Surgical devices · 21 CFR 872 Subpart E
Dental Plastic Filling Instrument
FDA device type “Instrument, Filling, Plastic, Dental”.
- Companies listing it
- 178137 makers
- Brands and models
- 537
- 510(k) clearances
- 50 in five years
- FDA name
- Instrument, Filling, Plastic, Dental
510(k) clearances per year, 1976–2026
Companies that list EIY
178 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 |
| Megagen Implant Co., Ltd. | South Korea | Maker | EZ Seal · EZ Seal Kit | 30 | 2026 |
| Sybron Dental Specialties | United States | Maker | Comporoller | 203 | 2026 |
| Ultradent Products, Inc. | United States | Maker | Black Micro FX Tips · SoftEZ Tips | 95 | 2026 |
| Foshan COXO Medical Instrument Co., Ltd. | China | Maker | Endodontic Obturation Systems; C-FILL; C-FILL MINI | 6 | 2025 |
| Premier Dental Products Company | United States | Maker | PREMIER PLASTIC FILLIN | 28 | 2026 |
| Young Innovations Inc | United States | Maker | AEI Composite Instruments | 23 | 2025 |
| Centrix, Inc. | United States | Maker | AccuDose Tubes, NeedleTubes & Tips | 44 | 2025 |
| Essential Dental Systems, Inc. | United States | Maker | EDS Mixing Tips, OVD Caps | 15 | 2023 |
| Garrison Dental Solutions LLC | United States | Maker | Composi-Tight® · PerForm | 3 | 2024 |
| ChangZhou BoMedent Medical Technology Co., Ltd | China | Maker | Endodontic Obturation Devices | 2 | 2022 |
| Shenzhen Rogin Medical Co., Ltd. | China | Maker | Gutta-Percha Obturation System (ELITE FILL-E); Microscope Paste Carriers · Microscope paste carriers additional parts · Microscope paste carriers super floss · Paste Carriers | 1 | 2025 |
| Odne AG | Switzerland | Maker | OdneFill Tip | 1 | 2024 |
| Sterngold | United States | Maker | ERA Pickup Mixing Tips | 24 | 2017 |
| Medicon EG | Germany | Maker | — | 9 | 2005 |
| Hu-Friedy Mfg Co., LLC | United States | Maker | Hu-Friedy Mfg Co.,LLC | 8 | 2012 |
| Neodental Chemical Products Co., Ltd. | Japan | Maker | Neo Flexpoint | 5 | 2011 |
| Storz AM Mark GmbH | Germany | Maker | Amalgam applicator · Burnisher · Composite instrument · Filling instrument · +3 | 2 | 2008 |
| Gebr. Brasseler GmbH & Co. KG | Germany | Maker | KOMET VARIOUS TYPES OF DENTAL HAND INSTRUMENTS | 1 | 2007 |
| BioMTA | South Korea | Maker | OrthoMTA Needle Tips | 1 | 2014 |
| Osung Mnd Co Ltd | South Korea | Maker | CSAT6 · CSCOM1 · CSCOM11 · CSCOM13 · +51 | — | — |
| ErgoDenta ApS | Denmark | Maker | Amalgam Condenser, 1mm-1.5mm · Amalgam Condenser, 2mm-2.5mm · Base Carrier - Condenser Malleable Tip · Base Carrier - Condenser Rigid · +74 | — | — |
| Zain's Medical Image | Pakistan | Maker | Composite Instrument · Composite Placement Instrument # F1 · Composite Placement Instrument # F2 · Composite Placement Instrument # F3 · +17 | — | — |
| Densol International (Private) Limited | Pakistan | Maker | Dental Ball Burnisher 0.8/1mm Slim Handle · Dental Ball Burnisher 1.2/1.6mm Slim Handle · Dental Ball Burnisher 1.2/1.6mm TIT Black FAT Handle · Dental Ball Burnisher 1.6/2.5mm Hopson TIT Black FAT Handle · +37 | — | — |
| Metro Medical | Pakistan | Maker | Filling Instruments, Ash, No. 1 · Filling Instruments, Ash, No. 2 · Filling Instruments, Ash, No. 3 · Filling Instruments, Ash, No. 4 · +89 | — | — |
| B. Ali Impex | Pakistan | Maker | BALI · DOCTOR NICE | — | — |
| Prodont-Holliger | France | Maker | MODELLING SPATULA CPR01 reference 194.12SI-modeling instr. bliss n1 · MODELLING SPATULA CPR02 reference 194.13SI-modeling instr. bliss n2 · MODELLING SPATULA CPR05 rference 194.16SI-modeling instr. bliss n5 · MODELLING SPATULA OP55 reference 1925SI-modelling instr. op55 bliss · +1 | — | — |
| Shenzhen Denco Medical Co Ltd | China | Maker | Gutta-Percha Obturation System; Microscope Paste Carriers · Microscope paste carriers additional parts, · Microscope paste carriers super floss, · Paste Carriers | — | — |
| TDV Dental Ltda | Brazil | Maker | Contact + Gold · FOTOPLUS · SeptoContact · SeptoCure | — | — |
| Huanghua Promisee Dental Co., Ltd | China | Maker | Adhesive tip applicator · Adhesive Tip Applicators · Matrix Bands Kit · One piece of medical forceps · +13 | — | — |
| Technimen Skillers | Pakistan | Maker | Landmore filling, woodson plastic filling, gregg plastic filling, | — | — |
| Cislak Manufacturing, Inc. | United States | Maker | Cislak · Zoll Dental | — | — |
| Falcon Surgical Co. (Pvt.) Ltd. | Pakistan | Maker | INSTRUMENT, FILLING, PLASTIC, DENTAL | — | — |
| Pomee Corporation | Pakistan | Maker | Plastic Filling Instruments | — | — |
| Endo Tech Instruments | Pakistan | Maker | Filling instruments set of 6pcs · Plastic Filling Instruments | — | — |
| FKG Dentaire Sarl | Switzerland | Maker | — | — | — |
| Nordent MFG., Inc. | United States | Maker | NORDENT PLASTIC FILLING INSTRUMENTS | — | — |
| Panorama International | Pakistan | Maker | INSTRUMENT, FILLING, PLASTIC, DENTAL | — | — |
| Shanghai Dochem Industries Co., Ltd. | China | Maker | baby tooth box · barrier film · chair cover · Denture Box · +7 | — | — |
| Accompany Surgical | Pakistan | Maker | P.F.I. | — | — |
| Shanghai Jolly Industrial Co., Ltd. | China | Maker | Denture box · Retainer box | — | — |
| Lacigrus International | Pakistan | Maker | INSTRUMENT, FILLING, PLASTIC, DENTAL | — | — |
| Comfort Surgical Instruments | Pakistan | Maker | filling instrument | — | — |
| Aesculap AG | Germany | Maker | Aesculap | — | — |
| PDT Inc. | United States | Maker | PDT, Inc. | — | — |
| Shanghai Lions Industrial Co., Ltd. | China | Maker | Denture box · retainer box | — | — |
| Adolf Schweick Hardt GmbH & Co | Germany | Maker | — | — | — |
| Confident Instruments | Pakistan | Maker | Artman Instruments | — | — |
| Denta Craft Instruments | Pakistan | Maker | P.F.I. | — | — |
| ZOGEAR Medical Co., Ltd. | China | Maker | INSTRUMENT, FILLING, PLASTIC, DENTAL | — | — |
| Hilbro Instruments (Pvt) Ltd | Pakistan | Maker | HILBRO INSTRUMENTS DENTAL · INSTRUMENT, FILLING, PLASTIC, DENTAL | — | — |
| Medisporex Private Limited | Pakistan | Maker | MEDIS | — | — |
| Dentag SRL | Italy | Maker | DENTAG | — | — |
| Garish Apparels | Pakistan | Maker | Tamzon Instruments Inc. | — | — |
| Acme Enterprises | Pakistan | Maker | TBS Dental | — | — |
| Surgicrafts | Pakistan | Maker | EIY / INSTRUMENT, FILLING, PLASTIC, DENTAL | — | — |
| Anqing Clean Dental Instrument Technology Co Ltd | China | Maker | dental mixing well/ dappening dish/bowl · disposable container/bag | — | — |
| Goldman Products, Inc. | United States | Maker | Goldman · Micro-Dent | — | — |
| Silver Plus Corp. | Pakistan | Maker | INSTRUMENT, FILLING, PLASTIC, DENTAL | — | — |
| Shanghai Medical Instruments (Group) Ltd. Corp. | China | Maker | — | — | — |
| Surgiscape | Pakistan | Maker | INSTRUMENT, FILLING, PLASTIC, DENTAL | — | — |
| Maryam Trading | Pakistan | Maker | INSTRUMENT, FILLING, PLASTIC, DENTAL | — | — |
| Bioclear Matrix Systems, LLC | United States | Maker | Bioclear Rubber Dam Stamp · Black Triangle Gauge · Evolve Matrix Height Indicator | — | — |
| Choose Surgical Instruments | Pakistan | Maker | INSTRUMENT, FILLING, PLASTIC, DENTAL | — | — |
| Lohar Medical Company | Pakistan | Maker | EIY / INSTRUMENT, FILLING, PLASTIC, DENTAL | — | — |
| READY SET IMPORT dba Mynt Professional | United States | Maker | Plastic Filling | — | — |
| TF New Material Sci and Tec Co.,ltd | China | Maker | Matrix Band | — | — |
| Nadir & Co. | Pakistan | Maker | Composite Instruments | — | — |
| Y. Z. Corporation | Pakistan | Maker | YZ Dental Filling Instruments | — | — |
| Daddy D Pro | Pakistan | Maker | Filling Instruments Plastic Dental | — | — |
| Hefei Xingcheng Sanitary Products CO.,LTD | China | Maker | Dental Kit, Retainer Box | — | — |
| Mount Blonck Trading | Pakistan | Maker | INSTRUMENT, FILLING, PLASTIC, DENTAL | — | — |
| HuangHua DK Dental Co., LTD, | China | Maker | Dental sectional contoured matrices; Dental sectional contoured matrices kit | — | — |
| Nopa Instruments Medizintechnik GmbH | Germany | Maker | PLASTIC FILLING INSTRUMENT | — | — |
| Onvet Medical Canada Inc. | Canada | Maker | Artica Si, SureTact | — | — |
| Dimeda Instrumente GmbH | Germany | Maker | DIMEDA | — | — |
| B. Braun Medical Industries Sdn. Bhd | Malaysia | Maker | Aesculap | — | — |
| Henan Baistra Medical Devices Limited | China | Maker | INSTRUMENT, FILLING, PLASTIC, DENTAL | — | — |
| HILBRO International (Pvt) Ltd. | Pakistan | Maker | INSTRUMENT, FILLING, PLASTIC, DENTAL | — | — |
| Meed Skills Surgical | Pakistan | Maker | Meed Skills Surgical | — | — |
| Hefei Mlush Sanitary Products Co., Ltd | China | Maker | Matrix Band | — | — |
| Spartech Instruments & Co. | Pakistan | Maker | INSTRUMENT, FILLING, PLASTIC, DENTAL | — | — |
| Hager & Werken | Germany | Maker | MIRA COMPO , COMPO BRUSH | — | — |
| MCTBIO Co., Ltd | South Korea | Maker | INSTRUMENT/ DENTAL | — | — |
| Melpex Beauty Instruments | Pakistan | Maker | INSTRUMENT, FILLING, PLASTIC, DENTAL | — | — |
| Shandong Hengfeng Kerui Medical Equipment Co., Ltd | China | Maker | Hand Dental Pluggers | — | — |
| Armatech International | Pakistan | Maker | INSTRUMENT, FILLING, PLASTIC, DENTAL · ZYREV | — | — |
| Central Surgical Co. Pvt. Ltd. | Pakistan | Maker | INSTRUMENT, FILLING, PLASTIC, DENTAL, FILLING INSTRUMENTS OF ALL TYPES | — | — |
| Sabokay Industries | Pakistan | Maker | Instrument, Filling, Plastic, Dental | — | — |
| Darleys Surgical Co. | Pakistan | Maker | INSTRUMENT, FILLING, PLASTIC, DENTAL | — | — |
| Elite Dental Lab | China | Maker | Composite Filling Instrument · Dental Composite Sculpting Instrument | — | — |
| Hazel Enterprises | Pakistan | Maker | INSTRUMENT, FILLING, PLASTIC, DENTAL | — | — |
| Surgikare | Pakistan | Maker | INSTRUMENT, FILLING, PLASTIC, DENTAL | — | — |
| T.A. Walthem & Company | Pakistan | Maker | INSTRUMENT, FILLING, PLASTIC, DENTAL | — | — |
| Washington Surgical International | Pakistan | Maker | INSTRUMENT, FILLING, PLASTIC, DENTAL | — | — |
| Zhongshan Xinhe Co.,Ltd | China | Maker | Instrument, Filling, Plastic, Dental | — | — |
| Gesco Healthcare Private Limited | India | Maker | GESCO | — | — |
| Infirmary Medical Supplies | Pakistan | Maker | INSTRUMENT, FILLING, PLASTIC, DENTAL | — | — |
| Madina Surgical Works | Pakistan | Maker | INSTRUMENT, FILLING, PLASTIC, DENTAL | — | — |
| Alvi Expo | Pakistan | Maker | INSTRUMENT, FILLING, PLASTIC, DENTAL | — | — |
| Hexamed Pvt Ltd | Pakistan | Maker | Dental Plastic Filling Instruments | — | — |
| Emerald Instruments | Pakistan | Maker | INSTRUMENT, FILLING, PLASTIC, DENTAL | — | — |
| Karl Hammacher GmbH | Germany | Maker | Karl Hammacher GmbH | — | — |
| Win Wings Corp. | Pakistan | Maker | INSTRUMENT, FILLING, PLASTIC, DENTAL | — | — |
| Zepf Medical Instrum | Germany | Maker | — | — | — |
| Chengdu Sani Medical Equipment CO.,LTD. | China | Maker | Composite instruments · Obturation System - Easy Fill; Obturation Downpack Device - Easy Pack; Condenser-N35/S70, N40/S80,N50/S100, N60/S120 | — | — |
| Concise Enterprises | Pakistan | Maker | Dental Instruments, EIY, Filling, Plastic | — | — |
| Mts Brothers Surgical Instruments | Pakistan | Maker | NSTRUMENT, FILLING, PLASTIC, DENTAL | — | — |
| NR Surgical Company | Pakistan | Maker | INSTRUMENT, FILLING, PLASTIC, DENTAL | — | — |
| Robinson Healthcare Limited | United Kingdom | Maker | Instrapac | — | — |
| Power Dental USA | United States | Maker | — | — | — |
| Trinity Sterile Inc | United States | Maker | Dental | — | — |
| Shenzhen Mold and Manufacturing Co Ltd | China | Maker | Pen | — | — |
| Ultra Surgical (Pvt.) Ltd. | Pakistan | Maker | INSTRUMENT, FILLING, PLASTIC, DENTAL | — | — |
| Peter Brasseler Holdings, LLC | United States | Maker | — | — | — |
| Swengg Co | Pakistan | Maker | Dental Plastic Filling Instruments | — | — |
| Verdent Ltd. | Poland | Maker | Verdent dental instruments | — | — |
| Zhejiang Lidesen Medical Instrument Co., Ltd | China | Maker | False tooth boxes with colander insider white | — | — |
| J&J Instruments | United States | Maker | — | — | — |
| QSA Surgical | Pakistan | Maker | — | — | — |
| Denbur Inc | United States | Maker | Fracfinder | — | — |
| Hive International Pvt Ltd. | Pakistan | Maker | Filling Instruments | — | — |
| Kohler Medizintechnik GmbH | Germany | Maker | — | — | — |
| Larident SRL | Italy | Maker | IMPLA-CLEAN | — | — |
| Surgicon Pvt Ltd | Pakistan | Maker | INSTRUMENT, FILLING, PLASTIC, DENTAL | — | — |
| Creanova doo | Serbia | Maker | OdneFill Tip | — | — |
| Song Young Intl. Co. | Taiwan | Maker | SUPERIOR MICRO-PORTABLE | — | — |
| Hermann Mueller Medizintechnik GmbH | Germany | Maker | VARIOUS TYPES OF DEN | — | — |
| Phoenix Instruments, Inc. | United States | Maker | — | — | — |
| Septodont | United States | Maker | — | — | — |
| USTOMED INSTRUMENTE GmbH & Co. KG | Germany | Maker | — | — | — |
| Baeramed Instrumente | Germany | Maker | — | — | — |
| BAK KOHLER Medical KG | Germany | Maker | — | — | — |
| Devemed GmbH | Germany | Maker | — | — | — |
| Helmut Zepf Medizintechnik GmbH | Germany | Maker | — | — | — |
| Nextcon International | Pakistan | Maker | — | — | — |
| Sinntech Medical (Private) Limited | Pakistan | Maker | — | — | — |
| DiaDent Group International | South Korea | Foreign exporter | Disposable Brushes | 24 | 2026 |
| Integra LifeSciences Corporation | United States | Contract manufacturer | Integra · Jarit · Miltex | 2 | 2014 |
| Aesculap, Inc. | United States | Lister | Aesculap | 2 | 2006 |
| A. Titan Instruments, Inc. | United States | Contract manufacturer | Plastic filling instrument | 1 | 2006 |
| One Dashcorp | United States | Repacker / relabeler | Valdent USA #4 Stainless Steel Double-End Plastic Filling Instrument, Blue coated tips. · Valdent USA Cement Spatula, Single-End | — | — |
| Wuxi Lyusmile Imp and Exp Co.,ltd | China | Private-label distributor | Amalgam Carrier · BLEACHING PEN WITH BRUSH · Blue white with Mixing well · Carbinet Tray · +39 | — | — |
| Dentimed Sao Joao LLC | United States | Repacker / relabeler | Angelus | — | — |
| TitanLinks Logistics LLC | United States | Repacker / relabeler | Dappen Dish | — | — |
| Jmu Dental, Inc. | United States | Repacker / relabeler | baby tooth box; box; plastic dappen | — | — |
| Patterson Companies, Inc. | United States | Foreign exporter | Patterson Filling Instrument | — | — |
| Soher Med Limited | Hong Kong SAR China | Foreign exporter | Instrument | — | — |
| STERIS Corporation | United States | Contract sterilizer | — | — | — |
| HSG-S Corp | United States | Manufacturer | EdgeBioCeramic Tips | — | — |
| Aspen Surgical Products | United States | Contract manufacturer | Symmetry Surgical | — | — |
| Premium Plus Dental | United States | Lister | INSTRUMENT, FILLING PLASTIC, DENTAL | — | — |
| Diadent Group Intl., Inc. | Canada | Foreign exporter | Disposable Brushes | — | — |
| Yizur Ltd | Hong Kong SAR China | Foreign exporter | Dappen Dish | — | — |
| TBS Dental | United States | Repacker / relabeler | TBS INOX USA | — | — |
| Wise Linkers LLC | United States | Repacker / relabeler | Artman Instruments | — | — |
| LLD Care d.o.o. | Croatia | Foreign exporter | PFI Instrument | — | — |
| Sklar Corporation | United States | Repacker / relabeler | Filling Instrument | — | — |
| ArtCraft Dental, Inc. | United States | Repacker / relabeler | CompPlus | — | — |
| Beaming White LLC | United States | Manufacturer | Pen | — | — |
| Ortho Solutions LC | United States | Contract manufacturer | — | — | — |
| Xplora USA LLC | United States | Manufacturer | Six Month Smiles | — | — |
| YCH Distripark Sdn Bhd | Malaysia | Foreign exporter | Aesculap | — | — |
| E A Beck & Company | United States | Repacker / relabeler | FILLING INSTRUMENT | — | — |
| ATOMO Dental, Inc. | United States | Repacker / relabeler | baby tooth box; box; plastic dappen | — | — |
| Dental Brands for Less | Canada | Foreign exporter | DENTSPLY · LOOK | — | — |
| Shanghai Hua EN Industrial Co. Ltd. | China | Foreign exporter | Plastic Filling | — | — |
| Novocol Pharmaceutical of Canada, Inc. | Canada | Foreign exporter | Ultra Safety Handle | — | — |
| Alta Smiles, Inc | United States | Manufacturer | — | — | — |
| Novo Surgical Inc. | United States | Repacker / relabeler | — | — | — |
| Kash Sales Inc. | Canada | Foreign exporter | — | — | — |
| Marina Medical Instruments | United States | Repacker / relabeler | Trocar, Pyramidal | — | — |
| Olulo LLC | United States | Repacker / relabeler | — | — | — |
| 3D Dental Designs and Development LLC | United States | Contract manufacturer | — | — | — |
| Amnotec International Medical GmbH | Germany | Repacker / relabeler | — | — | — |
| Avalign Technologies | United States | Contract manufacturer | — | — | — |
| Mainline Medical Dental Supply | Canada | Foreign exporter | — | — | — |
| Oketz Logistics LLC | United States | Repacker / relabeler | — | — | — |
510(k) clearances
| Decided | 510(k) | Device | Applicant |
|---|---|---|---|
| 27 May 1987 | K871909 | COMPOSITE RESTORATIVE CARRIER | Dentsply Intl., Inc. |
| 2 Jul 1985 | K851726 | 1760/1 TO 2010/34 VARIOUS DENTAL FILLING INSTRUMEN | Artiberia |
| 3 Jan 1984 | K833955 | NOVEL DISPENSER/PACKAGE | Dentsply Intl., Inc. |
| 28 Apr 1983 | K830776 | MICROFIL CONTOURING INSTRUMENTS | Almore Intl., Inc. |
| 24 Nov 1982 | K823323 | DENTAL INSTRUMENTS - PLASTIC INSTRUMENTS | Miltex, Inc. |
Official records: FDA product classification for EIY · 21 CFR 872.4565.
Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026