Prosthetic devices · 21 CFR 872 Subpart D
Articulators
FDA device type “Articulators”.
- Companies listing it
- 8767 makers
- Brands and models
- 124
- 510(k) clearances
- 110 in five years
- FDA name
- Articulators
510(k) clearances per year, 1976–2026
Companies that list EJP
87 companies currently list this device type with FDA.
| 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 | 94 | 2026 |
| Premier Dental Products Company | United States | Maker | DENTAL ARTICULATORS · W.O.W. | 28 | 2026 |
| 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 · +3 | 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 | 8 | 2016 |
| Manufacturera Dental Continental | Mexico | Maker | MDC Dental Articulator | 2 | 2001 |
| 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 | — | — |
| 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 | — | — |
| Shanghai Alwings Medical Instrument Co.,Ltd. | China | Maker | Dental Articulator | — | — |
| Medcave Private Limited | Pakistan | Maker | Articulators | — | — |
| Panorama International | Pakistan | Maker | ARTICULATORS | — | — |
| Dentatus AB | Sweden | Maker | ARD · ARH · ARL · ARL/P · +1 | — | — |
| Garish Apparels | Pakistan | Maker | Tamzon Instruments Inc. | — | — |
| Surgicrafts | Pakistan | Maker | EJP / ARTICULATORS | — | — |
| 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 | — | — |
| 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 | — | — |
| SGS Export Intl. | Pakistan | Maker | Articulator | — | — |
| Spartech Instruments & Co. | Pakistan | Maker | ARTICULATORS | — | — |
| Melpex Beauty Instruments | Pakistan | Maker | ARTICULATORS | — | — |
| Armatech International | Pakistan | Maker | ARTICULATORS | — | — |
| 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 | — | — |
| Concise Enterprises | Pakistan | Maker | — | — | — |
| NR Surgical Company | Pakistan | Maker | ARTICULATORS | — | — |
| Bio-Art Equipamentos Odontologicos Ltda | Brazil | Maker | Articulator 4000-S · Articulator A7 Plus · Articulator Hanau Ulti-Mate | — | — |
| Chung Song Industrial Co. | South Korea | Maker | SUNBURST | — | — |
| Quality Concept (Pvt.) Ltd. | Pakistan | Maker | ARTICULATORS | — | — |
| Advanced Dental Designs | United States | Maker | Dental Articulator | — | — |
| Dongguan Yilong Medical Supplies Co., Ltd. | China | Maker | Articulator and Facebow | — | — |
| Worldlabusa | United States | Maker | Articlulator | — | — |
| 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 | — | — |
| Wholesale Dental MFG & Supply | United States | Maker | ARTICULATORS | — | — |
| Song Young Intl. Co. | Taiwan | Maker | ARTICULATOR | — | — |
| 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 |
| 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 | 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 | — | — |
| Jmu Dental, Inc. | United States | Repacker / relabeler | Articulator | — | — |
| 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 | — | — |
| Sklar Corporation | United States | Repacker / relabeler | Articulators | — | — |
| Meta Dental Corp. | United States | Repacker / relabeler | Articulator · S-Articulator | — | — |
| Guangzhou Four E's Scientific Co., Ltd. | China | Contract manufacturer | Dental Articulator | — | — |
| Aurum Group Ltd. | Canada | Contract manufacturer | AurumGroup | — | — |
| Head Dental Corp. | United States | Repacker / relabeler | PLIERS, ORTHODONTIC | — | — |
510(k) clearances
| Decided | 510(k) | Device | Applicant |
|---|---|---|---|
| 18 Jan 1994 | K926190 | ALRAND INC. (DENTAL HAND INSTRUMENTS) | Alrand, Inc. |
| 4 Dec 1989 | K896131 | GNATHOMAT ARTICULATOR | Ivoclar North America, Inc. |
| 12 Jun 1989 | K892373 | DENTAL PLASTIC BITE FORK | Texapol Corp. |
| 14 Nov 1988 | K884418 | PREMIER DIE-TRAK ARTICULATOR | Premier Dental Products Company |
| 11 Aug 1987 | K872943 | DISPOSABLE ARTICULATOR | Dentsply Intl., Inc. |
| 25 Sep 1986 | K863009 | GNATUS ARTICULATOR 4.300/4.300GP 8.600 & ORTOFLEX | Sds Dental, Inc. |
| 6 Mar 1986 | K854702 | PLASTIC MOUNTING RINGS | Almore Intl., Inc. |
| 4 Oct 1983 | K833039 | HANDY IIM | Shofu Inc |
| 13 May 1981 | K811075 | BALANCE ARTICULATOR | Almore Intl., Inc. |
| 5 May 1981 | K810971 | THE GNATOMET | Bauer, Cheng & Associates, Inc. |
| 8 Jul 1980 | K801342 | DISPOSABLE ARTICULATOR | Williams Gold Refining Co., Inc. |
Official records: FDA product classification for EJP · 21 CFR 872.3150.
Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026