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FDA 510(k)

SCHEIN BLEACHING UNIT

K-Number: K862385 · 1986-10-30

ApplicantHenry Schein, Inc.
Decision Date1986-10-30
Product CodeEEG
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

SCHEIN BLEACHING UNIT 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 1986-10-30 under 510(k) number K862385. The device is classified under product code EEG. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SCHEIN BLEACHING UNIT?

SCHEIN BLEACHING UNIT is a medical device that received FDA 510(k) clearance on 1986-10-30. The listed applicant is Henry Schein, Inc.. The 510(k) number is K862385.

When did SCHEIN BLEACHING UNIT receive FDA 510(k) clearance?

SCHEIN BLEACHING UNIT received FDA 510(k) clearance on 1986-10-30, under 510(k) number K862385.

Who is the listed applicant for SCHEIN BLEACHING UNIT?

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 SCHEIN BLEACHING UNIT?

The FDA product code for SCHEIN BLEACHING UNIT is EEG.

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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 UNITK841199FIBERGLASS MOUTH MIRRORSK834055VANADIUM EXCAVATORS SIZES 0-6K834056SCHEIN COTTON ROLLS, NON-STERILEK801079KWIX-BITE X-RAY FILM HOLDER

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Related Devices (Code: EEG)

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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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