Miscellaneous devices · 21 CFR 872 Subpart G
Rubber Dam Frame
FDA device type “Frame, Rubber Dam”.
- Companies listing it
- 5743 makers
- Brands and models
- 60
- 510(k) clearances
- 30 in five years
- FDA name
- Frame, Rubber Dam
510(k) clearances per year, 1976–2026
Companies that list EJE
57 companies currently list this device type with FDA.
| Company | Country | Role | Brands and models listed | Clearances | Latest |
|---|---|---|---|---|---|
| Kulzer, LLC | United States | Maker | Ivory · Ivory Rubber Dam Frame | 37 | 2026 |
| Dent4You AG | Switzerland | Maker | Dental Dam Frame | 5 | 2026 |
| Young Innovations Inc | United States | Maker | RUBBER DAM HOLDER | 23 | 2025 |
| Dentalez, Inc. | United States | Maker | Visi-Frame | 9 | 2026 |
| Premium Plus (Dongguan) Limited | China | Maker | Rubber dam frame | 2 | 2025 |
| Coltene/Whaledent AG | Switzerland | Maker | Dental Dam Frame | 45 | 2022 |
| Pulpdent Corporation | United States | Maker | PCA "DAM" FRAME | 107 | 2021 |
| Angelus Industria DE Produtos Odontologicos S/A | Brazil | Maker | OSTBY FRAME · RUBBER DAM FRAME | 11 | 2021 |
| 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 | 2 | 2014 |
| Manufacturera Dental Continental | Mexico | Maker | MDC NIC TONE RUBBER DAM | 2 | 2001 |
| Directa AB | Sweden | Maker | RAINBOW RUBBER DAM FRAME | 1 | 2015 |
| Osung Mnd Co Ltd | South Korea | Maker | RDFR1 · RDFR2 | — | — |
| TOR VM Ltd. | Russia | Maker | Cat.#3.401A Rubber dam frame · Cat.#3.401B Rubber dam frame · Cat.#3.402B Rubber dam frame · Cat.#3.403B Rubber dam frame | — | — |
| Zain's Medical Image | Pakistan | Maker | Rubber Dam Frame 4" · Rubber Dam Frame 5" · Rubber Dam Frame 6" | — | — |
| Densol International (Private) Limited | Pakistan | Maker | Rubber Dam Frame Large 12*12cm · Rubber Dam Frame Medium 9*10cm · Rubber Dam Frame Small 9*9cm | — | — |
| Debo Medical Technology (Shijiazhuang) Co., Ltd. | China | Maker | FRAME,RUBBER DAM | — | — |
| Dental Studio | South Korea | Maker | RUBBER DAM FRAME | — | — |
| Huanghua Promisee Dental Co., Ltd | China | Maker | Frame | — | — |
| Falcon Surgical Co. (Pvt.) Ltd. | Pakistan | Maker | Rubber Dam Frame | — | — |
| Endo Tech Instruments | Pakistan | Maker | Rubber Dam Frame Adult | — | — |
| Panorama International | Pakistan | Maker | FRAME, RUBBER DAM | — | — |
| Lacigrus International | Pakistan | Maker | FRAME, RUBBER DAM | — | — |
| Comfort Surgical Instruments | Pakistan | Maker | Rubber Dam frame | — | — |
| Aesculap AG | Germany | Maker | Aesculap | — | — |
| Confident Instruments | Pakistan | Maker | Artman Instruments | — | — |
| ZOGEAR Medical Co., Ltd. | China | Maker | FRAME, RUBBER DAM | — | — |
| Medisporex Private Limited | Pakistan | Maker | MEDIS | — | — |
| Acme Enterprises | Pakistan | Maker | TBS Dental | — | — |
| Towne Brothers (Pvt) Ltd | Pakistan | Maker | EJE - FRAME, RUBBER DAM | — | — |
| Y. Z. Corporation | Pakistan | Maker | YZ Rubberdam Frame | — | — |
| Svenska Dentorama AB | Sweden | Maker | DENTORAMA RUBBER DAM FRAME | — | — |
| Dentech Corp. | Japan | Maker | FRAME, RUBBER DAM | — | — |
| Hager & Werken | Germany | Maker | Rubber Dam | — | — |
| Sabokay Industries | Pakistan | Maker | FRAME, RUBBER DAM | — | — |
| Elite Dental Lab | China | Maker | Rubber Dam Frame | — | — |
| Sanctuary Health Sdn Bhd | Malaysia | Maker | — | — | — |
| 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 | — | — | — |
| Nextcon International | Pakistan | Maker | — | — | — |
| Tekno-Medical Optik-Chirurgie GmbH | Germany | Maker | — | — | — |
| Pac-Dent Inc. | United States | Contract manufacturer | — | 5 | 2022 |
| Aseptico, Inc. | United States | Contract manufacturer | I-16 - RUBBER DAM FRAME ADULT · I-17 - RUBBER DAM FRAME CHILD | 17 | 2015 |
| Hager Worldwide, Inc. | United States | Manufacturer | Plast Frame | 2 | 2005 |
| Wuxi Lyusmile Imp and Exp Co.,ltd | China | Private-label distributor | rubber dam frame | — | — |
| Dentimed Sao Joao LLC | United States | Repacker / relabeler | Angelus | — | — |
| STERIS Corporation | United States | Contract sterilizer | — | — | — |
| Aspen Surgical Products | United States | Contract manufacturer | Symmetry Surgical | — | — |
| Premium Plus Dental | United States | Lister | Premium Plus Rubber Dam Frame | — | — |
| PDT Inc. | United States | Contract manufacturer | PDT | — | — |
| TBS Dental | United States | Repacker / relabeler | TBS INOX USA | — | — |
| Wise Linkers LLC | United States | Repacker / relabeler | Artman Instruments | — | — |
| Amnotec International Medical GmbH | Germany | Repacker / relabeler | — | — | — |
| Mainline Medical Dental Supply | Canada | Foreign exporter | — | — | — |
| Oketz Logistics LLC | United States | Repacker / relabeler | — | — | — |
510(k) clearances
| Decided | 510(k) | Device | Applicant |
|---|---|---|---|
| 10 Oct 1978 | K781520 | RUBBER DAM HOLDER | Young Innovations Inc |
| 12 May 1978 | K780746 | HYGIENIC RUBBER DAM FRAME | Hygienic Dental Mfg., Co., The |
| 28 Jan 1977 | K770117 | HYGIENIC 5 & 6 RUBBER DAM FRAME | Hygienic Dental Mfg., Co., The |
Official records: FDA product classification for EJE · 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