Data / Medical devices / United States / Henry Schein Mso, LLC

Henry Schein Mso, LLC: FDA-registered device maker in Lenexa, KS, United States, 14 510(k) clearances

Name: Henry Schein Mso, LLC FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Henry Schein Mso, LLC is registered with the FDA (registration 3030235916) in Lenexa, KS, United States. It lists 3 device types. The FDA files 14 510(k) clearances under its listings, the newest dated January 13, 2020. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number: 3030235916
Address: 15600 W 99th St, Lenexa, KS, United States, 66219
Owner or operator: Henry Schein MSO, LLC (10089495)
Roles: Repackager or relabeler
First device listed: April 15, 2026
Registered through: 2026
Brand names listed: Anthogyr, Bien Air, Bien-Air, Dentsply Sirona, Hayes, KaVo, Lares Research, MK dent and more

Devices it lists

Device	Product code	Class	Role	Source
Handpiece, Air-Powered, Dental	EFB	1	Repackager or relabeler	accessdata.fda.gov
Handpiece, Contra- And Right-Angle Attachment, Dental	EGS	1	Repackager or relabeler	accessdata.fda.gov
Handpiece, Rotary Bone Cutting	KMW	2	Repackager or relabeler	accessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided	510(k) number	Device	Product code	Decision	Applicant	Source
January 13, 2020	K192409	Midwest Rhino XE and Air Motor M	EFB	Substantially Equivalent	Dentsply Sirona	accessdata.fda.gov
March 28, 2018	K173465	Concentrix MX-AC High-Speed Handpiece	EFB	Substantially Equivalent	Dentalez, Inc.	accessdata.fda.gov
February 23, 2017	K162926	Air-Powered Handpieces and Handpiece Attachments	EFB	Substantially Equivalent	W&H Dentalwerk Burmoos GmbH	accessdata.fda.gov
October 28, 2014	K141221	LARES ULTRALITE PROSTYLE HIGH-SPEED DENTAL HANDPIECES, LARES EURO PROSTYLE HIGH-SPEED DENTAL HANDPIECES, LARES TURBO+ PR	EFB	Substantially Equivalent	Lares Research, Inc.	accessdata.fda.gov
May 30, 2014	K131319	T1/T2/T3 TURBINE FAMILY	EFB	Substantially Equivalent	Sirona Dental Systems GmbH	accessdata.fda.gov
January 23, 2012	K113301	CONCENPIECE,HIGH-SPEED HANDPIECE SERIES	EFB	Substantially Equivalent	Dentalez, Inc.	accessdata.fda.gov
September 3, 2008	K073478	SUPERTORQUE HIGH-SPEED HANDPIECES AND GENTLEPOWER HANDPIECES AND ATTACHEMENTS	EFB	Substantially Equivalent	Sybron Dental Specialties, Inc.	accessdata.fda.gov
October 2, 2003	K032234	MK-DENT HIGH SPEED DENTAL HANDPIECE, MODELS HS 4021K, 4011K, 4012K, AND HS 6021K, 6011K, 6012K	EFB	Substantially Equivalent	Mk-Dent GmbH	accessdata.fda.gov
June 28, 2001	K011061	SURGICAL CONTRA-ANGEL HANDPIECES TYPES WS-56E,WS-75E/KM,WS-92 E/3,SURGICAL STRAIGHT HANDPIECES TYPES, S-9, S-10, S-11	EGS	Substantially Equivalent	W&H Dentalwerk Buermoos GmbH	accessdata.fda.gov
February 23, 1999	K984244	ORL-E-92 SURGICAL DRILL SYSTEM	EFB	Substantially Equivalent	Bien Air USA, Inc.	accessdata.fda.gov
December 10, 1998	K983183	GYRO LONG-LIFE,BLACK PEARL ECO, ONDINE &CROMA, PRESTIGE, BORA, AQUILON, MC2,MC3, BASCH, ISOLITE, OPTIMA, US, PLPE, CA, P	EFB	Substantially Equivalent	Bien Air USA, Inc.	accessdata.fda.gov
April 15, 1997	K970953	E-TYPE SPEED REDUCER CONTRA ANGLE	KMW	Substantially Equivalent	Nsk Nakanishi, Inc.	accessdata.fda.gov
September 24, 1996	K962542	AIR MOTOR HANDPIECE TN-102	EFB	Substantially Equivalent	Nsk Nakanishi, Inc.	accessdata.fda.gov
October 6, 1986	K863677	TRADITION HIGH SPEED HANDPIECE	EFB	Substantially Equivalent	Midwest	accessdata.fda.gov

Compare with other makers

Updated January 13, 2020. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.