Miscellaneous devices · 21 CFR 872 Subpart G
Articulation Paper
FDA device type “Paper, Articulation”.
- Companies listing it
- 7039 makers
- Brands and models
- 104
- 510(k) clearances
- 100 in five years
- FDA name
- Paper, Articulation
510(k) clearances per year, 1976–2026
Companies that list EFH
70 companies currently list this device type with FDA.
| Company | Country | Role | Brands and models listed | Clearances | Latest |
|---|---|---|---|---|---|
| Dentsply Sirona, Inc. | United States | Maker | — | 148 | 2026 |
| Sybron Dental Specialties | United States | Maker | Flex Tabs · High Spot Indicating Paste · High Spot Indicating Spray | 203 | 2026 |
| Parkell, Inc | United States | Maker | — | 58 | 2025 |
| Keystone Industries | United States | Maker | Mizzy PIP Aerosol · Mizzy Pressure Indicating Paste (PIP) · Prehma Articulating Paper · Prehma Horseshoe Articulating Paper | 2 | 2025 |
| HDI Inc. | South Korea | Maker | Denu Shim Stock | 2 | 2022 |
| Good Doctors Co., Ltd. | South Korea | Maker | OA-DCG10 | 5 | 2023 |
| Angelus Industria DE Produtos Odontologicos S/A | Brazil | Maker | CONTACTO ARCH · CONTACTO FILM · CONTACTO ORTO · CONTACTO PAPER | 11 | 2021 |
| Whip Mix Corporation | United States | Maker | ARDENT DENTAL ARTICULATING PAPER · FILM | 8 | 2016 |
| DMETEC Co., LTD | South Korea | Maker | ACCURA | 5 | 2017 |
| Integra LifeSciences Corporation | United States | Maker | Articodent · Miltex | 2 | 2014 |
| Hager Worldwide, Inc. | United States | Maker | Madam Butterfly · Mylar Foil · Occlu-Plus · Shimstock · +1 | 2 | 2005 |
| George Taub Products & Fusion Co., Inc. | United States | Maker | BRIGHT SPOT I · BRIGHT SPOT II · BRIGHT SPOT III · BRIGHT SPOT IV · +3 | 2 | 1986 |
| Temrex Corp. | United States | Maker | ARTICULATING PAPER | 2 | 2012 |
| Directa AB | Sweden | Maker | TrollFoil | 1 | 2015 |
| COLTENE Holding AG | Switzerland | Maker | HANEL Articulating paper · HANEL Foil Dispenser · HANEL OccluFoil+ · HANEL Occlusion Foil · +1 | 1 | 2003 |
| Debo Medical Technology (Shijiazhuang) Co., Ltd. | China | Maker | articulating paper · PAPER, ARTICULATION | — | — |
| Pascal International | United States | Maker | HYDENT · HYDENT STICKS · OCCLUDE | — | — |
| Tangshan Zhengtong Exhibition Co., Ltd. | China | Maker | Articulating Paper | — | — |
| ZOGEAR Medical Co., Ltd. | China | Maker | PAPER, ARTICULATION | — | — |
| Hubei Guarddent Medical Technology Co.,Ltd | China | Maker | Articulating Paper | — | — |
| BH Medical Products Co., Ltd | China | Maker | Articulating paper | — | — |
| Towne Brothers (Pvt) Ltd | Pakistan | Maker | PAPER, ARTICULATION | — | — |
| TF New Material Sci and Tec Co.,ltd | China | Maker | Articulating Paper | — | — |
| Produits Dentaires SA | Switzerland | Maker | Articulating paper | — | — |
| Henan Baistra Medical Devices Limited | China | Maker | PAPER, ARTICULATION | — | — |
| Henan Lusterdent Medical Instrument Co.,Ltd | China | Maker | Articulating Paper | — | — |
| Shanghai smedent medical instrument co., ltd. | China | Maker | Dental Articulating Paper | — | — |
| Aadi Med Private Limited | India | Maker | MAARC Dental Articulating Paper | — | — |
| Svenska Dentorama AB | Sweden | Maker | Dentorama Articulating Paper, Curved · Dentorama Articulating Paper, Horse-shoe | — | — |
| Hefei Mlush Sanitary Products Co., Ltd | China | Maker | Articulating Paper | — | — |
| Wolf X-Ray Corp | United States | Maker | EXPOSURE ARTICULATING FILM · EXPOSURE DOUBLE ARTICULATING FILM | — | — |
| SKY DENT Corp for dental trading | United States | Maker | SKY DENT ARTICULATING PAPER - 1DERFUL ARTICULATING PAPER | — | — |
| Anhui JM Healthcare Products Co.,Ltd. | China | Maker | Articulating paper,dental bite paper | — | — |
| Dentaco GmbH & Co. KG | Germany | Maker | ACCUFILM IV | — | — |
| Harald Nordin S.A. | Switzerland | Maker | — | — | — |
| Tekscan Incorporated | United States | Maker | T-Scan · T-Scan Evolution · T-Scan Evolution Core · T-Scan III · +2 | — | — |
| Dr. Jean Bausch GmbH & Co. KG | Germany | Maker | ARTICULATING PAPERS · OccluSense | — | — |
| Renewmedical Co., Ltd. | South Korea | Maker | Renew SHIMSTOCK | — | — |
| W.R. Rayson Co Inc | United States | Maker | ARTICULATING PAPER | — | — |
| GC America Inc. | United States | Contract manufacturer | Articulating Paper | 137 | 2026 |
| Kulzer, LLC | United States | Contract manufacturer | Surgident Articulating Paper | 37 | 2026 |
| Den-Mat Holdings, LLC | United States | Manufacturer | Articulating Film | 8 | 2026 |
| Pac-Dent Inc. | United States | Contract manufacturer | — | 5 | 2022 |
| DSI Dental Solutions Ltd | Israel | Manufacturer | DSI OccuFoil | 2 | 2025 |
| Pulpdent Corporation | United States | Manufacturer | Bausch Arti-Fol · Bausch Arti-Fol Metallic · Bausch Arti-Spot Marking Liquid · Bausch Articulating Paper · +1 | 107 | 2021 |
| Dharma Research, Inc. | United States | Contract manufacturer | ADS Articulating Paper · Ehros Articulating Paper · Sherbet Articulating Paper | 1 | 2015 |
| One Dashcorp | United States | Repacker / relabeler | Valdent USA Articulating Paper, Blue/Red | — | — |
| Wuxi Lyusmile Imp and Exp Co.,ltd | China | Private-label distributor | articulating paper | — | — |
| Dentimed Sao Joao LLC | United States | Repacker / relabeler | ANGELUS | — | — |
| TitanLinks Logistics LLC | United States | Repacker / relabeler | PAPER, ARTICULATION | — | — |
| Jmu Dental, Inc. | United States | Repacker / relabeler | Articulating Papers | — | — |
| Patterson Companies, Inc. | United States | Foreign exporter | Patterson® Articulating Paper | — | — |
| Soher Med Limited | Hong Kong SAR China | Foreign exporter | Paper, Articulation | — | — |
| Aspen Surgical Products | United States | Contract manufacturer | Symmetry Surgical | — | — |
| Orthometric Ind. e Com. de Prod. Med. Odont. | Brazil | Manufacturer | ORTHOMETRIC ACETATE TRACING PAPER | — | — |
| Premium Plus Dental | United States | Lister | — | — | — |
| SPS/Crosstex International | United States | Manufacturer | Horse Shoe · Precisely True · Standard Articulating Paper | — | — |
| Yizur Ltd | Hong Kong SAR China | Foreign exporter | PAPER, ARTICULATION | — | — |
| CARGUS International Inc. | United States | Repacker / relabeler | — | — | — |
| READY SET IMPORT dba Mynt Professional | United States | Repacker / relabeler | RSI Articulating Paper | — | — |
| Maxill Inc. | United States | Foreign exporter | Maxill Articulating Film · Maxill Articulating Foil · Maxill Articulating Paper | — | — |
| Viarden Lab LLC | United States | Manufacturer for export | ARTICULATION PAPER VIARDEN LAB | — | — |
| Dental Brands for Less | Canada | Foreign exporter | Bausch | — | — |
| Prais Reliable Dental Supplies S.A | Seychelles | Foreign exporter | — | — | — |
| VastMEd LLC | United States | Repacker / relabeler | VASTMED PAPER, ARTICULATION | — | — |
| Common Sense Dental Products | United States | Repacker / relabeler | Prep Check | — | — |
| CBR Enterprise Limited | Hong Kong SAR China | Foreign exporter | — | — | — |
| Kash Sales Inc. | Canada | Foreign exporter | — | — | — |
| Mainline Medical Dental Supply | Canada | Foreign exporter | — | — | — |
| Oketz Logistics LLC | United States | Repacker / relabeler | — | — | — |
510(k) clearances
| Decided | 510(k) | Device | Applicant |
|---|---|---|---|
| 10 Feb 1997 | K965026 | PFINGST PRESSURE PASTE | Pfingst & Co., Inc. |
| 17 Jan 1992 | K912632 | OCCLUDE | Pascal Co., Inc. |
| 6 Jun 1991 | K911259 | HYDENT | Pascal Co., Inc. |
| 12 Feb 1987 | K864572 | FIXTECTOR | Prodent Intl., Inc. |
| 2 Feb 1987 | K870032 | REVISED T-SCAN SYSTEM | Sentek, Inc. |
| 21 Feb 1984 | K832647 | ARTICULATING PAPER | Ardent Intl., Inc. |
| 10 Feb 1984 | K833132 | MUCOSAL ADJUSTMENT PASTE LIQUID SPRAY | Myo-Tronics Research, Inc. |
| 17 Mar 1981 | K810498 | CENTRIC (BITE) REGISTRATION PASTE | Wallace A. Erickson & Co. |
| 20 Jun 1977 | K771011 | ARTICULATING PAPER | Parker Laboratories, Inc. |
| 21 Mar 1977 | K770492 | CRACK DETECTOR, DEN-MAT | Dey-Mat, Inc. |
Official records: FDA product classification for EFH · 21 CFR 872.6140.
Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026