Miscellaneous devices · 21 CFR 872 Subpart G
Rubber Dam
FDA device type “Dam, Rubber”.
- Companies listing it
- 10774 makers
- Brands and models
- 195
- 510(k) clearances
- 330 in five years
- FDA name
- Dam, Rubber
510(k) clearances per year, 1976–2026
Companies that list EIE
107 companies currently list this device type with FDA.
| 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 |
| Ultradent Products, Inc. | United States | Maker | OralSeal Kit · OralSeal Putty · OraSeal Caulking | 95 | 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 Dental Dam · HySolate Wedjet | 5 | 2026 |
| 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 |
| Den-Mat Holdings, LLC | United States | Maker | Edge Dam · Paint-On Dental Dam · True Dental Dam | 8 | 2026 |
| 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 · +2 | 45 | 2022 |
| DMG Chemisch-Pharmazeutische Fabrik GmbH | Germany | Maker | DMG MiniDam · DMG MiniDam 100x · DMG MiniDam 20x USA · DMG MiniDam Sample | 4 | 2022 |
| 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 | 107 | 2021 |
| Aseptico, Inc. | United States | Maker | I-70BM - HANDIDAM W/PLASTIC FRAME BLUE PKG OF 20 · I-70BM-100 - HANDIDAM ASEPTICO MED BLUE-100 PKG OF 100 · I-70K - CLAMP KIT HANDIDAM · I-70LF - HANDIDAM-LF LATEX FREE RUBBER DAM MAUVE PKG OF 20 · +1 | 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 |
| Prime Dental Manufacturing, Inc. | United States | Maker | Dental Dam · Light Cure Soft Dental Dam · Prime Blend Ultra · Prime-Paste | 9 | 2012 |
| 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 | 2 | 2001 |
| George Taub Products & Fusion Co., Inc. | United States | Maker | — | 2 | 1986 |
| Denali R & D Corporation | United States | Maker | Triumph | 2 | 2009 |
| B&L Biotech Co., Ltd. | South Korea | Maker | Rubber Dam | 1 | 2006 |
| Abracadabra Implants Ltd. | Israel | Maker | RRD - Round Rubber Dam | 1 | 2021 |
| 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 | DA614BP · DA614GM · DA618BP · DA618GM · +8 | — | — |
| Debo Medical Technology (Shijiazhuang) Co., Ltd. | China | Maker | Dental Dam · Dental Gum Dam · Gingival Protection Gel · Gum Protector Gel | — | — |
| 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 | — | — |
| Huanghua Promisee Dental Co., Ltd | China | Maker | Punch | — | — |
| Pomee Corporation | Pakistan | Maker | Rubber Dam · Rubber Dam Clamp | — | — |
| Accompany Surgical | Pakistan | Maker | Rubber Dam Clamp Forceps · Rubber Dam Clamp Frame · Rubber Dam Punch | — | — |
| Beyes Dental Inc | Canada | Maker | Dental Rubber Dams | — | — |
| Denta Craft Instruments | Pakistan | Maker | Rubber Dam Clamp Forceps; Rubber Dam Clamp Frame; Rubber Dam Punch | — | — |
| Jiangxi IVISMILE Technology Co.,Ltd | China | Maker | Dental Dam; Dental Gum Dam; Gum Protector Gel; Gingival Protection Gel | — | — |
| Medisporex Private Limited | Pakistan | Maker | RUBBER DAM CLAMP FORCEPS, RUBBER DAM FORCEPS PUNCH | — | — |
| Suzhou Ramo Medical Instrument Co., Ltd. | China | Maker | Rubber Dam | — | — |
| Hubei Guarddent Medical Technology Co.,Ltd | China | Maker | rubber dam | — | — |
| Guangzhou Xinuo Technology Co., Ltd | China | Maker | Dental Dam; Dental Gum Dam; Gum Protector Gel; Gingival Protection Gel; gingival barrier | — | — |
| 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 | EIE - DAM, RUBBER | — | — |
| Jiangxi Dentalbright Technology Co., Ltd | China | Maker | Dental Dam/Dental Gum Dam/ Gum Protector Gel/ Gingival Protection Gel | — | — |
| 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 | — | — |
| 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 | — | — |
| Svenska Dentorama AB | Sweden | Maker | Dentorama Non-Latex Dam · Dentorama Rubber Dam · VividDam Rubber Latex Dam | — | — |
| Zirc Dental Products Inc | United States | Maker | Airway Armor · Latex-Free Insti-Dam Relaxed Fit, Latex-Free Insti-Dam | — | — |
| LLRN Personal Care (Shenzhen) Co.,ltd | China | Maker | Dental Dam/Dental Gum Dam/ Gum Protector Gel/ Gingival Protection Gel | — | — |
| Viarden Lab LLC | United States | Maker | TOTAL DAM | — | — |
| Jiangxi Ushine Bright Medical Co., Ltd. | China | Maker | Gum Dam/ Gum Protetcor/Gingival Barrier | — | — |
| Changzhou IVORIE Shengmei Packaging Technology Co.Ltd | China | Maker | Dental Dam/Dental Gum Dam/ Gum Protector Gel/ Gingival Protection Gel | — | — |
| Elite Dental Lab | China | Maker | Rubber Dam | — | — |
| Fuzhou Delphin Bio-tech Co., Ltd. | China | Maker | Gum protector gel | — | — |
| Shandong Zhushi Pharmaceutical Group Co., Ltd | China | Maker | Dental Dam;Dental Gum Dam;Gum Protector Gel ;Gingival Protection Gel | — | — |
| Heyuan Hey White Technology Co., Ltd. | China | Maker | Gum health serum · Gum protector | — | — |
| PHS Do Brasil LTDA | Brazil | Maker | POTENZA BLOCCO | — | — |
| 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 | — | — |
| IPB Inc | United States | Maker | — | — | — |
| T33 Dental Inc. | United States | Maker | Rheyo Flex Barrier | — | — |
| Beyond International Inc. | United States | Maker | — | — | — |
| 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 | — | — |
| QUALITY LATEX PRODUCTS (PVT) Ltd. | United States | Maker | Latex dam | — | — |
| TG Medical Sdn Bhd | Malaysia | Maker | — | — | — |
| Zest Anchors, LLC | United States | Manufacturer | — | 26 | 2026 |
| Kulzer, LLC | United States | Contract manufacturer | IVORY RUBBER DAM · Ivory Rubber Dam Complete Kit · Ivory Rubber Dam Starter Kit · Venus White Max In-office Whitening Kit · +1 | 37 | 2026 |
| 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 |
| Directa AB | Sweden | Contract manufacturer | DRY-DAM · RAINBOW DENTAL RUBBER DAM & PUNCH | 1 | 2015 |
| 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 · RUBBER DAM | — | — |
| Dentimed Sao Joao LLC | United States | Repacker / relabeler | ANGELUS | — | — |
| Jmu Dental, Inc. | United States | Repacker / relabeler | JMU Natural Latex Dental Rubber Dam | — | — |
| Patterson Companies, Inc. | United States | Foreign exporter | Patterson Rubber Dam | — | — |
| Ortho Pro Dent LLC | United States | Repacker / relabeler | Devon- Gel · Devon-Paste | — | — |
| HSG-S Corp | United States | Manufacturer | EdgeDam | — | — |
| Aspen Surgical Products | United States | Contract manufacturer | Symmetry Surgical | — | — |
| Samtrade Supplies Inc. | Canada | Foreign exporter | Rubber Dam | — | — |
| International Orthodontics Services. PC | United States | Repacker / relabeler | Liquid Dam | — | — |
| SPS/Crosstex International | United States | Manufacturer | Dental Dam, Latex, Powder Free/Low Protein · Dental dam, Non-Latex | — | — |
| Maxill Inc. | United States | Foreign exporter | Maxill | — | — |
| Onvet Medical Canada Inc. | Canada | Manufacturer | Markson Flowdam | — | — |
| Beaming White LLC | United States | Manufacturer | Dental Gum Dam | — | — |
| Dentech Corp. | Japan | Contract manufacturer | Dentech Corporation | — | — |
| 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 | — | — |
| 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 | — | — | — |
510(k) clearances
| Decided | 510(k) | Device | Applicant |
|---|---|---|---|
| 3 May 2019 | K182118 | armor LC | Mavrik Dental Systems, Ltd. |
| 18 Feb 2016 | K151945 | Triumph Resin Dam | Denali Corporation |
| 4 Mar 2005 | K050318 | BARI-KAD PACKING DEVICE | Bioenvelop Agro, Inc. |
| 25 Jan 2005 | K043301 | GC TION GINGIVAL PROTECTOR | GC America Inc. |
| 2 Apr 2004 | K040797 | BRITESMILE MASKING CREAM | Britesmile, Inc. |
| 26 Sep 2002 | K022522 | PULPDENT PUTTY DAM | Pulpdent Corporation |
| 19 Jul 2002 | K021524 | LIGHT CURE DENTAL DAM | Prime Dental Manufacturing, Inc. |
| 20 Jun 2002 | K021613 | NIVEOUS LIQUID DAM | Shofu Inc |
| 5 Sep 2001 | K010935 | BRITESMILE BARRIER MATERIAL | Britesmile, Inc. |
| 11 Dec 1998 | K983227 | POWER BLOCK | Kreativ, Inc. |
| 27 Feb 1998 | K972775 | FASTDAM | Interdent, Inc. |
| 7 Aug 1996 | K961472 | DENTAL DAM SILICONE | Worldwide Dental, Inc. |
| 26 Jan 1996 | K954990 | DENTAL DAM | The Hygenic Company, LLC |
| 19 Oct 1995 | K952628 | ROYAL SHIELD NON-STERILE POWDER-FREE RUBBER DAMS | Elastomade Accessories Sdn Bhd |
| 21 Sep 1994 | K942992 | ROYAL SHIELD RUBBER DAMS | Elastomade Accessories Sdn Bhd |
| 22 Jul 1993 | K923157 | DENTAL RUBBER DAM | Aseptico, Inc. |
| 28 Dec 1992 | K923163 | RUBBER DAM CLAMP | Aseptico, Inc. |
| 17 Sep 1992 | K921771 | MINIDAM II | Delsan Dental Systems |
| 25 Apr 1991 | K905470 | STANDARD RUBBER DAM WITH OR WITHOUT FRAMES | Elastomade Accessories Sdn Bhd |
| 6 Jun 1990 | K901236 | RUBBER, DENTAL DAM (NON-STERILE) | Naturub Sdn. Bhd. |
| 16 Apr 1990 | K900844 | WEDJETS | The Hygenic Company, LLC |
| 21 Aug 1989 | K894120 | MADEGOM LTDA. DENTAL DAM | Madegom |
| 16 May 1989 | K885231 | KITCHIN DENTAL ABCESS DRAIN | Kitchin, Inc. |
| 29 Mar 1989 | K890667 | RUBBER DAM | Cost Rite Health Products, Inc. |
| 3 Feb 1989 | K884828 | HANDIDAM | Aseptico, Inc. |
| 18 Mar 1988 | K875255 | DREAM DAM | Dental Dam, Inc. |
| 18 Nov 1986 | K864096 | DREAM DAM | Dental Dam, Inc. |
| 27 Oct 1986 | K863816 | IVORY PREMIUM RUBBER DAM | Columbus Dental Mfg. Co. |
| 18 Dec 1985 | K852630 | DEN-MAT PAINT-ON RUBBER DAM | Den-Mat Corp. |
| 22 Apr 1985 | K851045 | DENT-DR. VACU-FRAME | Dent-Dr. |
| 17 Aug 1984 | K842844 | DENTI-D RUBBER DAM | Fema Corp. |
| 10 Jan 1984 | K833610 | DENTAL RUBBERDAM | Center For Marketing Services |
| 12 May 1978 | K780745 | RUBBER DAM | Hygienic Dental Mfg., Co., The |
Official records: FDA product classification for EIE · 21 CFR 872.6300.
Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026