Registered with FDA
Henry Schein MSO, LLC
Lenexa, KS, United States. Lists 3 dental device types with FDA across 1 registered establishment.
- Device types listed
- 3
- Brands and models
- 16
- 510(k) clearances
- 0as applicant
- Markets registered in
- 1United States
- Establishments
- 1United States
Devices listed with FDA
What Henry Schein MSO, LLC currently lists, by FDA device type, with the brand and model names on the listing.
| Device type | Category | Role | Brands and models | Listed since |
|---|---|---|---|---|
| Dental Air-Powered HandpieceEFB · Class 1 | Dental handpieces | Lister | AnthogyrBien AirBien-AirDentsply SironaHayesKaVoLares ResearchMidwestMK dentMorita 4 moreNSKSironaStarDentalW&H | 2026 |
| Dental Contra- and Right-Angle Attachment HandpieceEGS · Class 1 | Dental handpieces | Lister | W&H | 2026 |
| Rotary Bone Cutting HandpieceKMW · Class 2 | Surgical drills & motors | Lister | NSK | 2026 |
Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026
Also lists devices cleared under other names
Henry Schein MSO, LLC lists these devices with FDA today. The clearance names a different applicant, as happens after a rename, an acquisition or a private-label agreement.
Original applicants: Dentsply Sirona, Inc. (2), Dentalez, Inc. (2), Bien Air USA, Inc. (2), Nsk Nakanishi, Inc. (2), W&H Dentalwerk Bürmoos GmbH (1), Lares Research (1), Sybron Dental Specialties (1), MK-dent GmbH (1).
| Decided | 510(k) | Device | Applicant | Device type |
|---|---|---|---|---|
| 13 Jan 2020 | K192409 | Midwest Rhino XE and Air Motor M | Dentsply Sirona, Inc. | EFB Dental Air-Powered Handpiece |
| 28 Mar 2018 | K173465 | Concentrix MX-AC High-Speed Handpiece | Dentalez, Inc. | EFB Dental Air-Powered Handpiece |
| 23 Feb 2017 | K162926 | Air-Powered Handpieces and Handpiece Attachments | W&H Dentalwerk Bürmoos GmbH | EFB Dental Air-Powered Handpiece |
| 28 Oct 2014 | K141221 | LARES ULTRALITE PROSTYLE HIGH-SPEED DENTAL HANDPIECES, LARES EURO PROSTYLE HIGH-SPEED DENTAL HANDPIECES, LARES TURBO+ PR | Lares Research | EFB Dental Air-Powered Handpiece |
| 30 May 2014 | K131319 | T1/T2/T3 TURBINE FAMILY | Dentsply Sirona, Inc. | EFB Dental Air-Powered Handpiece |
| 23 Jan 2012 | K113301 | CONCENPIECE,HIGH-SPEED HANDPIECE SERIES | Dentalez, Inc. | EFB Dental Air-Powered Handpiece |
| 3 Sep 2008 | K073478 | SUPERTORQUE HIGH-SPEED HANDPIECES AND GENTLEPOWER HANDPIECES AND ATTACHEMENTS | Sybron Dental Specialties | EFB Dental Air-Powered Handpiece |
| 2 Oct 2003 | K032234 | MK-DENT HIGH SPEED DENTAL HANDPIECE, MODELS HS 4021K, 4011K, 4012K, AND HS 6021K, 6011K, 6012K | MK-dent GmbH | EFB Dental Air-Powered Handpiece |
| 28 Jun 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 | W&H Dentalwerk Buermoos GmbH | EGS Dental Contra- and Right-Angle Attachment Handpiece |
| 23 Feb 1999 | K984244 | ORL-E-92 SURGICAL DRILL SYSTEM | Bien Air USA, Inc. | EFB Dental Air-Powered Handpiece |
| 10 Dec 1998 | K983183 | GYRO LONG-LIFE,BLACK PEARL ECO, ONDINE &CROMA, PRESTIGE, BORA, AQUILON, MC2,MC3, BASCH, ISOLITE, OPTIMA, US, PLPE, CA, P | Bien Air USA, Inc. | EFB Dental Air-Powered Handpiece |
| 15 Apr 1997 | K970953 | E-TYPE SPEED REDUCER CONTRA ANGLE | Nsk Nakanishi, Inc. | KMW Rotary Bone Cutting Handpiece |
| 24 Sep 1996 | K962542 | AIR MOTOR HANDPIECE TN-102 | Nsk Nakanishi, Inc. | EFB Dental Air-Powered Handpiece |
| 6 Oct 1986 | K863677 | TRADITION HIGH SPEED HANDPIECE | Midwest | EFB Dental Air-Powered Handpiece |
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| HENRY SCHEIN MSO, LLCFDA reg. 3030235916 | Lenexa, KS, United States | Repacker / relabeler |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10089495). FDA 510(k) premarket notification file. FDA data as of 2 Nov 2026; snapshot 12 Nov 2026. The location shown is the address on FDA's record.