Registered with FDA
Henry Schein, Inc.
Melville, NY, United States. Lists 5 dental device types with FDA across 1 registered establishment, and holds 8 510(k) clearances as applicant.
- Device types listed
- 5
- Brands and models
- 5
- 510(k) clearances
- 81978–2004
- Markets registered in
- 114,134 registrations outside the US
- Establishments
- 1Germany
510(k) clearances per year, 1976–2026
Registered in 11 markets
Where regulators' registries name Henry Schein, Inc. as the manufacturer or the registration holder of a device.
| Market | Regulator | Named as | Name on the registry | Registrations | Issued | Records |
|---|---|---|---|---|---|---|
| United States | FDA | Lister | Henry Schein, Inc. | 8 clearances | 1978–2004 | Below |
| European Union | EUDAMED | Manufacturer | Henry Schein Inc. | 3,272 | — | Pure Global AI |
| Canada | Health Canada | Registration holder | HENRY SCHEIN INC. | 472 | 2003–2026 | Pure Global AI |
| United Kingdom | MHRA | Manufacturer | Henry Schein Inc | 150 | — | Pure Global AI |
| Saudi Arabia | SFDA | Manufacturer | Henry Schein, Inc. | 82 | — | Pure Global AI |
| Australia | TGA | Manufacturer | Henry Schein Inc | 66 | 2004–2024 | Pure Global AI |
| Singapore | HSA | Registration holder | HENRY SCHEIN PTE. LTD.Henry Schein, Inc · Henry Schein Pte Ltd | 37 | 2012–2024 | Pure Global AI |
| Serbia | ALIMS | Manufacturer | Henry Schein Inc. | 36 | 2025–2026 | Pure Global AI |
| Taiwan | TFDA | Manufacturer | HENRY SCHEIN INC.HENRY SCHEIN COMPANY. | 13 | 2006–2016 | Pure Global AI |
| Israel | AMAR | Manufacturer | Henry Schein Inc. | 3 | — | Pure Global AI |
| South Korea | MFDS | Manufacturer | Henry Schein Inc.Henry Schein Inc | 3 | 2000–2014 | Pure Global AI |
Outside the US the count is of all the company's device registrations in that market, dental or not · matched by company name and country · registry data read 12 Nov 2026
Devices listed with FDA
What Henry Schein, Inc. currently lists, by FDA device type, with the brand and model names on the listing.
| Device type | Category | Role | Brands and models | Listed since |
|---|---|---|---|---|
| Mouth MirrorEAX · Class 1 | Dental hand instruments | Lister | Mirror Disposable Dental | 2025 |
| Ultraviolet Activator for PolymerizationEBZ · Class 2 | Curing lights | Lister | Smartlite Pro Sleeves Refill | 2025 |
| ArticulatorsEJP · Class 1 | Articulators & facebows | Lister | Disposable Articulator Slotted | 2025 |
| Paper Saliva AbsorberKHR · Class 1 | — | Lister | Contour Neck Bibs | 2025 |
| Light Transmission Caries DetectorNTK · Class 2 | Caries detection devices | Lister | Smartlite Pro Sleeves Refill | 2025 |
Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026
510(k) clearances
Clearances on which FDA names Henry Schein, Inc. as the applicant, including filings under its other names.
| Decided | 510(k) | Device | Device type |
|---|---|---|---|
| 29 Jun 2004 | K041580 | IMAGERAYI | MUH Digital Extraoral Source X-Ray System |
| 7 Nov 1986 | K862384 | SCHEIN AP-1 AIR POLISHING UNIT | KOJ Airbrush |
| 30 Oct 1986 | K862385 | SCHEIN BLEACHING UNIT | EEG Heat Source for Bleaching Teeth |
| 25 Apr 1984 | K841199 | FIBERGLASS MOUTH MIRRORS | EAX Mouth Mirror |
| 21 Feb 1984 | K834055 | VANADIUM EXCAVATORS SIZES 0-6 | EKC Operative Dental Excavator |
| 3 Feb 1984 | K834056 | SCHEIN COTTON ROLLS, NON-STERILE | EFN Roll Cotton |
| 20 May 1980 | K801079 | KWIX-BITE X-RAY FILM HOLDER | EGZ X-Ray Film Holder |
| 4 Dec 1978 | K781592 | SURGICAL ASPIRATOR TIPS | DYN Saliva Ejector Mouthpiece |
Also lists devices cleared under other names
Henry Schein, Inc. 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. (1).
| Decided | 510(k) | Device | Applicant | Device type |
|---|---|---|---|---|
| 20 Nov 2019 | K191865 | SmartLite Pro Modular LED Curing Light | Dentsply Sirona, Inc. | EBZ Ultraviolet Activator for Polymerization |
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| HENRY SCHEIN SERVICES GMBHFDA reg. 3009142030 | Gallin Mecklenburg-Western Pomerania, Germany | Foreign exporter |
Other names on FDA records
Henry Schein Services GmbH
Sources
FDA establishment registration & device listing (search FDA, owner/operator 2411236). 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.