING UNITK862385SCHEIN BLEACHING UNITK841199FIBERGLASS MOUTH MIRRORSK834055VANADIUM EXCAVATORS SIZES 0-6K834056SCHEIN COTTON ROLLS, NON-STERILE

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Related Devices (Code: EGZ)

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.

K913168SALIBAGNix Co. , Ltd.K913160ID-TABNix Co. , Ltd.K890355DENTAL X-RAY BITE BLOCKBite-A-BlockK853451TROLL-BITETrollplast, Inc.K852170EZX YELLOW, BLUE OR ORANGEStrong MarketingK853005S.S. WHITE DENTAL X-RAY FILM HOLDER & ALIGNING ARMThe S. S. White Co.

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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