FDA 510(k)

SCHEIN AP-1 AIR POLISHING UNIT

K-Number: K862384 · 1986-11-07

Decision Date1986-11-07

Product CodeKOJ

Advisory CommitteeDE

DecisionSubstantially Equivalent

Device Summary

SCHEIN AP-1 AIR POLISHING 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 1986-11-07 under 510(k) number K862384. The device is classified under product code KOJ. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SCHEIN AP-1 AIR POLISHING UNIT?

SCHEIN AP-1 AIR POLISHING UNIT is a medical device that received FDA 510(k) clearance on 1986-11-07. The listed applicant is Henry Schein, Inc.. The 510(k) number is K862384.

When did SCHEIN AP-1 AIR POLISHING UNIT receive FDA 510(k) clearance?

SCHEIN AP-1 AIR POLISHING UNIT received FDA 510(k) clearance on 1986-11-07, under 510(k) number K862384.

Who is the listed applicant for SCHEIN AP-1 AIR POLISHING 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 AP-1 AIR POLISHING UNIT?

The FDA product code for SCHEIN AP-1 AIR POLISHING UNIT is KOJ.

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Other records listing Henry Schein, Inc. as applicant

K041580IMAGERAYI K862385SCHEIN BLEACHING UNIT K841199FIBERGLASS MOUTH MIRRORS K834055VANADIUM EXCAVATORS SIZES 0-6 K834056SCHEIN COTTON ROLLS, NON-STERILE K801079KWIX-BITE X-RAY FILM HOLDER

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Related Devices (Code: KOJ)

K251425turbodent touchMectron S.P.A.K063236BETA-POWDERBrainbase Corporation K042872RONDOFLEX PLUS 360Kavo America Corporation K033675PROSMILE AIR POLISHER AND PROPHYLAXIS POWDERSirona Dental Systems GmbH K033215PREPAIRDanville Materials, Inc.K024105VELOPEX AQUACUT FLUID ABRASION UNITVelopex International, 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.