Rubber dam systems: manufacturers and brands
181 companies make or specify rubber dams among the 232 that list one with FDA, under 820 brand and model names. FDA has issued 40 510(k) clearances in this category, 0 of them in the last five years.
510(k) clearances per year, 1976–2026
Rubber dam 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 |
|---|---|---|---|---|---|
| Mediclus Co., Ltd | South Korea | Maker | Dentto-Dam | 15 | 2026 |
| Spident Co., Ltd. | South Korea | Maker | FineDam | 22 | 2026 |
| GC America Inc. | United States | Maker | GC Conditioner · GC TiON Gingival Protector | 137 | 2026 |
| Sybron Dental Specialties | United States | Maker | SoftClamp | 203 | 2026 |
| Ultradent Products, Inc. | United States | Maker | OralSeal Kit · OralSeal Putty · OraSeal Caulking | 95 | 2026 |
| Kulzer, LLC | United States | Maker | IVORY RUBBER DAM CLAMP · Ivory Rubber Dam Complete Kit · IVORY RUBBER DAM INTRO KIT · Ivory Rubber Dam Starter Kit · +6 | 37 | 2026 |
| Ivoclar Vivadent, AG | United States | Maker | OptraDam Plus | 94 | 2026 |
| Inter-Med, Inc. | United States | Maker | Blue Gingival Barrier · Liquid Dam | 7 | 2026 |
| Dent4You AG | Switzerland | Maker | HySolate Brinker Dental Dam Clamp · HySolate Dental Dam Clamp · HySolate Fiesta Dental Dam Clamp · HySolate Dental Dam · +3 | 5 | 2026 |
| Young Innovations Inc | United States | Maker | RUBBER DAM HOLDER | 23 | 2025 |
| Sdi Limited | Australia | Maker | — | 8 | 2022 |
| Guilin Kevin Peter Technology Co., Ltd. | China | Maker | Light Cured Gingival Barrier · Rubber Dam | 3 | 2026 |
| Dentscare Ltda | Brazil | Maker | TOP DAM 1G · TOP DAM 2G | 10 | 2024 |
| Dentalez, Inc. | United States | Maker | Visi-Frame | 9 | 2026 |
| Den-Mat Holdings, LLC | United States | Maker | Edge Dam · Paint-On Dental Dam · True Dental Dam | 8 | 2026 |
| Premium Plus (Dongguan) Limited | China | Maker | Rubber dam frame | 2 | 2025 |
| HDI Inc. | South Korea | Maker | Denu Dam · Denu Fil Flow | 2 | 2022 |
| Beijing C-Root Dental Medical Devices Co., LTD. | China | Maker | C-Root Dam · C-Root Leak Seak · C-Root Leak Seal (blue) | 2 | 2024 |
| Smart Denture Conversions, LLC | United States | Maker | — | 2 | 2026 |
| Coltene/Whaledent AG | Switzerland | Maker | Hygenic® Dental Dam Kits · Hygenic® Elasti-Dam · Hygenic® Fiesta® Dental Dam · Hygenic® Flexi Dam · +12 | 45 | 2022 |
| DMG Chemisch-Pharmazeutische Fabrik GmbH | Germany | Maker | DMG MiniDam · DMG MiniDam 100x · DMG MiniDam 20x USA · DMG MiniDam Sample | 4 | 2022 |
| Garrison Dental Solutions LLC | United States | Maker | Band and Wedge Instrument · Composi-Tight® · NiTin · 3D Fusion | 3 | 2024 |
| Shinhung Company, Ltd. | South Korea | Maker | K-CLAMP | 2 | 2023 |
| Shenzhen Rogin Medical Co., Ltd. | China | Maker | Dental Dam Clamp Tray, · Dental Dam Clamp, Dental Dam Punch, Dental Forceps, · Dental Dam Frame, Dental Dam Heavy, · Dental Dam Punching Template, · +3 | 1 | 2025 |
| Pulpdent Corporation | United States | Maker | KOOL-DAM · PCA "DAM" FRAME | 107 | 2021 |
| Aseptico, Inc. | United States | Maker | K-0 - RUBBER DAM CLAMP BICUSPID #0 · K-00 - RUBBER DAM CLAMP BICUSPID #00 · K-1 - RUBBER DAM CLAMP BICUSPID #1 · K-12A - RUBBER DAM CLAMP MOLAR #12A · +59 | 17 | 2015 |
| Philips Medical Systems International BV | Netherlands | Maker | Liquidam | 16 | 2010 |
| The Hygenic Company, LLC | United States | Maker | Elasti-Dam · Fiesta Dental Dam · Flexi Dam Non-Latex · Framed Flexi Dam Non-Latex · +3 | 13 | 1996 |
| Angelus Industria DE Produtos Odontologicos S/A | Brazil | Maker | OSTBY FRAME · RUBBER DAM FRAME | 11 | 2021 |
| Prime Dental Manufacturing, Inc. | United States | Maker | Dental Dam · Light Cure Soft Dental Dam · Prime Blend Ultra · Prime-Paste | 9 | 2012 |
| Medicon EG | Germany | Maker | — | 9 | 2005 |
| Hu-Friedy Mfg Co., LLC | United States | Maker | Hu-Friedy Mfg Co.,LLC · Rubber Dam Frame | 8 | 2012 |
| Integra LifeSciences Corporation | United States | Maker | Integra · Integra Miltex · Miltex · Padgett | 2 | 2014 |
| Storz AM Mark GmbH | Germany | Maker | Rubber dam clamp · Rubber dam clamp forceps · Rubber dam punch | 2 | 2008 |
| Dental Technologies, Inc. | United States | Maker | GINGIVAL DAM MATERIAL | 2 | 2013 |
| Manufacturera Dental Continental | Mexico | Maker | NIC TONE RUBBER DAM · Nic Tone Synthetic Dam · Ready Dam · MDC NIC TONE RUBBER DAM | 2 | 2001 |
| George Taub Products & Fusion Co., Inc. | United States | Maker | — | 2 | 1986 |
| Denali R & D Corporation | United States | Maker | Triumph | 2 | 2009 |
| Dfl Industria E Comercio SA | Brazil | Maker | KS Dent | 2 | 2013 |
| B&L Biotech Co., Ltd. | South Korea | Maker | Rubber Dam · CLAMP1 · CLAMP12A · CLAMP13A · +3 | 1 | 2006 |
| Abracadabra Implants Ltd. | Israel | Maker | RRD - Round Rubber Dam | 1 | 2021 |
| Directa AB | Sweden | Maker | DRY-DAM · RAINBOW DENTAL RUBBER DAM & PUNCH · RAINBOW RUBBER DAM FRAME | 1 | 2015 |
| COLTENE Holding AG | Switzerland | Maker | HySolate Flexi Dam | 1 | 2003 |
| Bioseal | United States | Maker | Sheet Silastic | 1 | 1988 |
| Osung Mnd Co Ltd | South Korea | Maker | RDC2 · RDC201 · RDC202 · RDC203 · +23 | — | — |
| TOR VM Ltd. | Russia | Maker | Cat.#0 Clamp · Cat.#0-B Clamp · Cat.#00 Clamp · Cat.#00-B Clamp · +135 | — | — |
| ErgoDenta ApS | Denmark | Maker | Ainsworth Rubber Dam Punch, 17cm · G27 - Molar rubber dam clamps (GENERAL) · G27N - Pre molar rubberdam clamps · Ivory Rubber Dam Clamp Forceps, 17cm · +61 | — | — |
| Zain's Medical Image | Pakistan | Maker | RUBBER DAM CLAMP # 0 · RUBBER DAM CLAMP # 00 · RUBBER DAM CLAMP # 1 · RUBBER DAM CLAMP # 2 · +17 | — | — |
| Densol International (Private) Limited | Pakistan | Maker | Rubber Dam Clamp #00 · Rubber Dam Clamp #12A · Rubber Dam Clamp #12A TIT Black · Rubber Dam Clamp #13A · +46 | — | — |
| Schobell Industrial Ltda | Brazil | Maker | Ainsworth Rubber Dam Punch · Ring Spreader Pliers · Rubber Dam Clamp forceps · Rubber Dam Clamp forceps serrated | — | — |
| Signor Seven International | Pakistan | Maker | Ivory-Type Rubber Dam Clamp Forceps SKU 12-1103-E · Ivory-Type Rubber Dam Clamp Forceps, Stainless Steel, Pro Series, 1/Pk SKU 12-1103 · Rubber Dam Kit SKU RDKIT-P · Rubber Dam Punch Ainsworth SKU 12-1101-P | — | — |
| Debo Medical Technology (Shijiazhuang) Co., Ltd. | China | Maker | Dental Dam · Dental Gum Dam · Gingival Protection Gel · Gum Protector Gel · +1 | — | — |
| B. Ali Impex | Pakistan | Maker | AINSWORTH · BALI · DOCTOR NICE · IVERY | — | — |
| Dental Studio | South Korea | Maker | RUBBER DAM FRAME · RUBBER DAM FORCEPS · RUBBER DAM PUNCH | — | — |
| Shenzhen Denco Medical Co Ltd | China | Maker | Dental Dam Clamp Tray, · Dental Dam Frame, Dental Dam Heavy, · Dental Dam Punch, Dental Forceps, · Dental Dam Punching Template, · +3 | — | — |
| Bashir Jamil & Bros. (Pvt.), Ltd. | Pakistan | Maker | RUBBER DAM CLAMP TYPE 0 · RUBBER DAM CLAMP TYPE 00 · RUBBER DAM CLAMP TYPE 1 · RUBBER DAM CLAMP TYPE 12A · +24 | — | — |
| Huanghua Promisee Dental Co., Ltd | China | Maker | Dental Dam Kit · Wedge Floss · Punch · Frame · +1 | — | — |
| Technimen Skillers | Pakistan | Maker | IVORY RUBBER DAM CLAMP · FORCEPS RUBBER DAM CLAMP | — | — |
| Falcon Surgical Co. (Pvt.) Ltd. | Pakistan | Maker | Rubber Dam Clamp · Rubber Dam Frame · Forceps, Rubber Dam Clamp | — | — |
| Pomee Corporation | Pakistan | Maker | Rubber Dam · Rubber Dam Clamp | — | — |
| Commic Surgico | Pakistan | Maker | Ivory Rubber Dam Punch · Rubber Dam clamp · Rubber Dam Forceps · Rubber Dam Punch | — | — |
| Endo Tech Instruments | Pakistan | Maker | Rubber Dam Frame Adult · Rubber Dam Clamp Forceps · Rubber Dam Punch Pliers | — | — |
| Medcave Private Limited | Pakistan | Maker | Rubber Dam Clamp | — | — |
| Panorama International | Pakistan | Maker | Rubber Dam Clamps · FRAME, RUBBER DAM · FORCEPS, RUBBER DAM CLAMP | — | — |
| Accompany Surgical | Pakistan | Maker | Rubber Dam Clamp · Rubber Dam Clamp Forceps · Rubber Dam Clamp Frame · Rubber Dam Punch | — | — |
| Lacigrus International | Pakistan | Maker | CLAMP, RUBBER DAM · FRAME, RUBBER DAM | — | — |
| Comfort Surgical Instruments | Pakistan | Maker | Rubber Dam Clamp · Rubber Dam frame · Rubber Dam forceps | — | — |
| Aesculap AG | Germany | Maker | Aesculap · RUBBER DAM CLAMP FORCEPS | — | — |
| Adolf Schweick Hardt GmbH & Co | Germany | Maker | RUBBERDAM CLAMP FORCEPS | — | — |
| Beyes Dental Inc | Canada | Maker | Dental Rubber Dams | — | — |
| Confident Instruments | Pakistan | Maker | Artman Instruments | — | — |
| Tangshan Zhengtong Exhibition Co., Ltd. | China | Maker | — | — | — |
| Denta Craft Instruments | Pakistan | Maker | Rubber Dam Clamp · Rubber Dam Clamp Forceps; Rubber Dam Clamp Frame; Rubber Dam Punch | — | — |
| ZOGEAR Medical Co., Ltd. | China | Maker | FRAME, RUBBER DAM | — | — |
| Hilbro Instruments (Pvt) Ltd | Pakistan | Maker | CLAMP, RUBBER DAM · HILBRO INSTRUMENTS RUBBER DAM CLAMP | — | — |
| Jiangxi IVISMILE Technology Co.,Ltd | China | Maker | Dental Dam; Dental Gum Dam; Gum Protector Gel; Gingival Protection Gel | — | — |
| Medisporex Private Limited | Pakistan | Maker | CLAMP, RUBBER DAM · RUBBER DAM CLAMP FORCEPS, RUBBER DAM FORCEPS PUNCH · MEDIS | — | — |
| Dentag SRL | Italy | Maker | DENTAG | — | — |
| Suzhou Ramo Medical Instrument Co., Ltd. | China | Maker | Rubber Dam | — | — |
| Garish Apparels | Pakistan | Maker | Tamzon Instruments Inc. | — | — |
| Acme Enterprises | Pakistan | Maker | Rubber Dam Clamp · TBS Dental | — | — |
| Surgicrafts | Pakistan | Maker | EEF / CLAMP, RUBBER DAM | — | — |
| G.A. Surgical (Pvt.) Ltd. | Pakistan | Maker | ENDODONTIC RUBBER DAM CLAMPS | — | — |
| Acheron Instruments (Pvt.) Ltd. | Pakistan | Maker | Rubber Dam Clamp | — | — |
| Hubei Guarddent Medical Technology Co.,Ltd | China | Maker | rubber dam | — | — |
| Silver Plus Corp. | Pakistan | Maker | CLAMP, RUBBER DAM · FORCEPS, RUBBER DAM CLAMP | — | — |
| Surgiscape | Pakistan | Maker | CLAMP, RUBBER DAM | — | — |
| Guangzhou Xinuo Technology Co., Ltd | China | Maker | Dental Dam; Dental Gum Dam; Gum Protector Gel; Gingival Protection Gel; gingival barrier | — | — |
| Maryam Trading | Pakistan | Maker | FORCEPS, RUBBER DAM CLAMP · Maryam Trading · Multi | — | — |
| AMD Medicom Inc | Canada | Maker | Hedy Dental Dam · Medicom Dental Dam | — | — |
| Shenzhen Senlede Technologies Co., Ltd | China | Maker | Dental Dam; Dental Gum Dam; Gum Protector Gel; Gingival Protection Gel; gingival barrier | — | — |
| Towne Brothers (Pvt) Ltd | Pakistan | Maker | EEF - CLAMP, RUBBER DAM · EIE - DAM, RUBBER · EJE - FRAME, RUBBER DAM · EJG - FORCEPS, RUBBER DAM CLAMP | — | — |
| Bioclear Matrix Systems, LLC | United States | Maker | TwinRing Forceps | — | — |
| Biopsy Fine Cut Instruments | Pakistan | Maker | CLAMP · CLAMP, RUBBER DAM | — | — |
| Choose Surgical Instruments | Pakistan | Maker | CLAMP, RUBBER DAM | — | — |
| Jiangxi Dentalbright Technology Co., Ltd | China | Maker | Dental Dam/Dental Gum Dam/ Gum Protector Gel/ Gingival Protection Gel | — | — |
| Lohar Medical Company | Pakistan | Maker | EEF / CLAMP, RUBBER DAM | — | — |
| Mident Ltd | United Kingdom | Maker | Rubber Dam Forceps | — | — |
| Nanchang White Technology Co., Ltd. | China | Maker | Dental Dam/Dental Gum Dam/ Gum Protector Gel/ Gingival Protection Gel | — | — |
| TF New Material Sci and Tec Co.,ltd | China | Maker | Rubber dam | — | — |
| Acme Commercial Ways Ltd. | Pakistan | Maker | Rubber Dam Clamp · Rubber Dam Clamp Forcep | — | — |
| Y. Z. Corporation | Pakistan | Maker | YZ Rubberdam Frame · YZ Rubber Dam Clamp Forceps | — | — |
| Daddy D Pro | Pakistan | Maker | Rubber Dam Clamp | — | — |
| Crown Surgical Corp. | Pakistan | Maker | CROWN ECO · CROSURG | — | — |
| Onvet Medical Canada Inc. | Canada | Maker | Markson Flowdam · SureTact G3, G4, G5,G6,G8® | — | — |
| Surjex | Pakistan | Maker | CLAMP, RUBBER DAM · FORCEPS, RUBBER DAM CLAMP | — | — |
| Dimeda Instrumente GmbH | Germany | Maker | DIMEDA | — | — |
| Pilotis Tech LLC | United States | Maker | Intrace USA | — | — |
| HILBRO International (Pvt) Ltd. | Pakistan | Maker | CLAMP, RUBBER DAM · Forceps, Rubber Dam Clamp · Hilbro Intl Rubber dam clamp forcep | — | — |
| Medesy Srl | Italy | Maker | medesy | — | — |
| Meed Skills Surgical | Pakistan | Maker | Meed Skills Surgical | — | — |
| Ekong Technology Co., Limited. | China | Maker | Dental Dam; Dental Gum Dam; Gum Protector Gel; Gingival Protection Gel | — | — |
| Maquira Industria de Produtos Odontologicos | Brazil | Maker | RUBBER DAM CLAMP | — | — |
| Mian Shahid Corp. | Pakistan | Maker | CLAMP, RUBBER DAM · FORCEPS, RUBBER DAM CLAMP | — | — |
| Svenska Dentorama AB | Sweden | Maker | Dentorama Non-Latex Dam · Dentorama Rubber Dam · VividDam Rubber Latex Dam · DENTORAMA RUBBER DAM FRAME | — | — |
| Zirc Dental Products Inc | United States | Maker | Airway Armor · Latex-Free Insti-Dam Relaxed Fit, Latex-Free Insti-Dam | — | — |
| CDM Center of Excellence Ltd. | China | Maker | Forceps, Rubber Dam Clamp | — | — |
| LLRN Personal Care (Shenzhen) Co.,ltd | China | Maker | Dental Dam/Dental Gum Dam/ Gum Protector Gel/ Gingival Protection Gel | — | — |
| Volgo Care International (Private) Limited | Pakistan | Maker | VOLGOCARE | — | — |
| Huzhou Junda Industry Co., Ltd. | China | Maker | Examination lamp · Facial feature checker | — | — |
| Viarden Lab LLC | United States | Maker | TOTAL DAM | — | — |
| Dentech Corp. | Japan | Maker | CLAMP, RUBBER DAM · Dentech Corporation · FRAME, RUBBER DAM · FORCEPS, RUBBER DAM | — | — |
| Jiangxi Ushine Bright Medical Co., Ltd. | China | Maker | Gum Dam/ Gum Protetcor/Gingival Barrier | — | — |
| Spartech Instruments & Co. | Pakistan | Maker | CLAMP · RUBBER DAM | — | — |
| Changzhou IVORIE Shengmei Packaging Technology Co.Ltd | China | Maker | Dental Dam/Dental Gum Dam/ Gum Protector Gel/ Gingival Protection Gel | — | — |
| Hager & Werken | Germany | Maker | Rubber Dam | — | — |
| Sabokay Industries | Pakistan | Maker | Clamp, Rubber Dam · FRAME, RUBBER DAM | — | — |
| Aesculap Chifa SP. Z O.O. | Poland | Maker | AIMSWORTH · BREWER · FORCEPS, RUBBER DAM CLAMP | — | — |
| Darleys Surgical Co. | Pakistan | Maker | CLAMP, RUBBER DAM | — | — |
| Elite Dental Lab | China | Maker | Rubber Dam Clamp · Rubber Dam · Rubber Dam Frame · Rubber Dam Forceps | — | — |
| Fuzhou Delphin Bio-tech Co., Ltd. | China | Maker | Gum protector gel | — | — |
| Hazel Enterprises | Pakistan | Maker | DENTAL CLAMP ( Tofflimire ) | — | — |
| Shandong Zhushi Pharmaceutical Group Co., Ltd | China | Maker | Dental Dam;Dental Gum Dam;Gum Protector Gel ;Gingival Protection Gel | — | — |
| Surgikare | Pakistan | Maker | CLAMP, RUBBER DAM | — | — |
| T.A. Walthem & Company | Pakistan | Maker | CLAMP, RUBBER DAM | — | — |
| Washington Surgical International | Pakistan | Maker | DENTAL CLAMP ( Tofflimire ) | — | — |
| Heyuan Hey White Technology Co., Ltd. | China | Maker | Gum health serum · Gum protector | — | — |
| Infirmary Medical Supplies | Pakistan | Maker | CLAMP, RUBBER DAM | — | — |
| Madina Surgical Works | Pakistan | Maker | FORCEPS, RUBBER DAM CLAMP | — | — |
| Alvi Expo | Pakistan | Maker | FORCEPS, RUBBER DAM CLAMP | — | — |
| Hexamed Pvt Ltd | Pakistan | Maker | Rubber Dam Clamp · Rubber Dam Clamp Forceps | — | — |
| Nawaz and Sons | Pakistan | Maker | EEF - CLAMP, RUBBER DAM | — | — |
| Karl Hammacher GmbH | Germany | Maker | Karl Hammacher GmbH | — | — |
| Laparomed Private Limited | India | Maker | RUBBER DAM INSTRUMENTS (FRAME, CLAMPS, PUNCH, FORCEP KIT) | — | — |
| Sabri Industries | Pakistan | Maker | CLAMP, RUBBER DAM | — | — |
| Zepf Medical Instrum | Germany | Maker | FORCEPS · RUBBER DAM CLAMP | — | — |
| CM Instrumente GmbH | Germany | Maker | CM -Instrumente · CM RUBBER DAM AND ACCESSORIES | — | — |
| NR Surgical Company | Pakistan | Maker | CLAMP, RUBBER DAM | — | — |
| ASA Dental | Italy | Maker | Rubber Dam Clamp | — | — |
| Power Dental USA | United States | Maker | FORCEPS, RUBBER DAM CLAMP | — | — |
| PHS Do Brasil LTDA | Brazil | Maker | POTENZA BLOCCO | — | — |
| Swengg Co | Pakistan | Maker | Rubber Dam Clamp / punches | — | — |
| Empire Surgical Instruments Company | Pakistan | Maker | EMPSURG | — | — |
| Four D Rubber Co Ltd | United Kingdom | Maker | ISOLATE · Latex BIODAM · Latex ISODAM · Latex Isotex Oral Barrier · +4 | — | — |
| GLO Science, Inc. | United States | Maker | GLO Dam | — | — |
| J&J Instruments | United States | Maker | — | — | — |
| Mexpo International Inc | United States | Maker | BLOSSOM · DISCOVERY2020 · FRUTTI TREASURE · GENTOUCH · +2 | — | — |
| Julius Wirth | United States | Maker | Hu-Friedy | — | — |
| IPB Inc | United States | Maker | — | — | — |
| Kohler Medizintechnik GmbH | Germany | Maker | — | — | — |
| T33 Dental Inc. | United States | Maker | Rheyo Flex Barrier | — | — |
| Beyond International Inc. | United States | Maker | — | — | — |
| Crimson International | Pakistan | Maker | FORCEPS, RUBBER DAM CLAMP | — | — |
| Sanctuary Health Sdn Bhd | Malaysia | Maker | — | — | — |
| Hoogland Spine Products GmbH | Germany | Maker | sealing cap | — | — |
| Jiangmen Ronghai Medical Technology Co., Ltd. | China | Maker | Rubber Dam Sheet, Dental Dam Sheet | — | — |
| Jiangsu Rude Medical Apparatus and Instrument Co. Ltd. | China | Maker | UNIVERSAL FORCEPS | — | — |
| Phoenix Instruments, Inc. | United States | Maker | — | — | — |
| QUALITY LATEX PRODUCTS (PVT) Ltd. | United States | Maker | Latex dam | — | — |
| Shenzhen Yimi Care Technology Co.,ltd | China | Maker | frame, rubber dam | — | — |
| USTOMED INSTRUMENTE GmbH & Co. KG | Germany | Maker | — | — | — |
| Devemed GmbH | Germany | Maker | — | — | — |
| Elmed Instruments (Pvt) Ltd | Pakistan | Maker | — | — | — |
| Geomed Medizin-Technik GmbH & Co | Germany | Maker | — | — | — |
| Gulmag International | Pakistan | Maker | — | — | — |
| Helmut Zepf Medizintechnik GmbH | Germany | Maker | — | — | — |
| Nextcon International | Pakistan | Maker | — | — | — |
| RZ Medizintechnik GmbH | Germany | Maker | — | — | — |
| Sinntech Medical (Private) Limited | Pakistan | Maker | — | — | — |
| Tekno-Medical Optik-Chirurgie GmbH | Germany | Maker | — | — | — |
| TG Medical Sdn Bhd | Malaysia | Maker | — | — | — |
| Zest Anchors, LLC | United States | Manufacturer | — | 26 | 2026 |
| Premier Dental Products Company | United States | Contract manufacturer | FORCEPS · RUBBER DAM CLAMP | 28 | 2026 |
| Pac-Dent Inc. | United States | Contract manufacturer | — | 5 | 2022 |
| Keystone Industries | United States | Contract manufacturer | Prehma Rubber Dam | 2 | 2025 |
| DSI Dental Solutions Ltd | Israel | Manufacturer | Unilite Dam Liquid LC Material | 2 | 2025 |
| Elastomade Accessories Sdn Bhd | Malaysia | Lister | Dental Dam · Royal Shield Latex Free Dental Dam | 3 | 1995 |
| Hager Worldwide, Inc. | United States | Manufacturer | Plast Frame | 2 | 2005 |
| Aesculap, Inc. | United States | Lister | Aesculap | 2 | 2006 |
| Dharma Research, Inc. | United States | Contract manufacturer | ADS Dental Dam · Ehros Dental Dam · Sherbet Dental Dam | 1 | 2015 |
| Sotera Health LLC | United States | Contract manufacturer | SILI01/12 · SILI02/12 · SILI023/8 · SILI026/20 · +5 | — | — |
| Wuxi Lyusmile Imp and Exp Co.,ltd | China | Private-label distributor | dental rubber dam frame · PLASTIC RUBBER DAM FRAME · RUBBER DAM CLAMP · rubber dam kit · +6 | — | — |
| Dentimed Sao Joao LLC | United States | Repacker / relabeler | ANGELUS · Angelus | — | — |
| TitanLinks Logistics LLC | United States | Repacker / relabeler | Dental Instrument | — | — |
| Jmu Dental, Inc. | United States | Repacker / relabeler | Dental Dam · JMU Natural Latex Dental Rubber Dam | — | — |
| Patterson Companies, Inc. | United States | Foreign exporter | Patterson Rubber Dam · Patterson® Rubber Dam Forceps | — | — |
| Ortho Pro Dent LLC | United States | Repacker / relabeler | Devon- Gel · Devon-Paste | — | — |
| Soher Med Limited | Hong Kong SAR China | Foreign exporter | Clamp | — | — |
| STERIS Corporation | United States | Contract sterilizer | — | — | — |
| HSG-S Corp | United States | Manufacturer | EdgeDam | — | — |
| Aspen Surgical Products | United States | Contract manufacturer | Symmetry Surgical | — | — |
| Samtrade Supplies Inc. | Canada | Foreign exporter | Rubber Dam | — | — |
| Cislak Manufacturing, Inc. | United States | Contract manufacturer | Cislak · Zoll Dental | — | — |
| International Orthodontics Services. PC | United States | Repacker / relabeler | Liquid Dam | — | — |
| Premium Plus Dental | United States | Lister | CLAMP. RUBBER DAM · Premium Plus Rubber Dam Frame | — | — |
| Nordent MFG., Inc. | United States | Contract manufacturer | Brewer Rubber Dam Clamp Forcep · Brewer Rubber Dam Clamp Forceps | — | — |
| SPS/Crosstex International | United States | Manufacturer | Dental Dam, Latex, Powder Free/Low Protein · Dental dam, Non-Latex | — | — |
| PDT Inc. | United States | Contract manufacturer | PDT | — | — |
| TBS Dental | United States | Repacker / relabeler | TBS INOX · TBS INOX USA | — | — |
| Wise Linkers LLC | United States | Repacker / relabeler | Artman Instruments | — | — |
| Sklar Corporation | United States | Repacker / relabeler | Rubber Dam Clamp | — | — |
| Maxill Inc. | United States | Foreign exporter | Maxill | — | — |
| Beaming White LLC | United States | Manufacturer | Dental Gum Dam | — | — |
| Boen Healthcare Co Ltd | China | Foreign exporter | forceps; rubber dam clamp | — | — |
| Dental Brands for Less | Canada | Foreign exporter | COLTENE · CROSSTEX | — | — |
| WSD Labs Usa Inc. | United States | Repacker / relabeler | Dental Dam/Dental Gum Dam/ Gum Protector Gel/ Gingival Protection Gel | — | — |
| E/T Endodontic Technologies, Ltd. | Canada | Foreign exporter | ISOLATE PREMIUM DENTAL DAM | — | — |
| Sanicure BV | Netherlands | Foreign exporter | — | — | — |
| Zapalign LLC | United States | Repacker / relabeler | — | — | — |
| Novo Surgical Inc. | United States | Repacker / relabeler | — | — | — |
| Performance Health Supply | United States | Repacker / relabeler | Elasti-Dam · HYGENIC DENTAL DAM · NON-LATEX DENTAL DAM · Rubber Dam | — | — |
| Kash Sales Inc. | Canada | Foreign exporter | — | — | — |
| My Medical Store LLC | United States | Repacker / relabeler | MY MEDICAL | — | — |
| Amnotec International Medical GmbH | Germany | Repacker / relabeler | — | — | — |
| Mainline Medical Dental Supply | Canada | Foreign exporter | — | — | — |
| Maxmorespine | United States | Lister | — | — | — |
| Oketz Logistics LLC | United States | Repacker / relabeler | — | — | — |
| TG Worldwide Sdn. Bhd. | Malaysia | Foreign exporter | — | — | — |
| Timesco Healthcare Ltd | United Kingdom | Manufacturer | — | — | — |
| Vehu Medical Instrumente GmbH | Germany | Repacker / relabeler | — | — | — |
| Wexler Surgical Inc. | United States | Repacker / relabeler | — | — | — |
| Worldwide Supplies Limited | Hong Kong SAR China | Foreign exporter | — | — | — |
Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026
Where rubber dams 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 |
|---|---|---|---|---|
| Rubber Dam Clamp ForcepsEJG | 1 | 872.6300 | 77 | 1 |
| Rubber DamEIE | 1 | 872.6300 | 74 | 33 |
| Rubber Dam ClampEEF | 1 | 872.6300 | 74 | 3 |
| Rubber Dam FrameEJE | 1 | 872.6300 | 43 | 3 |
Recent clearances
| Decided | 510(k) | Device | Applicant | Device type |
|---|---|---|---|---|
| 3 May 2019 | K182118 | armor LC | Mavrik Dental Systems, Ltd. | EIE Rubber Dam |
| 18 Feb 2016 | K151945 | Triumph Resin Dam | Denali Corporation | EIE Rubber Dam |
| 21 Sep 2007 | K071615 | FIXAFLOSS | Sybron Dental Specialties | EEF Rubber Dam Clamp |
| 4 Mar 2005 | K050318 | BARI-KAD PACKING DEVICE | Bioenvelop Agro, Inc. | EIE Rubber Dam |
| 25 Jan 2005 | K043301 | GC TION GINGIVAL PROTECTOR | GC America Inc. | EIE Rubber Dam |
| 2 Apr 2004 | K040797 | BRITESMILE MASKING CREAM | Britesmile, Inc. | EIE Rubber Dam |
| 26 Sep 2002 | K022522 | PULPDENT PUTTY DAM | Pulpdent Corporation | EIE Rubber Dam |
| 19 Jul 2002 | K021524 | LIGHT CURE DENTAL DAM | Prime Dental Manufacturing, Inc. | EIE Rubber Dam |
| 20 Jun 2002 | K021613 | NIVEOUS LIQUID DAM | Shofu Inc | EIE Rubber Dam |
| 5 Sep 2001 | K010935 | BRITESMILE BARRIER MATERIAL | Britesmile, Inc. | EIE Rubber Dam |
| 11 Dec 1998 | K983227 | POWER BLOCK | Kreativ, Inc. | EIE Rubber Dam |
| 27 Feb 1998 | K972775 | FASTDAM | Interdent, Inc. | EIE Rubber Dam |
| 7 Aug 1996 | K961472 | DENTAL DAM SILICONE | Worldwide Dental, Inc. | EIE Rubber Dam |
| 26 Jan 1996 | K954990 | DENTAL DAM | The Hygenic Company, LLC | EIE Rubber Dam |
| 19 Oct 1995 | K952628 | ROYAL SHIELD NON-STERILE POWDER-FREE RUBBER DAMS | Elastomade Accessories Sdn Bhd | EIE Rubber Dam |
| 21 Sep 1994 | K942992 | ROYAL SHIELD RUBBER DAMS | Elastomade Accessories Sdn Bhd | EIE Rubber Dam |
| 22 Jul 1993 | K923157 | DENTAL RUBBER DAM | Aseptico, Inc. | EIE Rubber Dam |
| 28 Dec 1992 | K923163 | RUBBER DAM CLAMP | Aseptico, Inc. | EIE Rubber Dam |
| 17 Sep 1992 | K921771 | MINIDAM II | Delsan Dental Systems | EIE Rubber Dam |
| 14 Feb 1992 | K915207 | DISPOSABLE RADIOLUCENT RUBBER DAM CLAMP | Bay Technical Products, Inc. | EEF Rubber Dam Clamp |
| 25 Apr 1991 | K905470 | STANDARD RUBBER DAM WITH OR WITHOUT FRAMES | Elastomade Accessories Sdn Bhd | EIE Rubber Dam |
| 6 Jun 1990 | K901236 | RUBBER, DENTAL DAM (NON-STERILE) | Naturub Sdn. Bhd. | EIE Rubber Dam |
| 16 Apr 1990 | K900844 | WEDJETS | The Hygenic Company, LLC | EIE Rubber Dam |
| 21 Aug 1989 | K894120 | MADEGOM LTDA. DENTAL DAM | Madegom | EIE Rubber Dam |
| 16 May 1989 | K885231 | KITCHIN DENTAL ABCESS DRAIN | Kitchin, Inc. | EIE Rubber Dam |
| 29 Mar 1989 | K890667 | RUBBER DAM | Cost Rite Health Products, Inc. | EIE Rubber Dam |
| 3 Feb 1989 | K884828 | HANDIDAM | Aseptico, Inc. | EIE Rubber Dam |
| 18 Mar 1988 | K875255 | DREAM DAM | Dental Dam, Inc. | EIE Rubber Dam |
| 18 Nov 1986 | K864096 | DREAM DAM | Dental Dam, Inc. | EIE Rubber Dam |
| 27 Oct 1986 | K863816 | IVORY PREMIUM RUBBER DAM | Columbus Dental Mfg. Co. | EIE Rubber Dam |
| 18 Dec 1985 | K852630 | DEN-MAT PAINT-ON RUBBER DAM | Den-Mat Corp. | EIE Rubber Dam |
| 22 Apr 1985 | K851045 | DENT-DR. VACU-FRAME | Dent-Dr. | EIE Rubber Dam |
| 17 Aug 1984 | K842844 | DENTI-D RUBBER DAM | Fema Corp. | EIE Rubber Dam |
| 10 Jan 1984 | K833610 | DENTAL RUBBERDAM | Center For Marketing Services | EIE Rubber Dam |
| 10 Oct 1978 | K781520 | RUBBER DAM HOLDER | Young Innovations Inc | EJE Rubber Dam Frame |
| 12 May 1978 | K780745 | RUBBER DAM | Hygienic Dental Mfg., Co., The | EIE Rubber Dam |
| 12 May 1978 | K780744 | BRINKER TISSUE RETRACTORS | Hygienic Dental Mfg., Co., The | EEF Rubber Dam Clamp |
| 12 May 1978 | K780746 | HYGIENIC RUBBER DAM FRAME | Hygienic Dental Mfg., Co., The | EJE Rubber Dam Frame |
| 12 May 1978 | K780743 | CLAMP FORCEPS | Hygienic Dental Mfg., Co., The | EJG Rubber Dam Clamp Forceps |
| 28 Jan 1977 | K770117 | HYGIENIC 5 & 6 RUBBER DAM FRAME | Hygienic Dental Mfg., Co., The | EJE Rubber Dam Frame |