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FDA 510(k)

FIBERGLASS MOUTH MIRRORS

K-Number: K841199 · 1984-04-25

ApplicantHenry Schein, Inc.
Decision Date1984-04-25
Product CodeEAX
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

FIBERGLASS MOUTH MIRRORS 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 1984-04-25 under 510(k) number K841199. The device is classified under product code EAX. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the FIBERGLASS MOUTH MIRRORS?

FIBERGLASS MOUTH MIRRORS is a medical device that received FDA 510(k) clearance on 1984-04-25. The listed applicant is Henry Schein, Inc.. The 510(k) number is K841199.

When did FIBERGLASS MOUTH MIRRORS receive FDA 510(k) clearance?

FIBERGLASS MOUTH MIRRORS received FDA 510(k) clearance on 1984-04-25, under 510(k) number K841199.

Who is the listed applicant for FIBERGLASS MOUTH MIRRORS?

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 FIBERGLASS MOUTH MIRRORS?

The FDA product code for FIBERGLASS MOUTH MIRRORS is EAX.

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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 UNITK834055VANADIUM EXCAVATORS SIZES 0-6K834056SCHEIN COTTON ROLLS, NON-STERILEK801079KWIX-BITE X-RAY FILM HOLDER

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Related Devices (Code: EAX)

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.

K946073ORALVUE DENTAL MIRRORHines Group , Ltd.K935906RANIR PLAX RXRanir/Dcp Corp.K941574RETRO MIRRORUnion Broach, Div. Moyco Industries, Inc.K935687NILDentalsafe Systems Pty., Ltd.K863767GLASS MOUTH MIRRORS, REUSABLEThe Medical Group, Inc.K863766DISPOSABLE MOUTH MIRRORS, SINGLE USE ONLYThe Medical Group, Inc.

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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