Surgical devices · 21 CFR 872 Subpart E
All Types Retractor
FDA device type “Retractor, All Types”.
- Companies listing it
- 312239 makers
- Brands and models
- 634
- 510(k) clearances
- 80 in five years
- FDA name
- Retractor, All Types
510(k) clearances per year, 1976–2026
Companies that list EIG
312 companies currently list this device type with FDA.
| Company | Country | Role | Brands and models listed | Clearances | Latest |
|---|---|---|---|---|---|
| Align Technology, Inc. | United States | Maker | Invisalign Cheek Retractor, Medium | 16 | 2026 |
| Zest Anchors, LLC | United States | Maker | — | 26 | 2026 |
| Sybron Dental Specialties | United States | Maker | OptiView · OptiView Premier | 203 | 2026 |
| Ultradent Products, Inc. | United States | Maker | IsoBlock · OpalDam · OpalDam Green · OT Gingival Barrier · +3 | 95 | 2026 |
| KLS Martin SE & Co. KG | Germany | Maker | — | 43 | 2026 |
| S.i.n. - Sistema de Implante Nacional S.A. | Brazil | Maker | Cheek Retractor | 4 | 2025 |
| Premier Dental Products Company | United States | Maker | PREMIER RETRACTORS | 28 | 2026 |
| Dentscare Ltda | Brazil | Maker | Arcflex | 10 | 2024 |
| Pac-Dent Inc. | United States | Maker | Pac-Dent Disposable Mouth Prop | 5 | 2022 |
| The Belport Company, Inc. DBA Gingi-Pak | United States | Maker | — | 2 | 2026 |
| Premium Plus (Dongguan) Limited | China | Maker | Cheek retractor, mouth props, intraoral lippers | 2 | 2025 |
| Ortho Organizers, Inc. | United States | Maker | Double Ended Lip Retractor · Extraoral Cheek Retractors · High Heat Cheek Retractor · Intraoral Cheek Retractors · +4 | 8 | 2025 |
| Tp Orthodontics, Inc. | United States | Maker | Lip and Cheek Retractor | 5 | 2022 |
| 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 Cheek Retractor · ScanBox pro | 1 | 2024 |
| Hu-Friedy Mfg Co., LLC | United States | Maker | Hu-Friedy Mfg Co.,LLC | 8 | 2012 |
| Biomet Microfixation | United States | Maker | Cheek Retractor · Condyle Retractor · Retractor · TMJ Retractor | 8 | 2021 |
| Premium Plus International Limited | Hong Kong SAR China | Maker | 2030 Intraoral Lippers · 2040 Intraoral Lippers · 2050A-2 Cheek Retractors · 2050C-2 Cheek Retractors · +5 | 3 | 2017 |
| Integra LifeSciences Corporation | United States | Maker | Integra · Jarit · MicroFrance · Miltex · +1 | 2 | 2014 |
| Storz AM Mark GmbH | Germany | Maker | Hook · Retractor | 2 | 2008 |
| Dental Morelli | Brazil | Maker | — | 2 | 2014 |
| Mci Medical Concept Innovation, Inc. | United States | Maker | A021.1413 RETRACTOR CHEEK OF TRANSBUCCAL | 1 | 2019 |
| B&L Biotech Co., Ltd. | South Korea | Maker | JETrac | 1 | 2006 |
| Zhengzhou Huaer Electro-optics Technology Co., Ltd. | China | Maker | Cheek Retractor | 1 | 2020 |
| Arnold Tuber Industries | United States | Maker | Retractor | 1 | 2009 |
| Sawbros Industries Pvt., Ltd. | India | Maker | Lip-Retractor | 1 | 2017 |
| Bioseal | United States | Maker | Bioseal Cheek Retractor | 1 | 1988 |
| Osung Mnd Co Ltd | South Korea | Maker | GRM1 · GRM2 · GRM3 · RTAN20 · +24 | — | — |
| ErgoDenta ApS | Denmark | Maker | Bowdler Henry Retractor, 16cm · Cawood-Minnesota, 2x16cm, 15.5cm · Farabeuf Retractor, Set of 2 pcs, 12cm Fig. 1, 26 x 10 mm / 30 x 13 mm Fig. 2, 30 x 10 mm / 34 x 13 mm · Langenbeck Retractor, 29 x 10 mm, 22cm · +17 | — | — |
| Zain's Medical Image | Pakistan | Maker | Army Retractor · Army/Navy Retractor · Balfour Retractor 10" · Balfour Retractor 7" · +37 | — | — |
| Densol International (Private) Limited | Pakistan | Maker | Austin Tissue Retractor · Caewood Minnesota Retractor Large · Caewood Minnesota Retractor Small · Cheek Retractor Double Ended · +22 | — | — |
| Metro Medical | Pakistan | Maker | Chaannel Retractor, Obwegeser, 16 cm · Check Retractor · Chin Retractor, Obwegeser, 15.5 cm · Delicate Retractors, Barsky, 15 cm · +31 | — | — |
| Schobell Industrial Ltda | Brazil | Maker | Bishop Retractor · Branemark retractor · Cavity retractor · Condylar positioner · +11 | — | — |
| Signor Seven International | Pakistan | Maker | Adult Cheek Retractors (C-Shape) SKU 19-139 · Adult Intraoral Lip & Cheek Retractor, SKU 19-141 · Bishop Cheek Retractor SKU 13-1416-P · Child Cheek Retractors (C-Shape) SKU 19-140 · +17 | — | — |
| Shanghai Kangqiao Dental Instruments Factory | China | Maker | Cheek retractor · Periotomes GRM 1/GRM 2 · Retractors curved · Retractors straight | — | — |
| Dentaurum GmbH & Co. KG | Germany | Maker | Lip rectractor | — | — |
| 株式会社ＹＤＭ | Japan | Maker | Cheek Retractor A (2 ea.) · Cheek Retractor Anglewider (2 ea.) · Cheek Retractor Anglewider for Child (2 ea.) · Cheek Retractor Anglewider One Hand (2 ea.) · +18 | — | — |
| Debo Medical Technology (Shijiazhuang) Co., Ltd. | China | Maker | Retractor, All Types -Cheek Retractor | — | — |
| Bashir Jamil & Bros. (Pvt.), Ltd. | Pakistan | Maker | UNIVERSITY OF MINNESOTA RETRACTOR | — | — |
| TDV Dental Ltda | Brazil | Maker | MAXVIEW | — | — |
| Aspen Surgical Products | United States | Maker | Symmetry Surgical | — | — |
| Huanghua Promisee Dental Co., Ltd | China | Maker | mouth prop · RETRACTOR · rubber dam retractor | — | — |
| Technimen Skillers | Pakistan | Maker | Blafour Retractor, ophthalmic retractor, weitlaner, retractor, cheek retractor, · Cross Action Retractor · General Retractor · Rigby Retractor · +2 | — | — |
| Cislak Manufacturing, Inc. | United States | Maker | Cislak · Zoll Dental | — | — |
| Falcon Surgical Co. (Pvt.) Ltd. | Pakistan | Maker | Retractor | — | — |
| Pomee Corporation | Pakistan | Maker | U/Minnesota Cheek Retractor | — | — |
| Commic Surgico | Pakistan | Maker | Cheek Retractors · Lip Retractors · Molt Mouth Retractors · Mouth Gags · +1 | — | — |
| Endo Tech Instruments | Pakistan | Maker | Retractors, Lip & Cheek Retractors, Hooks, Depressors & Mouth Gags, Sterilizing Forcep | — | — |
| Medcave Private Limited | Pakistan | Maker | Retractor | — | — |
| Nordent MFG., Inc. | United States | Maker | NORDENT PERIOSTEALS | — | — |
| Panorama International | Pakistan | Maker | RETRACTOR, ALL TYPES | — | — |
| Shanghai Dochem Industries Co., Ltd. | China | Maker | Cheek retractor | — | — |
| Denovo Dental Inc | United States | Maker | D071514 · D071515 · D071516 · D071517 · +4 | — | — |
| Accompany Surgical | Pakistan | Maker | RETRACTOR | — | — |
| Lacigrus International | Pakistan | Maker | RETRACTOR, ALL TYPES | — | — |
| Comfort Surgical Instruments | Pakistan | Maker | RETRACTOR ALL TYPES | — | — |
| Aesculap AG | Germany | Maker | Aesculap | — | — |
| Adolf Schweick Hardt GmbH & Co | Germany | Maker | RETRACTOR, ALL TYPES | — | — |
| Hangzhou Westlake Biomaterial Co., Ltd. | China | Maker | Retractor, Orthodontic · Retractor, Orthodontic (All types of orthodontic Retractors) · XIHUBIOM | — | — |
| Confident Instruments | Pakistan | Maker | Artman Instruments | — | — |
| Tangshan Zhengtong Exhibition Co., Ltd. | China | Maker | Cheek Retractor | — | — |
| Denta Craft Instruments | Pakistan | Maker | RETRACTOR | — | — |
| Jiangxi IVISMILE Technology Co.,Ltd | China | Maker | Cheek Retractor; Mouth Opener; Lip Retractor | — | — |
| Medisporex Private Limited | Pakistan | Maker | MEDIS | — | — |
| Otto Leibinger GmbH | Germany | Maker | Minnesota Retractor · Retractors all types | — | — |
| Garish Apparels | Pakistan | Maker | Tamzon Instruments Inc. | — | — |
| Acme Enterprises | Pakistan | Maker | TBS DENTAL | — | — |
| Hermann GmbH | Germany | Maker | RETRACTOR | — | — |
| Surgicrafts | Pakistan | Maker | EIG / RETRACTOR, ALL TYPES | — | — |
| W.H. Holden Inc. DBA H & H Company | United States | Maker | RETRACTORS, MOUTH PROPS | — | — |
| G.A. Surgical (Pvt.) Ltd. | Pakistan | Maker | ALM RETRACTOR, CROSS ACTION RETRACTOR, · Balfour Retractor · CHEEK RETRACTOR, COLUMBIA LIP RETRACTOR, · FARABEUF RETRACTOR, LIP RETRACTOR, · +7 | — | — |
| Acheron Instruments (Pvt.) Ltd. | Pakistan | Maker | Retractors | — | — |
| Hubei Guarddent Medical Technology Co.,Ltd | China | Maker | Cheek Retractor | — | — |
| Silver Plus Corp. | Pakistan | Maker | RETRACTOR, ALL TYPES | — | — |
| Huizhou Videya Technology Co., Ltd. | China | Maker | VDEYA, Rubber dam cheek retractor, Regular, Small, Junior | — | — |
| NuCare LLC | United States | Maker | NuCare Dental Retractor · retractor self spanning adult 50mm plastic blue · retractor self spanning adult plastic w/holder · retractor self spanning child plastic w/holder | — | — |
| Shanghai Medical Instruments (Group) Ltd. Corp. | China | Maker | DENTAL RETRACTOR | — | — |
| Surgiscape | Pakistan | Maker | Army Navy Retractor, Double End, Set of 2, 8 ½ · Baby Weitlaner Retractor 2 x 3 Prongs Blunt Satin 4'' · Goelet Retractor, Double End 30 x 31 mm and 37 x 40 mm, Satin 7 1/2'' · Weitlaner Retractor 3 x 4 Prongs Blunt Satin 5 1/2" · +1 | — | — |
| Guangzhou Xinuo Technology Co., Ltd | China | Maker | Cheek Retactor;mouth Opener;lip Retractor | — | — |
| Jiangsu Yabaobao Medical Instrument Co.,Ltd. | China | Maker | Cheek retractor | — | — |
| Maryam Trading | Pakistan | Maker | MARYAM TRADING · Multi · RETRACTOR, ALL TYPES | — | — |
| Xiamen Yizhou Imp. & Exp. Co., Ltd. | China | Maker | Cheek Retractor | — | — |
| Shenzhen Senlede Technologies Co., Ltd | China | Maker | Cheek Retactor;mouth Opener;lip Retractor | — | — |
| Towne Brothers (Pvt) Ltd | Pakistan | Maker | RETRACTOR, ALL TYPES | — | — |
| Biopsy Fine Cut Instruments | Pakistan | Maker | RETRACTOR · RETRACTOR, ALL TYPES | — | — |
| Choose Surgical Instruments | Pakistan | Maker | RETRACTOR, ALL TYPES | — | — |
| Gynamed Instruments | Pakistan | Maker | Cloward Retractor Straight, Blade 13mm · Cloward Retractor Straight, Blade 18mm · Cloward Retractor Straight, Blade 20mm · Cloward Retractor Straight, Blade 23mm · +27 | — | — |
| Lohar Medical Company | Pakistan | Maker | EIG / RETRACTOR, ALL TYPES | — | — |
| Nanchang White Technology Co., Ltd. | China | Maker | Cheek Retractor/Mouth Opener/Lip Retractor | — | — |
| Acme Commercial Ways Ltd. | Pakistan | Maker | Retractors | — | — |
| Medline Industries, LP | United States | Maker | Medline Retractor | — | — |
| Nadir & Co. | Pakistan | Maker | Retractors | — | — |
| Y. Z. Corporation | Pakistan | Maker | YZ Retractors | — | — |
| Astar Orthodontics Inc | China | Maker | check retractor, big · check retractor, medium · check retractor, small | — | — |
| Daddy D Pro | Pakistan | Maker | Retractors, Farabeauf Retractors, Langenback Retractors · Retractors, Farabeauf Retractors, Langenback Retractors, Volmann Retractors, Balfour Abdominal Retractors | — | — |
| Mount Blonck Trading | Pakistan | Maker | Breisky retractor,blades 6.5' long x1.5'wide , premium · Cloward type retractor, 6.75', Self-Retaining , with 10 blades , premium · RETRACTOR, ALL TYPES · Weitlaner Retractor , Seff retaining · +5 | — | — |
| Teleflex | United States | Maker | PILLING · RETRACTOR | — | — |
| Nopa Instruments Medizintechnik GmbH | Germany | Maker | RETRACTOR | — | — |
| Surjex | Pakistan | Maker | RETRACTOR OF ALL TYPES | — | — |
| Zhejiang Jasmine Oralcare Products Co., Ltd. | China | Maker | Comfort Soft Large · Comfort Soft Small · Mouth Mate · Tongue-Guide Infant Home · +2 | — | — |
| Dimeda Instrumente GmbH | Germany | Maker | DIMEDA | — | — |
| Pilotis Tech LLC | United States | Maker | Intrace USA | — | — |
| B. Braun Medical Industries Sdn. Bhd | Malaysia | Maker | Retractor | — | — |
| HILBRO International (Pvt) Ltd. | Pakistan | Maker | RETRACTOR · Retractor all types | — | — |
| Ekong Technology Co., Limited. | China | Maker | Cheek Retractor; Mouth Opener; Lip Retractor | — | — |
| Hangzhou Wise Medical Device Co.,Ltd | China | Maker | Retractor Orthodontic (All Type retractors) | — | — |
| Mian Shahid Corp. | Pakistan | Maker | RETRACTOR, ALL TYPES | — | — |
| CDM Center of Excellence Ltd. | China | Maker | Retractor, All Types | — | — |
| LLRN Personal Care (Shenzhen) Co.,ltd | China | Maker | Cheek Retractor/Mouth Opener/Lip Retractor | — | — |
| Tecomet | United States | Maker | PFR | — | — |
| Hefei Mlush Sanitary Products Co., Ltd | China | Maker | Cheek Retractor | — | — |
| Jiangxi Ushine Bright Medical Co., Ltd. | China | Maker | Cheek Retractor/Mouth Opener | — | — |
| M.M Dental Corp | Pakistan | Maker | Retractors | — | — |
| SGS Export Intl. | Pakistan | Maker | — | — | — |
| Spartech Instruments & Co. | Pakistan | Maker | RETRACTOR | — | — |
| Changzhou IVORIE Shengmei Packaging Technology Co.Ltd | China | Maker | Cheek Retractor/Mouth Opener/Lip Retractor | — | — |
| Dr Frigz International Pvt Ltd | Pakistan | Maker | ALL TYPES OF RETRACTORS | — | — |
| Melpex Beauty Instruments | Pakistan | Maker | RETRACTOR, ALL TYPES | — | — |
| Armatech International | Pakistan | Maker | Retractors of all types | — | — |
| Sabokay Industries | Pakistan | Maker | Retractor, All Types | — | — |
| Tianjin Water Source Tech Co., Ltd. | China | Maker | Retractors, Cheek Retractors | — | — |
| Armor Dental Corporation | United States | Maker | Comfort Soft Large · Comfort Soft Small · Mouth Mate® · Tongue-Guide Infant Home · +2 | — | — |
| Darleys Surgical Co. | Pakistan | Maker | RETRACTOR, ALL TYPES | — | — |
| Fuzhou Delphin Bio-tech Co., Ltd. | China | Maker | Cheek retractor | — | — |
| Hazel Enterprises | Pakistan | Maker | RETRACTOR, ALL TYPES | — | — |
| Surgikare | Pakistan | Maker | RETRACTOR, ALL TYPES | — | — |
| T.A. Walthem & Company | Pakistan | Maker | RETRACTOR, ALL TYPES | — | — |
| Washington Surgical International | Pakistan | Maker | RETRACTOR, ALL TYPES | — | — |
| Diligent Medical Ser | Pakistan | Maker | ALM Ret. 3.50¿ B/B STN · RETRACTOR, ALL TYPES · Richardson Ret. 10¿ · Sen-Miller Ret. 6.25¿ B/B Polish · +7 | — | — |
| Gesco Healthcare Private Limited | India | Maker | GESCO | — | — |
| Heyuan Hey White Technology Co., Ltd. | China | Maker | check retractor | — | — |
| Infirmary Medical Supplies | Pakistan | Maker | RETRACTOR, ALL TYPES | — | — |
| Madina Surgical Works | Pakistan | Maker | RETRACTOR, ALL TYPES | — | — |
| Plasdent Shanghai Co., Ltd. | China | Maker | Retractors, Cheek Retractors | — | — |
| S.R.R. Surgical Co | Pakistan | Maker | Abdominal Retractors · Chin Retractor · Non-sterile single use surgical retractors · Retractors · +3 | — | — |
| Alvi Expo | Pakistan | Maker | RETRACTOR, ALL TYPES | — | — |
| Changsha Easyinsmile Intelligence Technology Co.,Ltd. | China | Maker | Mouth opener | — | — |
| Hexamed Pvt Ltd | Pakistan | Maker | Dental Retractor | — | — |
| Nawaz and Sons | Pakistan | Maker | EIG / RETRACTOR, ALL TYPES | — | — |
| Ghousia Amanat Surgical | Pakistan | Maker | Weitlaner Retractor 5.5" · Weitlaner Retractor 5.5" Blunt 3x4 Teeth | — | — |
| Guangxi Ehall Medical Technology Co.,Ltd | China | Maker | Cheek Retractor, Silicone Cheek Retractor | — | — |
| Jiangsu Province Yangzhou Shuguang Toothbrush Manu | China | Maker | LIP PROTECTOR · RETRATORS | — | — |
| Karl Hammacher GmbH | Germany | Maker | Karl Hammacher GmbH | — | — |
| Laparomed Private Limited | India | Maker | CHEEK RETRACTORS | — | — |
| Sabri Industries | Pakistan | Maker | RETRACTOR, ALL TYPES | — | — |
| Shengiho Enterprise Co., Ltd. | Taiwan | Maker | Retractors, Cheek Retractors | — | — |
| Win Wings Corp. | Pakistan | Maker | RETRACTOR, ALL TYPES | — | — |
| Zepf Medical Instrum | Germany | Maker | RETRACTOR | — | — |
| CM Instrumente GmbH | Germany | Maker | — | — | — |
| Concise Enterprises | Pakistan | Maker | — | — | — |
| Mts Brothers Surgical Instruments | Pakistan | Maker | JACKSON BURROWS RETRACTOR · SELF RETAINING. 175 MM | — | — |
| NR Surgical Company | Pakistan | Maker | FREER ELEVATOR | — | — |
| Robinson Healthcare Limited | United Kingdom | Maker | Instrapac | — | — |
| Sino Ortho Limited | China | Maker | Cheek Retractor, Lip Retractor, Lateral Retractor, double side retractors, Lip depressors | — | — |
| Tontarra Medizintechnik GmbH | Germany | Maker | HOEN RETRACTOR | — | — |
| Asanus Medizintechnik GmbH | Germany | Maker | ASANUS | — | — |
| SITEC (Pvt.) Ltd. | Pakistan | Maker | Dental Retractors | — | — |
| Power Dental USA | United States | Maker | — | — | — |
| Shalatco (Pvt) Ltd | Pakistan | Maker | Eye retractors | — | — |
| Greens Surgicals Private Limited | India | Maker | Dr. Vinay Kumar | — | — |
| Shenzhen Mold and Manufacturing Co Ltd | China | Maker | Retractor | — | — |
| Swengg Co | Pakistan | Maker | General Surgery Retractors | — | — |
| Taizhou Polus Technology Co., Ltd. | China | Maker | BEYOND FlexiPro Cheek Retractor (5 pack) (BY-M015) · BEYOND FlexiPro Cheek Retractor (Single pack) (BY-M016) · BEYOND® FlexiBlue® Comfort Cheek Retractor (5 pack L Size) (BY-PD01205L) · BEYOND® FlexiBlue® Comfort Cheek Retractor (5 pack M Size) (BY-PD01205M) · +1 | — | — |
| Glorious Mercantile Corp. (Pvt.) Ltd. | Pakistan | Maker | RETRACTOR, ALL TYPES | — | — |
| Quality Concept (Pvt.) Ltd. | Pakistan | Maker | RETRACTOR, ALL TYPES | — | — |
| Weldon Instruments | Pakistan | Maker | EIG / RETRACTOR, ALL TYPES | — | — |
| Dufner Instrumente GmbH | Germany | Maker | RETRACTOR, ALL TYPES | — | — |
| GLO Science, Inc. | United States | Maker | GLO Retractor | — | — |
| Indusbello Ind. e Com. de Prod. Med. e Odont. Ltda. | Brazil | Maker | INDUSBELLO | — | — |
| Jay-Med | Pakistan | Maker | RETRACTOR, ALL TYPES | — | — |
| Skill To Tech International | Pakistan | Maker | RETRACTOR, ALL TYPES | — | — |
| Stomed Corp. | Pakistan | Maker | RETRACTOR, ALL TYPES | — | — |
| Alta Smiles, Inc | United States | Maker | V5X | — | — |
| Cynosure LLC | United States | Maker | SELF SPAN CHEEK AND LIP RETRACTORS | — | — |
| Endonest Medical Systems LLP | India | Maker | Balfour Retractor, EndoNest All types Retractors (EN21-806)(EN21-807) · EndoNest RETRACTOR, EndoNest ALL TYPES (Liver Ratractor, Nathanson Retractor, EndoNest Thomson Retractor · EndoNest Snake Retractor,Fan Retractors) (EN801-100), en81-1002,EN21-801,EN21-804,EN21-805) | — | — |
| J&J Instruments | United States | Maker | — | — | — |
| NN Inc Power Solutions | United States | Maker | RETRACTOR, ALL TYPES | — | — |
| DongGuan JunHai Medical Device Co., Ltd | China | Maker | Retractor | — | — |
| Julius Wirth | United States | Maker | — | — | — |
| Mecmed Medical | Pakistan | Maker | Retractor all types | — | — |
| Myka Sons & Co | Pakistan | Maker | RETRACTOR, ALL TYPES | — | — |
| Pak Tools Surgical Instruments | Pakistan | Maker | RETRACTOR | — | — |
| QSA Surgical | Pakistan | Maker | ALL TYPES (MULTIPLE BRANDS) · RETRACTOR | — | — |
| Vago International Manufacturing SA DE CV | Mexico | Maker | Umbrella Cheek Retractor | — | — |
| IAA Surgical Instruments Co | Pakistan | Maker | Retractor | — | — |
| Kohler Medizintechnik GmbH | Germany | Maker | — | — | — |
| Princeton Medical Group, Inc. | United States | Maker | Princeton | — | — |
| STONE Instruments company | Pakistan | Maker | RETRACTOR, ALL TYPES | — | — |
| Varco International | Pakistan | Maker | EIG / RETRACTOR, ALL TYPES | — | — |
| Flavio Medicos | Pakistan | Maker | Retractor | — | — |
| ITM Industria de Tecnologias Medicas LTDA | Brazil | Maker | Retractor | — | — |
| Kazan Medical Instruments Plant Joint Stock Compan | Russia | Maker | Retractor TL0088.1 | — | — |
| T33 Dental Inc. | United States | Maker | Rheyo Retractor | — | — |
| Tecno Instruments (Pvt) Ltd. | Pakistan | Maker | RETRACTOR | — | — |
| GATE DENTAL SERVICES LTD ( T/A DentalOrganiser) | Ireland | Maker | Spandex Advanced | — | — |
| Lenox-Maclaren Surgical Corp. | United States | Maker | LENOX MACLAREN | — | — |
| Madhi Corporation | Pakistan | Maker | RETRACTOR | — | — |
| Sanctuary Health Sdn Bhd | Malaysia | Maker | Sanctuary ComfiTract Latex- Free Cheek Retractor | — | — |
| SUBAN Instruments Germany GmbH | Germany | Maker | — | — | — |
| Viant Medical, LLC | United States | Maker | Invisalign Cheek Retractor | — | — |
| Forefront (Xiamen) Medical Devices Co., Ltd. | China | Maker | — | — | — |
| Hermann Mueller Medizintechnik GmbH | Germany | Maker | — | — | — |
| IsoRetract LLC | United States | Maker | ISORETRACT | — | — |
| Phoenix Instruments, Inc. | United States | Maker | — | — | — |
| proNet, A Desco Industries Inc. Brand | United States | Maker | CHEEK RETRACTOR | — | — |
| Retract EEZ, Inc. | United States | Maker | Photographic Lip Retractor | — | — |
| Talent Technology Mould Co., Limited | China | Maker | Xerosguard | — | — |
| Taurus Engineering and Manufacturing, Inc. | United States | Maker | — | — | — |
| The Cretex Companies, Inc. | United States | Maker | — | — | — |
| Wenzhou Caretek Medical Device Co., Ltd | China | Maker | Retractor | — | — |
| Xerosguard Inc. | Canada | Maker | Xerosguard | — | — |
| Xinhua Surgical Instrument Co.,Ltd. | China | Maker | — | — | — |
| A. Handte Medizintechnik GmbH & Co. KG | Germany | Maker | — | — | — |
| Avalanche Med Sdn Bhd | Malaysia | Maker | — | — | — |
| Avalign Technologies | United States | Maker | — | — | — |
| Baeramed Instrumente | Germany | Maker | — | — | — |
| Denzel Medical GmbH & Co. KG | Germany | Maker | — | — | — |
| Devemed GmbH | Germany | Maker | — | — | — |
| Eltek Instruments (Pvt.) Ltd. | Pakistan | Maker | — | — | — |
| Erchinger | Germany | Maker | — | — | — |
| G. Hipp & Sohn GmbH | Germany | Maker | — | — | — |
| Gebrueder Zepf | Germany | Maker | — | — | — |
| Helmut Zepf Medizintechnik GmbH | Germany | Maker | — | — | — |
| HGR Instrumente GmbH | Germany | Maker | — | — | — |
| Jaffrose International | Pakistan | Maker | — | — | — |
| KAPP Surgical GmbH | Germany | Maker | — | — | — |
| Max Hauser Suddeutsche Chirurgie-Mechanik GmbH | Germany | Maker | — | — | — |
| MICROMA Martin Alber GmbH & Co. KG | Germany | Maker | — | — | — |
| Nextcon International | Pakistan | Maker | — | — | — |
| Pacific Instruments, Inc. | United States | Maker | — | — | — |
| PMS GmbH | Germany | Maker | — | — | — |
| REDA Instrumente GmbH | Germany | Maker | — | — | — |
| Richard Wolf GmbH | Germany | Maker | — | — | — |
| Sinntech Medical (Private) Limited | Pakistan | Maker | — | — | — |
| Stengelin Medical | Germany | Maker | — | — | — |
| Tekno-Medical Optik-Chirurgie GmbH | Germany | Maker | — | — | — |
| Track of Surgical | Pakistan | Maker | — | — | — |
| Wise Instruments | Pakistan | Maker | — | — | — |
| 奥古斯特罗兰有限公司August Reuchlen GmbH | Germany | Maker | — | — | — |
| Kulzer, LLC | United States | Contract manufacturer | — | 37 | 2026 |
| B.t.i. Biotechnology | Spain | Foreign exporter | — | 14 | 2024 |
| American Orthodontics | United States | Contract manufacturer | American Cheek Retractors · Clear Cheek Retractors | 44 | 2026 |
| Young Innovations Inc | United States | Contract manufacturer | Cheek Retractor · Defend Lite · **DISPOSABLE**CK-X-PANDER | 23 | 2025 |
| Park Dental Research Corp | United States | Contract manufacturer | Cheek Retractor/Mouth Opener/Lip Retractor | 8 | 2026 |
| Dentamerica | United States | Repacker / relabeler | POLYTRACTOR | 4 | 2010 |
| Suncoast Dental Corp. | United States | Repacker / relabeler | Rongeur | 2 | 1981 |
| Aesculap, Inc. | United States | Lister | Aesculap | 2 | 2006 |
| George Taub Products & Fusion Co., Inc. | United States | Manufacturer | Mouth Gag - Molt · Trident - Mouth Props | 2 | 1986 |
| DB Orthodontics Limited | United Kingdom | Foreign exporter | DB Orthodontics Retractors | 2 | 2010 |
| Rmo, Inc. | United States | Manufacturer | Cheek Retractor | 1 | 1990 |
| Sotera Health LLC | United States | Contract manufacturer | — | — | — |
| Jersey Dental Supplies | United States | Repacker / relabeler | OPALDAM · OPTRAGATE | — | — |
| Dentimed Sao Joao LLC | United States | Repacker / relabeler | ANGELUS | — | — |
| TitanLinks Logistics LLC | United States | Repacker / relabeler | retractor | — | — |
| Jmu Dental, Inc. | United States | Repacker / relabeler | C-type cheek retractor | — | — |
| Patterson Companies, Inc. | United States | Foreign exporter | Retractor | — | — |
| STERIS Corporation | United States | Contract sterilizer | V. Mueller Open Retractors (ST-CFE) | — | — |
| Practicon, Inc. | United States | Manufacturer | C Type Cheek Retractor · C Type Winged Cheek Retractor · Lip Retractor · Y Type Cheek Retractor | — | — |
| Summit Orthodontic Services, Inc. | United States | Repacker / relabeler | Clinipix Retractor · Extra-oral Cheek Expander · Lip & Cheek Retractor · Nola · +8 | — | — |
| International Orthodontics Services. PC | United States | Repacker / relabeler | Cheeck Retractor · Nola Dry field | — | — |
| Premium Plus Dental | United States | Lister | Premium Pl;us Mouth Retractor | — | — |
| Ortho Arch Company Inc | United States | Repacker / relabeler | Photo Lip Retractor, Double Ended Lip Retractor, Expando Cheek Retractor, Access Cheek Retractor, Lip Retractor | — | — |
| Csy International LLC | United States | Repacker / relabeler | J&J ORTHODONTICS | — | — |
| GoldenDent | United States | Repacker / relabeler | SeeMore | — | — |
| PDT Inc. | United States | Contract manufacturer | — | — | — |
| Yizur Ltd | Hong Kong SAR China | Foreign exporter | Prop | — | — |
| Wise Linkers LLC | United States | Repacker / relabeler | Artman Instruments | — | — |
| LLD Care d.o.o. | Croatia | Foreign exporter | Retractor | — | — |
| Sklar Corporation | United States | Repacker / relabeler | Retractor | — | — |
| Unisource Shanghai Ltd. | China | Foreign exporter | Comfort Soft Large · Comfort Soft Small · Mouth Mate · Tongue-Guide Infant Home · +2 | — | — |
| First Dental Supplies LLC | United States | Repacker / relabeler | RETRACTOR, ALL TYPES | — | — |
| Ortho Dental Lab, LLC | United States | Manufacturer | SmileSet Cheek Retractor | — | — |
| Maxill Inc. | United States | Foreign exporter | Cheek Retractors (Extraoral, Intraoral, Lip & Cheek, Single/Double Sided Hand Held) | — | — |
| Beaming White LLC | United States | Manufacturer | Retractor | — | — |
| YCH Distripark Sdn Bhd | Malaysia | Foreign exporter | Retractor | — | — |
| Plasdent Corporation | United States | Repacker / relabeler | Cheek Retractors, Props, Retractor-all types | — | — |
| Candid Care Co. | United States | Contract manufacturer | Candid Cheek Retractor · ScanBox Pro | — | — |
| Esthetic Orthodontic Company of America LLC | United States | Repacker / relabeler | Buccal cheek retractor | — | — |
| Bina Limited | Belize | Foreign exporter | RETRACTOR | — | — |
| WSD Labs Usa Inc. | United States | Repacker / relabeler | Cheek Retractor/Mouth Opener/Lip Retractor | — | — |
| Sontec Instruments Inc | United States | Repacker / relabeler | ALL TYPES OF RETRACTORS | — | — |
| Peak Implements Inc | United States | Repacker / relabeler | RETRACTOR, ALL TYPES | — | — |
| Sanicure BV | Netherlands | Foreign exporter | — | — | — |
| Zapalign LLC | United States | Repacker / relabeler | — | — | — |
| Oriental International Supplies Limited | Hong Kong SAR China | Foreign exporter | Orthodontic, Cheek Retractor | — | — |
| ambler surgical | United States | Repacker / relabeler | Ambler | — | — |
| Peter Brasseler Holdings, LLC | United States | Contract manufacturer | — | — | — |
| SurgiPros LLC | United States | Repacker / relabeler | SURGIPROS | — | — |
| Evolve Dental Technologies, Inc. | United States | Repacker / relabeler | KöR Dam | — | — |
| Hangzhou HaiZhu MIM products Co., Ltd | China | Foreign exporter | RETRACTOR | — | — |
| Med Saver, Inc. | United States | Repacker / relabeler | MSI Precision Specialty Instruments | — | — |
| simex Medizintechnik GmbH | Germany | Repacker / relabeler | Retractor, All Types | — | — |
| Boss Instruments Ltd | United States | Repacker / relabeler | Boss Dental Retractors | — | — |
| George Tiemann & Co. | United States | Repacker / relabeler | Retractor, General Tiemann | — | — |
| HNM Medical | United States | Repacker / relabeler | HNM Medical Surgical Instrument | — | — |
| Cambrian Medical, Inc. | United States | Repacker / relabeler | cambrian medical | — | — |
| Novo Surgical Inc. | United States | Repacker / relabeler | Novo Surgical Retractor, All Types | — | — |
| Adler Instruments | United States | Repacker / relabeler | Adler | — | — |
| Reset Technology Corporation | United States | Repacker / relabeler | Reset Impression Kit | — | — |
| Beyond International Inc. | United States | Manufacturer | BY-M015 BEYOND® FlexiPro Cheek Retractor (5 Pack) · BY-M016 BEYOND® FlexiPro Cheek Retractor (Single Pack) | — | — |
| Hayden Medical | United States | Repacker / relabeler | University of Minnesota Cheek Retractor | — | — |
| LSL Healthcare | United States | Repacker / relabeler | RETRACTOR, ALL TYPES | — | — |
| Olulo LLC | United States | Repacker / relabeler | — | — | — |
| 3D Dental Designs and Development LLC | United States | Contract manufacturer | — | — | — |
| DJ Acquisition FTT, LLC | United States | Repacker / relabeler | — | — | — |
| Mainline Medical Dental Supply | Canada | Foreign exporter | — | — | — |
| Oketz Logistics LLC | United States | Repacker / relabeler | — | — | — |
| Premier Online Exodontia Courses, Inc. | Canada | Foreign exporter | — | — | — |
| Swedent Dental Wholesale Group | United States | Repacker / relabeler | — | — | — |
| Vehu Medical Instrumente GmbH | Germany | Repacker / relabeler | — | — | — |
| Wexler Surgical Inc. | United States | Repacker / relabeler | — | — | — |
| Wise Instruments Inc | United States | Repacker / relabeler | — | — | — |
510(k) clearances
| Decided | 510(k) | Device | Applicant |
|---|---|---|---|
| 3 Jun 1997 | K971284 | OPALDAM | Ultradent Products, Inc. |
| 25 Feb 1986 | K854711 | FIBRELIGHT ILLUMINATING ORAL RETRACTORS | Downs Surgical , Ltd. |
| 26 Sep 1983 | K832366 | ZOLLER BURNED LIP CONFORMER | Universal Prosthetics, Inc. |
| 6 Jul 1982 | K821784 | BEACH GINGIVAL RETRACTION INSTR. TYPE B | Pacific Dental Corp. |
| 7 Nov 1977 | K771973 | GINGITRACT | Den-Mat Corp. |
| 26 Aug 1977 | K771399 | LIP & CHEEK RETRACTOR | L.D. Caulk Co. |
| 19 Nov 1976 | K761024 | RACESTYPTINE RINGS | Septodont |
| 27 Sep 1976 | K760657 | RACESTYPTINE CORD | Septodont |
Official records: FDA product classification for EIG · 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