Surgical devices · 21 CFR 872 Subpart E
Dental Retractor Accessories
FDA device type “Accessories, Retractor, Dental”.
- Companies listing it
- 160123 makers
- Brands and models
- 390
- 510(k) clearances
- 40 in five years
- FDA name
- Accessories, Retractor, Dental
510(k) clearances per year, 1976–2026
Companies that list EIF
160 companies currently list this device type with FDA.
| Company | Country | Role | Brands and models listed | Clearances | Latest |
|---|---|---|---|---|---|
| Institut Straumann AG | Switzerland | Maker | Neodent Retractor | 212 | 2026 |
| Dentis Co., Ltd. | South Korea | Maker | LED Mouth Prop | 37 | 2026 |
| Align Technology, Inc. | United States | Maker | Invisalign Lens | 16 | 2026 |
| Osstem Implant Co., Ltd. | South Korea | Maker | Mallet · Periosteal Elevator · TWMW | 68 | 2026 |
| Ivoclar Vivadent, AG | United States | Maker | OptraGate 2 · OptraGate Assortment · OptraGate Junior · OptraGate Junior Assortment Blue & Pink · +4 | 94 | 2026 |
| Pac-Dent Inc. | United States | Maker | — | 5 | 2022 |
| Coltene/Whaledent AG | Switzerland | Maker | AUTOCLAVABLE · KENDA Practicus · Polisher & bur caddy · POLISHER+BURR CADDY | 45 | 2022 |
| J. Morita USA, Inc. | United States | Maker | Free Access II Lip & Cheek Retractor | 42 | 2022 |
| DIO Corporation | South Korea | Maker | DIOnavi. Scan Retractor Lower jaw · DIOnavi. Scan Retractor Lower jaw Set · DIOnavi. Scan Retractor Upper jaw · DIOnavi. Scan Retractor Upper jaw Set | 14 | 2023 |
| Beijing Naton Technology Group Co. Ltd. | China | Maker | Inion Instrumentation | 10 | 2025 |
| Tp Orthodontics, Inc. | United States | Maker | Bonding accessories | 5 | 2022 |
| Leone S.P.A. | Italy | Maker | Lip retractor | 4 | 2025 |
| DCI International LLC | United States | Maker | Mouth Prop · Mouth Props, Adult · Mouth Props, Child · Mouth Props, Edentulous · +2 | 1 | 2025 |
| Shenzhen Rogin Medical Co., Ltd. | China | Maker | Fixing Plastic Wedges, Fixing Wooden Wedges, Silicone Wedges | 1 | 2025 |
| DentalMaster (Xiamen) Medical Technology Co., Ltd. | China | Maker | Mouth Retractor · Oral retractor · Positioning Ring · Stopper · +1 | 1 | 2026 |
| Denjoy Dental Co., Ltd. | China | Maker | RETRACTOR | 1 | 2025 |
| Hangzhou ChohoTech Co., Ltd | China | Maker | Intra oral camera (Ultra-S, Ultra-M, Ultra-L, Ultra-BP, Ultra-AP, Pro-S, Pro-M, Pro-L, Pro-BP, Pro-AP) · Retractor (iScan-AP); | 1 | 2026 |
| Dental Monitoring | France | Maker | DM ScanBox | 1 | 2024 |
| Reliance Orthodontic Products, Inc. | United States | Maker | ACCESS CHEEK RETRACTOR | 32 | 2021 |
| Philips Medical Systems International BV | Netherlands | Maker | Cheek Retractor · Zoom Retractors | 16 | 2010 |
| Sonendo, Inc. | United States | Maker | Ergo Arm | 9 | 2021 |
| Biomet Microfixation | United States | Maker | Mouth Prop · QC Removal Tool · Retractor | 8 | 2021 |
| Storz AM Mark GmbH | Germany | Maker | 1001110 / IRC | 2 | 2008 |
| GC Orthodontics | United States | Maker | — | 2 | 2015 |
| Gestenco International AB | Sweden | Maker | — | 1 | 2005 |
| TOR VM Ltd. | Russia | Maker | Cat.#1.100 Handle · Cat.#1.100T Handle, titanium · Cat.#1.101 Tweezers · Cat.#1.102 Tweezers · +136 | — | — |
| Shanghai Kangqiao Dental Instruments Factory | China | Maker | Color-coded instrument rings (Green/Blue/Purple/Pink/Red/Grey/Orange/Yellow) | — | — |
| Debo Medical Technology (Shijiazhuang) Co., Ltd. | China | Maker | Accessories, Retractor, Dental-Mouth Prop · Mouth Prop | — | — |
| Prodont-Holliger | France | Maker | MZP215IP- CONTRAST N4 PETIT MODELE I.P · MZP218IP - CONTRAST N1 84MMX85MM I.P · 233.20IP - CASSET DE CHIRU 285x92x3 I.P · 233.30 -CASSETTE STERILISATION EASY CL | — | — |
| Dental Studio | South Korea | Maker | Langenbeck Retractor · Midledorpt Retractor · Minnesota Retractor | — | — |
| Shenzhen Denco Medical Co Ltd | China | Maker | Fixing Plastic Wedges, Fixing Wooden Wedges, Silicone Wedges | — | — |
| Practicon, Inc. | United States | Maker | Lumindex 3 Barrier Sleeves | — | — |
| Huanghua Promisee Dental Co., Ltd | China | Maker | Dental retractor | — | — |
| Technimen Skillers | Pakistan | Maker | Retractors | — | — |
| Falcon Surgical Co. (Pvt.) Ltd. | Pakistan | Maker | Retractors | — | — |
| Commic Surgico | Pakistan | Maker | ACCESSORIES, RETRACTORS ALL TYPES, DENTAL · Cheek Retractors D/Ended | — | — |
| Shanghai Alwings Medical Instrument Co.,Ltd. | China | Maker | Amalgam Carrier · Cheek Retractor, Mouth Support · Mixing Gun · Mixing Tip · +2 | — | — |
| Medcave Private Limited | Pakistan | Maker | Dental Retractor | — | — |
| Accompany Surgical | Pakistan | Maker | — | — | — |
| Lacigrus International | Pakistan | Maker | ACCESSORIES, RETRACTOR, DENTAL | — | — |
| Pascal International | United States | Maker | Black Retrax System R-101 · Black Retrax System R-11 · Black Retrax System R-50 · Black Retrax System R-55 · +15 | — | — |
| Comfort Surgical Instruments | Pakistan | Maker | cheek retractor | — | — |
| Aesculap AG | Germany | Maker | Aesculap | — | — |
| Dentatus AB | Sweden | Maker | DENTATUS | — | — |
| Confident Instruments | Pakistan | Maker | Artman Instruments | — | — |
| Great Lakes Dental Technologies, Ltd. | United States | Maker | LIP RETRACTOR | — | — |
| Denta Craft Instruments | Pakistan | Maker | ACCESSORIES | — | — |
| ZOGEAR Medical Co., Ltd. | China | Maker | ACCESSORIES, RETRACTOR, DENTAL | — | — |
| Hilbro Instruments (Pvt) Ltd | Pakistan | Maker | ACCESSORIES, RETRACTOR, DENTAL · HILBRO INSTRUMENTS DENT | — | — |
| Solventum US LLC | United States | Maker | — | — | — |
| Garish Apparels | Pakistan | Maker | Tamzon Instruments Inc. | — | — |
| W.H. Holden Inc. DBA H & H Company | United States | Maker | RETRACTOR | — | — |
| Anqing Clean Dental Instrument Technology Co Ltd | China | Maker | Air Water Syringe Tips | — | — |
| Hubei Guarddent Medical Technology Co.,Ltd | China | Maker | Mouth Prop | — | — |
| BH Medical Products Co., Ltd | China | Maker | lip ring retractor · Mouth Prop | — | — |
| NuCare LLC | United States | Maker | NuCare · retractor self spanning | — | — |
| Cangzhou Lankang Medical Instruments Developing Co., Ltd. | China | Maker | Disposable Air-Water Syringe Tips, Curved Utility Syringes | — | — |
| Guangzhou Xinuo Technology Co., Ltd | China | Maker | Curved Utility Syringes,HP Mixing Tip;curved utility syringes · Disposable air-water Syringe Tips,Cover Of air-water Syringe tips | — | — |
| Shenzhen Senlede Technologies Co., Ltd | China | Maker | curved utility syringes · Disposable air-water Syringe Tips,Cover Of air-water Syringe tips; Curved Utility Syringes,HP Mixing Tip | — | — |
| Mident Ltd | United Kingdom | Maker | Disposable Trays · Retractor | — | — |
| READY SET IMPORT dba Mynt Professional | United States | Maker | bur holder | — | — |
| Crown Surgical Corp. | Pakistan | Maker | CROSURG | — | — |
| HuangHua DK Dental Co., LTD, | China | Maker | Dental Retractor, Mouth Props | — | — |
| Zhejiang Jasmine Oralcare Products Co., Ltd. | China | Maker | Scan-Mate (Black) · Scan-Mate (Blue) · Scan-Mate MagaGen · TisssuePro Distal Sleeve, MN Retractor · +3 | — | — |
| Henan Baistra Medical Devices Limited | China | Maker | ACCESSORIES, RETRACTOR, DENTAL | — | — |
| HILBRO International (Pvt) Ltd. | Pakistan | Maker | Dental Retractor · RETRACTOR | — | — |
| Medesy Srl | Italy | Maker | medesy | — | — |
| Ortho Solutions LC | United States | Maker | — | — | — |
| Zhejiang Yamei Medical Equipment Technology Co., Ltd. | China | Maker | Cheek Retractors, Mouth Opener | — | — |
| Boen Healthcare Co Ltd | China | Maker | Disposable Tray; Kindney Tray; Medical Tray | — | — |
| Xiantao S&J Protective Products Co., Ltd | China | Maker | Dental Retractor | — | — |
| Dentech Corp. | Japan | Maker | ACCESSORIES, RETRACTOR, DENTAL | — | — |
| SGS Export Intl. | Pakistan | Maker | Accessories, Retractor, Dental | — | — |
| Hager & Werken | Germany | Maker | Spandex, cheek retractor, Mirahold cheek retractor | — | — |
| Armor Dental Corporation | United States | Maker | Scan-Mate® (Black) · Scan-Mate® (Blue) · Scan-Mate® MegaGen · TissuePro Distal Sleeve, MN Retractor · +3 | — | — |
| Shandong Zhushi Pharmaceutical Group Co., Ltd | China | Maker | Mouth Prop | — | — |
| EMS Electro Medical Systems SA | Switzerland | Maker | GBT VISIGATE | — | — |
| Hexamed Pvt Ltd | Pakistan | Maker | Dental Retractor Accessories | — | — |
| Hospimed Mfg | Pakistan | Maker | Accessories, Retractors, Dental | — | — |
| Atria Co. | South Korea | Maker | Atria | — | — |
| Tontarra Medizintechnik GmbH | Germany | Maker | — | — | — |
| Zyris, Inc. | United States | Maker | ISODRY · ISOLITE · Isolite Anterior Isolation System · Isovac · +2 | — | — |
| Saga Dental Supply A | Norway | Maker | Lip and Cheek Retractor | — | — |
| Garnet Dentech | South Korea | Maker | Dental Retractor | — | — |
| Libral Traders Pvt Ltd | India | Maker | Headgear High Pull, Dental Cheek Retractors | — | — |
| Glorious Mercantile Corp. (Pvt.) Ltd. | Pakistan | Maker | DEVICE | — | — |
| Quality Concept (Pvt.) Ltd. | Pakistan | Maker | Various Types of Dental Retractors | — | — |
| Changzhou Shengkang Medical Instrument Co.,LTD | China | Maker | Air water syringe tip | — | — |
| Jay-Med | Pakistan | Maker | ACCESSORIES, RETRACTOR, DENTAL | — | — |
| Sure Dent Corporation | South Korea | Maker | RETRACTION CORD · Sure-Cord · Sure-Cord Clean | — | — |
| Unip Berhad | Malaysia | Maker | Cheek Retractor : Zoom Retractors | — | — |
| Dongguan Yilong Medical Supplies Co., Ltd. | China | Maker | Impression Gun | — | — |
| Sobytek Instruments Co. | Pakistan | Maker | ACESSORIES RETRACTORS | — | — |
| Ascentcare Dental Products | United States | Maker | Bite Buddy Mouth Prop System | — | — |
| J&J Instruments | United States | Maker | — | — | — |
| Perfect Group Corp. Ltd. | China | Maker | Oral Star;Perfect | — | — |
| Fomed Industries Inc. | China | Maker | Air / Water Syringe Tips | — | — |
| Quality Aspirators | United States | Maker | — | — | — |
| CranioMandibular Rehab, Inc. | United States | Maker | MBI · OraMPA · OraPlace | — | — |
| IPB Inc | United States | Maker | — | — | — |
| Kohler Medizintechnik GmbH | Germany | Maker | — | — | — |
| North Eos Industries Inc | Taiwan | Maker | DentSpec | — | — |
| Smile Line SA | Switzerland | Maker | Flexipalette & PhotoCad | — | — |
| STONE Instruments company | Pakistan | Maker | ACCESSORIES, RETRACTOR, DENTAL | — | — |
| Taizhou Rich Medical Products Co Ltd | China | Maker | Disposable Tray · Kindney Tray/medical tray | — | — |
| Bing Innovations LLC | United States | Maker | DentalVibe Flexi Tips · DentalVibe Gen 4 · DentalVibe Gen 5 | — | — |
| Dentozone Corporation | South Korea | Maker | Accessories for Suction Connector · 99 Suction Block | — | — |
| SFS Group Schweiz AG, Kunststoffwerk | Switzerland | Maker | Geistlich Panorama · OptraGate | — | — |
| GATE DENTAL SERVICES LTD ( T/A DentalOrganiser) | Ireland | Maker | BurButler | — | — |
| Orthopli Corp. | United States | Maker | Orthopli Corporation | — | — |
| ELDO S.r.l. | Italy | Maker | ACCESSORIES, RETRACTOR, DENTAL | — | — |
| Forefront (Xiamen) Medical Devices Co., Ltd. | China | Maker | — | — | — |
| Mectalent Ltd. | Finland | Maker | Inion Instrumentation | — | — |
| Ningbo Aolbea Oral Care Products Co., Ltd. | China | Maker | — | — | — |
| Phoenix Instruments, Inc. | United States | Maker | — | — | — |
| Sanbor Medical | United States | Maker | Paraband Dental | — | — |
| SFS Group Hungary Kft. | Hungary | Maker | OptraGate | — | — |
| SS Global | South Korea | Maker | Clean Cord | — | — |
| USTOMED INSTRUMENTE GmbH & Co. KG | Germany | Maker | — | — | — |
| Xinhua Surgical Instrument Co.,Ltd. | China | Maker | — | — | — |
| Nichrominox SA | France | Maker | — | — | — |
| Plastics Plus Technology, Inc. | United States | Maker | — | — | — |
| Sinntech Medical (Private) Limited | Pakistan | Maker | — | — | — |
| Spident Co., Ltd. | South Korea | Foreign exporter | Retraction Cord | 22 | 2026 |
| Young Innovations Inc | United States | Contract manufacturer | — | 23 | 2025 |
| Jedmed Instrument Co. | United States | Repacker / relabeler | RUBINSTEIN RETRACTOR | 4 | 1981 |
| Integra LifeSciences Corporation | United States | Contract manufacturer | Miltex | 2 | 2014 |
| G&H Wire Company | United States | Contract manufacturer | n/a | 2 | 2008 |
| Hager Worldwide, Inc. | United States | Manufacturer | Bite-Block · Lip-Ex · Mirahold · Spandex · +2 | 2 | 2005 |
| Aesculap, Inc. | United States | Lister | Aesculap · DENTAL RETRACTOR ACCESSORIES | 2 | 2006 |
| A. Titan Instruments, Inc. | United States | Contract manufacturer | Retractor | 1 | 2006 |
| One Dashcorp | United States | Repacker / relabeler | Valdent USA Green Mouth Props, Medium · Valdent USA Minnesota Cheek Retractor 5, 5 · Valdent USA Purple Mouth Props, Large · Valdent USA Yellow Mouth Props, Small | — | — |
| Wuxi Lyusmile Imp and Exp Co.,ltd | China | Private-label distributor | CHEEK RETRACTOR · rubber dam cheek retractor · RUBBER MOUTH SUPPORT · tongue protector | — | — |
| Dentimed Sao Joao LLC | United States | Repacker / relabeler | ANGELUS | — | — |
| TitanLinks Logistics LLC | United States | Repacker / relabeler | Mixing Pad | — | — |
| Jmu Dental, Inc. | United States | Repacker / relabeler | Dental Retractor | — | — |
| Aspen Surgical Products | United States | Contract manufacturer | Symmetry Surgical | — | — |
| Premium Plus Dental | United States | Lister | Premium Plus Mouth Retractors , Intraoral Lippers | — | — |
| Diadent Group Intl., Inc. | Canada | Foreign exporter | Cheek Retractors | — | — |
| GoldenDent | United States | Repacker / relabeler | Vibraject; Vibraject Clip Brackets, Vibraject Motor and Housing, Vibraject Control Knob | — | — |
| PDT Inc. | United States | Contract manufacturer | Minnesota Retractor Vestibulum Retractor · PDT | — | — |
| Yizur Ltd | Hong Kong SAR China | Foreign exporter | Mixing pad | — | — |
| TBS Dental | United States | Repacker / relabeler | TBS INOX USA | — | — |
| Wise Linkers LLC | United States | Repacker / relabeler | Artman Instruments | — | — |
| CARGUS International Inc. | United States | Repacker / relabeler | MARK3® Bur Blocks | — | — |
| Unisource Shanghai Ltd. | China | Foreign exporter | Scan-Mate (Black) · Scan-Mate (Blue) · Scan-Mate MegaGen · TissuePro Distal Sleeve, MN Retractor · +3 | — | — |
| battech | United States | Repacker / relabeler | Dappen dish · dental cheek retractor · Dental Plastic File Holder with Measuring · dental plastic/wooden wedge · +2 | — | — |
| Xplora USA LLC | United States | Manufacturer | Six Month Smiles | — | — |
| Shanghai Hua EN Industrial Co. Ltd. | China | Foreign exporter | bur holder | — | — |
| Ningbo Top Electric Appliance Co. Ltd. | China | Foreign exporter | Dental Tool Kit | — | — |
| Omnia SRL | United States | Contract manufacturer | maxil tray for instruments | — | — |
| SurgiPros LLC | United States | Repacker / relabeler | SURGIPROS | — | — |
| Evolve Dental Technologies, Inc. | United States | Repacker / relabeler | KoR Cheek Retractor | — | — |
| Alta Smiles, Inc | United States | Manufacturer | — | — | — |
| Common Sense Dental Products | United States | Repacker / relabeler | LogiBloc | — | — |
| Novo Surgical Inc. | United States | Repacker / relabeler | Novo Dental Retractor Accessories | — | — |
| MM Meder | Germany | Foreign exporter | Marlene Meder | — | — |
| Mainline Medical Dental Supply | Canada | Foreign exporter | — | — | — |
| Oketz Logistics LLC | United States | Repacker / relabeler | — | — | — |
| Xlent Global Inc | United States | Repacker / relabeler | — | — | — |
510(k) clearances
| Decided | 510(k) | Device | Applicant |
|---|---|---|---|
| 5 Oct 1994 | K940785 | MOUTH PROPS | Worldwide Dental, Inc. |
| 4 Dec 1987 | K873960 | LEWIS SAFE SLEEVE | Cheri Lewis, D.D.S. |
| 1 Mar 1983 | K830187 | FOCUS FLUID | Hematology Marketing Assoc. |
| 18 Feb 1983 | K830116 | SULCARINGS | North Pacific Dental, Inc. |
Official records: FDA product classification for EIF · 21 CFR 872.4565.
Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026