Diagnostic devices · 21 CFR 872 Subpart B
X-Ray Film Holder
FDA device type “Holder, Film, X-Ray”.
- Companies listing it
- 12380 makers
- Brands and models
- 358
- 510(k) clearances
- 80 in five years
- FDA name
- Holder, Film, X-Ray
510(k) clearances per year, 1976–2026
Companies that list EGZ
123 companies currently list this device type with FDA.
| Company | Country | Role | Brands and models listed | Clearances | Latest |
|---|---|---|---|---|---|
| Dentsply Sirona, Inc. | United States | Maker | Adhesive Bite-Wing Tabs · Adhesive Comfort Tab for Film -Cover Cozee® · BAI Bite-Block film holders · BAI Instrument Kits · +29 | 148 | 2026 |
| Sybron Dental Specialties | United States | Maker | Digital Imaging & Accessories · Endo-Bite Senso · Hawe Imaging Plate Holder Test · Hawe Testset X-Ray · +3 | 203 | 2026 |
| Inter-Med, Inc. | United States | Maker | Vista Bite Wing Tabs | 7 | 2026 |
| Durr Dental SE | Germany | Maker | VistaPosition Anterior · VistaPosition Bitewing · VistaPosition Endo · VistaPosition Posterior | 6 | 2023 |
| Ttbio Corp. | Taiwan | Maker | — | 6 | 2023 |
| Premium Plus (Dongguan) Limited | China | Maker | Disposable peel-n-stick sensor holders · X-Ray Bite Cushions, Bite Wing Loops · X-Ray film holder, film clips | 2 | 2025 |
| Lakong Medical Devices Co., Ltd. | China | Maker | X-ray film mounting, holder, positioner | 2 | 2026 |
| Dental Imaging Technologies Corporation | United States | Maker | Imaging Sensor Holder | 2 | 2026 |
| Shenzhen Xpectvision Technology Co., Ltd. | China | Maker | Intraoral X-ray Sensor Holder, Model XVH001 | 2 | 2024 |
| DMG Chemisch-Pharmazeutische Fabrik GmbH | Germany | Maker | Icon X-ray holder Intro Kit · Icon X-ray holder Refill Size 1 · Icon X-ray holder Refill Size 2 · Icon X-ray holder Size 1 20+2 · +3 | 4 | 2022 |
| Shenzhen Rogin Medical Co., Ltd. | China | Maker | Dental X-Ray holder | 1 | 2025 |
| ProEdge Dental Products | United States | Maker | SoftX Foam Digital Sensor Loops | 1 | 2023 |
| Integra LifeSciences Corporation | United States | Maker | Integra · Miltex | 2 | 2014 |
| Hager Worldwide, Inc. | United States | Maker | Salibag · Soft Bitewing Flap | 2 | 2005 |
| Temrex Corp. | United States | Maker | BITE WING TABS | 2 | 2012 |
| Microcopy, Div. Neo-Flo, Inc. | United States | Maker | Flaps | 2 | 1989 |
| Directa AB | Sweden | Maker | CHEEK RETRACTOR · TrollBag · TrollByte · TrollByte Kimera | 1 | 2015 |
| Athlos Oy | Finland | Maker | Athlos-Air Holders · DC-Air Holders | 1 | 2021 |
| Debo Medical Technology (Shijiazhuang) Co., Ltd. | China | Maker | Complete Dental X-ray Film Positioning System · Dental X-ray Film Bracket · X-ray Film Holder | — | — |
| B. Ali Impex | Pakistan | Maker | BALI · DOCTOR NICE | — | — |
| Shenzhen Denco Medical Co Ltd | China | Maker | Dental X-Ray holder | — | — |
| Practicon, Inc. | United States | Maker | PlateMates PSP Protectors | — | — |
| Huanghua Promisee Dental Co., Ltd | China | Maker | X-ray film holder | — | — |
| Falcon Surgical Co. (Pvt.) Ltd. | Pakistan | Maker | X-Ray Holder | — | — |
| Shanghai Alwings Medical Instrument Co.,Ltd. | China | Maker | Barrier Envelope · Plastic Dispenser · Plastic Holder · X-ray Film Clip · +1 | — | — |
| Panorama International | Pakistan | Maker | Holder, film, x-ray | — | — |
| Shanghai Dochem Industries Co., Ltd. | China | Maker | X-ray film holder, film-holder | — | — |
| Accompany Surgical | Pakistan | Maker | NEELDLE HOLDERS | — | — |
| Shanghai Jolly Industrial Co., Ltd. | China | Maker | Bite wing tabs | — | — |
| Comfort Surgical Instruments | Pakistan | Maker | Holder film x-ray | — | — |
| Shanghai Lions Industrial Co., Ltd. | China | Maker | BITE WING TABS | — | — |
| Beyes Dental Inc | Canada | Maker | Beyes Universal Sensor Holder | — | — |
| Confident Instruments | Pakistan | Maker | Artman Instruments | — | — |
| Tangshan Zhengtong Exhibition Co., Ltd. | China | Maker | Barrier Envelopes with Extended Tap · Covers for Barrier Envelopes, Paper covers · Film Mounts, Barrier Envelope, · Film Positioning System Complete · +1 | — | — |
| Denta Craft Instruments | Pakistan | Maker | NEELDLE HOLDERS | — | — |
| ZOGEAR Medical Co., Ltd. | China | Maker | Holder, film, x-ray | — | — |
| Acme Enterprises | Pakistan | Maker | TBS Dental | — | — |
| Surgicrafts | Pakistan | Maker | EGZ / Holder, film, x-ray | — | — |
| Acheron Instruments (Pvt.) Ltd. | Pakistan | Maker | X-ray Holder | — | — |
| Hubei Guarddent Medical Technology Co.,Ltd | China | Maker | Dental Bib holders · Phosphor Plate | — | — |
| BH Medical Products Co., Ltd | China | Maker | bite-wing tabs | — | — |
| Cangzhou Lankang Medical Instruments Developing Co., Ltd. | China | Maker | Dental Forceps · Dental X-ray clip | — | — |
| Guangzhou Xinuo Technology Co., Ltd | China | Maker | Forceps | — | — |
| Jiangsu Yabaobao Medical Instrument Co.,Ltd. | China | Maker | Film positioning system complete | — | — |
| Maco Bag Corp. | United States | Maker | Air Techniques 73066/2 Size 6 · Air Techniques 73248-0 Size 0 · Air Techniques 73248-1 Size 1 · Air Techniques 73248-2 Size 2 · +30 | — | — |
| Shenzhen Senlede Technologies Co., Ltd | China | Maker | Forceps | — | — |
| READY SET IMPORT dba Mynt Professional | United States | Maker | RSI Bite-Wing Tabs | — | — |
| Daddy D Pro | Pakistan | Maker | X-RAY HOLDER, FILM HANGER | — | — |
| HuangHua DK Dental Co., LTD, | China | Maker | X-Ray Film Holder, X-Ray system, Ring; Arm, Holder | — | — |
| Onvet Medical Canada Inc. | Canada | Maker | Aimax®-F Flim Holder; Aimax® -S Sensor Holder | — | — |
| Maquira Industria de Produtos Odontologicos | Brazil | Maker | CONE POSITIONER AUTOCLAVABLE · CONE POSITIONER CHEMICAL STERILIZATION · CONE POSITIONER ENDO+ AUTOCLAVABLE · CONE POSITIONER ENDO+ CHEMICAL STERILIZATION · +1 | — | — |
| Zhejiang Yamei Medical Equipment Technology Co., Ltd. | China | Maker | X-Ray Holder | — | — |
| G.S.T. Corporation Limited | India | Maker | Gold Cross · GSTC · Heuer | — | — |
| Tianjin Water Source Tech Co., Ltd. | China | Maker | Holder, Film, X-ray films | — | — |
| Guangzhou Four E's Scientific Co., Ltd. | China | Maker | Aiming Ring · Film Holder · Indicator Arm · Radiography Holder · +2 | — | — |
| Plasdent Shanghai Co., Ltd. | China | Maker | Holder, Film, X-ray films | — | — |
| DuPhaMed B.V. | Netherlands | Maker | bite block hygiene sleeve/barrier, several sizes · digital sensor hygiene sleeve/barrier, several sizes · digital sensor positioners, intraoral, Bite wing/Posterior/Periapical/Endo, size 1 and 2 · Foam Bites for edentulous patient · +11 | — | — |
| Jinyuan medical equipment(tianjin)co.,ltd | China | Maker | N/A | — | — |
| Wolf X-Ray Corp | United States | Maker | All-Bite, Digi Loops · Bite Block Baggies · DispozaSleeves · Endodontic Positioner · +8 | — | — |
| Shengiho Enterprise Co., Ltd. | Taiwan | Maker | FILM HOLDERS, ALIGNING SYSTEM, SNAP FILM HOLDER, SENSOR HOLDER | — | — |
| ClikTech, LLC | United States | Maker | ClikBite · ClikGuide · ClikRay · ClikStik · +8 | — | — |
| Omnia SRL | United States | Maker | LIGHT BARRIER · OMNITEX C · OMNITEX U · RAY BARRIER · +1 | — | — |
| Dhef Inc. | Taiwan | Maker | — | — | — |
| Dongguan Yilong Medical Supplies Co., Ltd. | China | Maker | XRAY Film Holer/ DIGITAL SENSOR HOLDER | — | — |
| Weihai Xingtai Packaging Products Co., Ltd. | China | Maker | Barrier Film | — | — |
| Tornado Plastics | Canada | Maker | DIGITAL SENSOR SHEATH · FLEX-BITE TAB · INTRA ORAL CAMERA SHEATHS · PHOSPHOR PLATE PROTECTOR | — | — |
| BiometerPlus USA, Inc. | United States | Maker | BIO Dental Radiographic Film | — | — |
| Fredricks/Plasteel Corp. | United States | Maker | EZ-PROP DISPOSABLE MOUTH PROP · STABE X-RAY FILM HOLDER · XCP X-RAY FILM HOLDER | — | — |
| BGSS Company Asia Limited | China | Maker | TRAY COVER | — | — |
| Hangzhou Fushan Medical Appliance Co., Ltd. | China | Maker | Bitewing Tabs · Digital Sensor Sleeves | — | — |
| Steri-Shield Incorporated | United States | Maker | X-ray Film Holder | — | — |
| Tianchang Jiarui Packaging Material Co., Ltd. | China | Maker | barrier film | — | — |
| 美舒博股份有限公司Medsorb Dominicana, S.A. | Dominican Republic | Maker | — | — | — |
| Carwild Corporation | United States | Maker | — | — | — |
| Coomex Sources Co. Ltd. | China | Maker | X-Ray Film Holder | — | — |
| Techno-Aide | United States | Maker | Techno-Aide: Mobile CR/DR panel holder, Lateral imaging receptor holder | — | — |
| Top Operator Products | New Zealand | Maker | Oneshot | — | — |
| TIDI Products LLC | United States | Maker | — | — | — |
| Trelleborg Sealing Solutions Plymouth LLC | United States | Maker | — | — | — |
| Wenzhou Wapro Technology CO LTD | China | Maker | — | — | — |
| Young Innovations Inc | United States | Contract manufacturer | barrier sleeves and films | 23 | 2025 |
| Pac-Dent Inc. | United States | Contract manufacturer | 131116 EzAim ComforTab Adhesive Sensor Holder Anterior Blue, 50/pk · 131116 EzAim Individually Cut Adhesive Sensor Holder Anterior Blue, 50/pk · 131117 EzAim ComforTab Adhesive Sensor Holder Anterior White, 50/pk · 131117 EzAim Individually Cut Adhesive Sensor Holder Anterior White, 50/pk · +6 | 5 | 2022 |
| Carestream Dental LLC | United States | Foreign exporter | CG913 · CGH99 · CGL12 · CGP09 · +64 | 11 | 2020 |
| Dentamerica | United States | Repacker / relabeler | — | 4 | 2010 |
| Tpc Advanced Technology, Inc. | United States | Repacker / relabeler | TPC Disposable Plastic Xray Film Holder | 3 | 2007 |
| Rmo, Inc. | United States | Manufacturer | FITZGERALD X-RAY HOLDING UNIT | 1 | 1990 |
| Apixia, Inc. | United States | Repacker / relabeler | — | 1 | 2012 |
| One Dashcorp | United States | Repacker / relabeler | Valdent USA 1-5/8" x 8" Disposable Digital X-Ray Sensor Sleeves · Valdent USA 2-1/2" x 10" Disposable Digital X-Ray Sensor Sleeves · Valdent USA X-Ray Anterior Positioning Arm, Blue Prongs, Single Arm · Valdent USA X-Ray Bite Wing Positioning Arm, Red Prongs, Single Arm · +2 | — | — |
| Wuxi Lyusmile Imp and Exp Co.,ltd | China | Private-label distributor | digital sensor holder · Digital sensor Positioner · Film Positioning System Complete · Imaging Plate Barrier Envelopers · +8 | — | — |
| Dentimed Sao Joao LLC | United States | Repacker / relabeler | angelus Holder, Film, X-Ray · dentq Holder, Film, X-Ray · torino Holder, Film, X-Ray | — | — |
| TitanLinks Logistics LLC | United States | Repacker / relabeler | Positioning Arm | — | — |
| Jmu Dental, Inc. | United States | Repacker / relabeler | JMU Dental X-Ray Positioning Aiming Ring | — | — |
| Patterson Companies, Inc. | United States | Foreign exporter | Patterson® Digital X-ray Sensor Sheaths | — | — |
| Soher Med Limited | Hong Kong SAR China | Foreign exporter | Film Holder | — | — |
| Aspen Surgical Products | United States | Contract manufacturer | Symmetry Surgical | — | — |
| Premium Plus Dental | United States | Lister | Premium Plus X-Ray Film Holder | — | — |
| SPS/Crosstex International | United States | Manufacturer | Bitewing Ease · Edge Ease · It's-A-Wrap · Sensor Slippers | — | — |
| Yizur Ltd | Hong Kong SAR China | Foreign exporter | Positioning Arm | — | — |
| TBS Dental | United States | Repacker / relabeler | TBS INOX USA | — | — |
| CARGUS International Inc. | United States | Repacker / relabeler | MARK3® Bib Holder Autoclavable Silicon · MARK3® Bite Wing Tabs | — | — |
| LLD Care d.o.o. | Croatia | Foreign exporter | X-Ray Holder | — | — |
| battech | United States | Repacker / relabeler | dental bibs holder | — | — |
| Shanghai MU PROMOTIONS Co., Ltd. | China | Foreign exporter | Film Positioning System Complete | — | — |
| Shanghai smedent medical instrument co., ltd. | China | Foreign exporter | Plastic Film Holder, Bite Block, Barrier Envelope, Sensor Holder, Film Mount | — | — |
| Plasdent Corporation | United States | Repacker / relabeler | Plastic Film Holder,Bite Block,Film carrier,Barrier envelopes, Aligning system,Snap film holder,Sensor holder,Film Mount | — | — |
| Dongguan Wanjin Industrial Co., Ltd | China | Manufacturer | X Ray Holder | — | — |
| Dental Brands for Less | Canada | Foreign exporter | DENTSPLY | — | — |
| Dukal Corporation | United States | Specification developer | Private label-Self-Adhesive Bite-Wing Tabs | — | — |
| HI Medical Co., Ltd. | South Korea | Foreign exporter | Dentsply | — | — |
| Sanicure BV | Netherlands | Foreign exporter | — | — | — |
| Zapalign LLC | United States | Repacker / relabeler | — | — | — |
| Peter Brasseler Holdings, LLC | United States | Contract manufacturer | — | — | — |
| Zapalign Inc. | South Korea | Foreign exporter | — | — | — |
| Prais Reliable Dental Supplies S.A | Seychelles | Foreign exporter | — | — | — |
| Kash Sales Inc. | Canada | Foreign exporter | — | — | — |
| 3D Dental Designs and Development LLC | United States | Contract manufacturer | — | — | — |
| MN Health Inc, | United States | Repacker / relabeler | — | — | — |
| Sanya Mercadent Packaging Supplies Ltd. Co. | China | Foreign exporter | Holder,film, x-ray | — | — |
| Siemens Healthineers AG | Germany | Foreign exporter | Kenex Mobile Cassett Holder | — | — |
| Mainline Medical Dental Supply | Canada | Foreign exporter | — | — | — |
| MHM Grupo Diamante, S.A. de C.V. | Mexico | Foreign exporter | — | — | — |
| Oketz Logistics LLC | United States | Repacker / relabeler | — | — | — |
| Zircon Plus Limited | Israel | Foreign exporter | — | — | — |
510(k) clearances
| Decided | 510(k) | Device | Applicant |
|---|---|---|---|
| 6 Sep 1991 | K913168 | SALIBAG | Nix Co. , Ltd. |
| 6 Sep 1991 | K913160 | ID-TAB | Nix Co. , Ltd. |
| 12 Jun 1989 | K890355 | DENTAL X-RAY BITE BLOCK | Bite-A-Block |
| 21 Jan 1986 | K853451 | TROLL-BITE | Trollplast, Inc. |
| 5 Sep 1985 | K852170 | EZX YELLOW, BLUE OR ORANGE | Strong Marketing |
| 13 Aug 1985 | K853005 | S.S. WHITE DENTAL X-RAY FILM HOLDER & ALIGNING ARM | The S. S. White Co. |
| 29 Jan 1982 | K813378 | UNI-BITE DENTAL X-RAY FILM HOLDER | Rinn Corp. |
| 20 May 1980 | K801079 | KWIX-BITE X-RAY FILM HOLDER | Henry Schein, Inc. |
Official records: FDA product classification for EGZ · 21 CFR 872.1905.
Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026