Articulators & facebows: manufacturers and brands
88 companies make or specify articulators among the 114 that list one with FDA, under 196 brand and model names. FDA has issued 12 510(k) clearances in this category, 0 of them in the last five years.
510(k) clearances per year, 1976–2026
Articulator manufacturers
Makers first, then the most recently active. “Maker” means the company manufactures the device or owns its specifications; a “lister” repacks, relabels, imports or distributes it.
| Company | Country | Role | Brands and models listed | Clearances | Latest |
|---|---|---|---|---|---|
| Dentsply Sirona, Inc. | United States | Maker | — | 148 | 2026 |
| Prismatik Dentalcraft, Inc. | United States | Maker | ScanArt | 56 | 2026 |
| Align Technology, Inc. | United States | Maker | Cadent Articulator · Cadent Articulator Kit · iTero Articulator Kit | 16 | 2026 |
| Shofu Inc | Japan | Maker | HANDY IIM · PRO ARCH | 96 | 2025 |
| Ivoclar Vivadent, AG | United States | Maker | Articulator CA 3 · STRATOS · Bite Fork · Bite Fork Set · +5 | 94 | 2026 |
| Premier Dental Products Company | United States | Maker | DENTAL ARTICULATORS · W.O.W. | 28 | 2026 |
| Neobiotech Co., Ltd. | South Korea | Maker | SAM Gothic Arch · SmileArch M KIT | 17 | 2024 |
| Zirkonzahn Srl | Italy | Maker | — | 10 | 2023 |
| Keystone Industries | United States | Maker | Deluxe Magnetic Articulator · Keystone Articulators · Luxury Articulator | 2 | 2025 |
| Amann Girrbach AG | Austria | Maker | Artex BN · Artex CN · Artex CP · Artex CPR · +14 | 3 | 2026 |
| KaVo Dental GmbH | Germany | Maker | 0.622.5000 - ARCUS · 105900 - ARCUSevo | 2 | 2021 |
| Shenzhen Rogin Medical Co., Ltd. | China | Maker | articulators/flask | 1 | 2025 |
| Buffalo Dental Mfg. Co., Inc. | United States | Maker | Buffalo Articulator | 11 | 1996 |
| Whip Mix Corporation | United States | Maker | Denar · Hanau · Whip Mix Articulator · Cross Ref · +2 | 8 | 2016 |
| Forestadent Bernhard Forster GmbH | Germany | Maker | Facebow | 4 | 2011 |
| Tomy, Inc. | Japan | Maker | — | 4 | 2018 |
| Manufacturera Dental Continental | Mexico | Maker | MDC Dental Articulator | 2 | 2001 |
| GC Orthodontics | United States | Maker | — | 2 | 2015 |
| Dental Morelli | Brazil | Maker | — | 2 | 2014 |
| Seilglobal CO., Ltd | South Korea | Maker | ADD POP BOW | 1 | 2015 |
| Osung Mnd Co Ltd | South Korea | Maker | ACBA1 | — | — |
| Metro Medical | Pakistan | Maker | Articulators · Articulators, Adjustable Articulator · Articulators, Anatomical Articulator · Articulators, Average Articulator with Mignets · +13 | — | — |
| Dentaurum GmbH & Co. KG | Germany | Maker | Face bow · Face bows · Face mask · Noninium face bow · +1 | — | — |
| B. Ali Impex | Pakistan | Maker | BALI · DOCTOR NICE | — | — |
| Shenzhen Denco Medical Co Ltd | China | Maker | articulators/flask | — | — |
| Technimen Skillers | Pakistan | Maker | ARTICULATORS DENTAL | — | — |
| Falcon Surgical Co. (Pvt.) Ltd. | Pakistan | Maker | Articulators · Facebow | — | — |
| Shanghai Alwings Medical Instrument Co.,Ltd. | China | Maker | Dental Articulator | — | — |
| Medcave Private Limited | Pakistan | Maker | Articulators | — | — |
| Panorama International | Pakistan | Maker | ARTICULATORS | — | — |
| Lacigrus International | Pakistan | Maker | FACEBOW | — | — |
| Dentatus AB | Sweden | Maker | ARD · ARH · ARL · ARL/P · +7 | — | — |
| Garish Apparels | Pakistan | Maker | Tamzon Instruments Inc. | — | — |
| Surgicrafts | Pakistan | Maker | EJP / ARTICULATORS | — | — |
| Orthodontic Manufacturer SIA SRL | Italy | Maker | FACEBOW · SIA ORTHODONTIC MANUFACTURER | — | — |
| Acheron Instruments (Pvt.) Ltd. | Pakistan | Maker | Articulators | — | — |
| Surgiscape | Pakistan | Maker | ARTICULATORS | — | — |
| Garana Industries (PVT) Ltd | Pakistan | Maker | DENTAL ARTICULATOR | — | — |
| Choose Surgical Instruments | Pakistan | Maker | ARTICULATORS | — | — |
| Nadir & Co. | Pakistan | Maker | Articulators | — | — |
| Astar Orthodontics Inc | China | Maker | facebow w/loops · facebow, universal | — | — |
| Daddy D Pro | Pakistan | Maker | Articulators | — | — |
| Mount Blonck Trading | Pakistan | Maker | Lab Dental Articulator | — | — |
| Surjex | Pakistan | Maker | ARTICULATORS | — | — |
| Medesy Srl | Italy | Maker | medesy | — | — |
| Meed Skills Surgical | Pakistan | Maker | Meed Skills Surgical | — | — |
| Hangzhou Wise Medical Device Co.,Ltd | China | Maker | Facebow | — | — |
| Volgo Care International (Private) Limited | Pakistan | Maker | VOLGOCARE | — | — |
| SGS Export Intl. | Pakistan | Maker | Articulator | — | — |
| Spartech Instruments & Co. | Pakistan | Maker | ARTICULATORS | — | — |
| Melpex Beauty Instruments | Pakistan | Maker | ARTICULATORS | — | — |
| Armatech International | Pakistan | Maker | ARTICULATORS | — | — |
| Central Surgical Co. Pvt. Ltd. | Pakistan | Maker | Dental Facebows, Traction Bows | — | — |
| Sabokay Industries | Pakistan | Maker | Articulators | — | — |
| Darleys Surgical Co. | Pakistan | Maker | ARTICULATORS | — | — |
| Hazel Enterprises | Pakistan | Maker | ARTICULATORS | — | — |
| Surgikare | Pakistan | Maker | ARTICULATORS | — | — |
| T.A. Walthem & Company | Pakistan | Maker | ARTICULATORS | — | — |
| Washington Surgical International | Pakistan | Maker | ARTICULATORS | — | — |
| Infirmary Medical Supplies | Pakistan | Maker | ARTICULATORS | — | — |
| Madina Surgical Works | Pakistan | Maker | ARTICULATORS | — | — |
| Guangzhou Cheer-U Material Technology Co., Ltd | China | Maker | Facebow, Facebow | — | — |
| Concise Enterprises | Pakistan | Maker | — | — | — |
| NR Surgical Company | Pakistan | Maker | ARTICULATORS | — | — |
| PNUAdd Co., Ltd. | South Korea | Maker | ADD POP BOW | — | — |
| SITEC (Pvt.) Ltd. | Pakistan | Maker | Facebow | — | — |
| ASA Dental | Italy | Maker | Facebow | — | — |
| Avilign Medical | Pakistan | Maker | Facebow | — | — |
| Bio-Art Equipamentos Odontologicos Ltda | Brazil | Maker | Articulator 4000-S · Articulator A7 Plus · Articulator Hanau Ulti-Mate · Elite Facebow · +1 | — | — |
| Chung Song Industrial Co. | South Korea | Maker | SUNBURST | — | — |
| Hangzhou PengWu Medical Equipment Co.,Ltd | China | Maker | SmileStreamSolutions / PW Ortho | — | — |
| Quality Concept (Pvt.) Ltd. | Pakistan | Maker | ARTICULATORS | — | — |
| Tecnident Equipamentos Ortodonticos Ltda. | Brazil | Maker | TECNIDENT EQUIPAMENTOS ORTODONTICOS | — | — |
| Advanced Dental Designs | United States | Maker | Dental Articulator · AD2 Anatomic Facebow · Hinge Axis Recorder · Magnetic Mounting System · +1 | — | — |
| Dongguan Yilong Medical Supplies Co., Ltd. | China | Maker | Articulator and Facebow | — | — |
| Worldlabusa | United States | Maker | Articlulator · Facebow | — | — |
| Zentro Enterprise Pvt. Ltd. | India | Maker | ARTICULATORS | — | — |
| Shioda Dental Co. | Japan | Maker | SHIODA | — | — |
| Topway Dental Laboratory Co., Ltd | China | Maker | Articulators | — | — |
| Myotronics-Noromed, Inc | United States | Maker | TERMINUS ARTICULATOR | — | — |
| SAM Präzisionstechnik GmbH | Germany | Maker | axiosnapmount · axioprisa · SAM | — | — |
| Wholesale Dental MFG & Supply | United States | Maker | ARTICULATORS | — | — |
| Song Young Intl. Co. | Taiwan | Maker | ARTICULATOR | — | — |
| Zhejiang Risheng Medical Technology Co Ltd | China | Maker | Face Bow | — | — |
| Greation Manufacturing Inc | Taiwan | Maker | Articulators | — | — |
| Panadent Corporation | United States | Maker | Panadent Articulators | — | — |
| SCHOEPF Fertigungstechnik GmbH | Austria | Maker | Articulator CA 3 | — | — |
| Gamma Medizinisch Wissenschaftliche Fortbildungsge | Austria | Maker | — | — | — |
| Sybron Dental Specialties | United States | Contract manufacturer | — | 203 | 2026 |
| American Orthodontics | United States | Contract manufacturer | 300 Series Facebows | 44 | 2026 |
| Parkell, Inc | United States | Contract manufacturer | — | 58 | 2025 |
| Imicryl Dis Malzemeleri Sanayi VE Ticaret AS | Türkiye | Manufacturer | ARTICULATORS | 5 | 2022 |
| Jensen Industries, Inc. | United States | Manufacturer | Artex | 17 | 2019 |
| Biomet Microfixation | United States | Manufacturer | Articulator | 8 | 2021 |
| Henry Schein, Inc. | United States | Foreign exporter | Disposable Articulator Slotted | 8 | 2004 |
| Dentatus USA Ltd. | United States | Repacker / relabeler | Articulators · Facebow | 4 | 2004 |
| Major Prodotti Dentari S.P.A. | Italy | Manufacturer | AVM 100 | 3 | 2008 |
| Wuxi Lyusmile Imp and Exp Co.,ltd | China | Private-label distributor | BRASS ARTICULATOR · Disposable Articulator · PLASTIC ARTICULATOR · Zin Articulator | — | — |
| Dentimed Sao Joao LLC | United States | Repacker / relabeler | Angelus · STAR5 | — | — |
| Jmu Dental, Inc. | United States | Repacker / relabeler | Articulator · Facebow | — | — |
| Patterson Companies, Inc. | United States | Foreign exporter | Patterson® Articulator | — | — |
| Aspen Surgical Products | United States | Contract manufacturer | Symmetry Surgical | — | — |
| Premium Plus Dental | United States | Lister | Premium Plus Dental Articulator | — | — |
| TBS Dental | United States | Repacker / relabeler | TBS INOX USA | — | — |
| IDOC Dental Lab | United States | Contract manufacturer | ADD POP BOW | — | — |
| Sklar Corporation | United States | Repacker / relabeler | Articulators | — | — |
| First Dental Supplies LLC | United States | Repacker / relabeler | FACEBOW | — | — |
| Ortho Solutions LC | United States | Contract manufacturer | DynaFlex FACE BOW | — | — |
| Meta Dental Corp. | United States | Repacker / relabeler | Articulator · S-Articulator | — | — |
| Guangzhou Four E's Scientific Co., Ltd. | China | Contract manufacturer | Dental Articulator | — | — |
| Phoenix Orthodontics Inc | United States | Repacker / relabeler | Phoenix Bite Plate Facebows · Phoenix Series 100 Facebows | — | — |
| Aurum Group Ltd. | Canada | Contract manufacturer | AurumGroup | — | — |
| Head Dental Corp. | United States | Repacker / relabeler | PLIERS, ORTHODONTIC | — | — |
| Novo Surgical Inc. | United States | Repacker / relabeler | — | — | — |
Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026
Where articulators are made
Number of makers in this category with a manufacturing establishment in the country.
FDA device types in this category
| Device type | Class | Regulation | Makers | Clearances |
|---|---|---|---|---|
| ArticulatorsEJP | 1 | 872.3150 | 67 | 11 |
| FacebowKCR | 1 | 872.3220 | 32 | 1 |
Recent clearances
| Decided | 510(k) | Device | Applicant | Device type |
|---|---|---|---|---|
| 18 Jan 1994 | K926190 | ALRAND INC. (DENTAL HAND INSTRUMENTS) | Alrand, Inc. | EJP Articulators |
| 4 Dec 1989 | K896131 | GNATHOMAT ARTICULATOR | Ivoclar North America, Inc. | EJP Articulators |
| 12 Jun 1989 | K892373 | DENTAL PLASTIC BITE FORK | Texapol Corp. | EJP Articulators |
| 14 Nov 1988 | K884418 | PREMIER DIE-TRAK ARTICULATOR | Premier Dental Products Company | EJP Articulators |
| 11 Aug 1987 | K872943 | DISPOSABLE ARTICULATOR | Dentsply Intl., Inc. | EJP Articulators |
| 25 Sep 1986 | K863009 | GNATUS ARTICULATOR 4.300/4.300GP 8.600 & ORTOFLEX | Sds Dental, Inc. | EJP Articulators |
| 6 Mar 1986 | K854702 | PLASTIC MOUNTING RINGS | Almore Intl., Inc. | EJP Articulators |
| 4 Oct 1983 | K833039 | HANDY IIM | Shofu Inc | EJP Articulators |
| 28 Apr 1983 | K830775 | FACEBOW FOR BALANCE ARTICULATOR | Almore Intl., Inc. | KCR Facebow |
| 13 May 1981 | K811075 | BALANCE ARTICULATOR | Almore Intl., Inc. | EJP Articulators |
| 5 May 1981 | K810971 | THE GNATOMET | Bauer, Cheng & Associates, Inc. | EJP Articulators |
| 8 Jul 1980 | K801342 | DISPOSABLE ARTICULATOR | Williams Gold Refining Co., Inc. | EJP Articulators |