Surgical devices · 21 CFR 872 Subpart E
Restorative and Impression Material Syringe
FDA device type “Syringe, Restorative And Impression Material”.
- Companies listing it
- 154102 makers
- Brands and models
- 342
- 510(k) clearances
- 130 in five years
- FDA name
- Syringe, Restorative And Impression Material
510(k) clearances per year, 1976–2026
Companies that list EID
154 companies currently list this device type with FDA.
| Company | Country | Role | Brands and models listed | Clearances | Latest |
|---|---|---|---|---|---|
| Dentsply Sirona, Inc. | United States | Maker | digit · Hydrosil · Intra Oral Tips · Mixing Tips · +6 | 148 | 2026 |
| Mediclus Co., Ltd | South Korea | Maker | Disposable Tip | 15 | 2026 |
| Osstem Implant Co., Ltd. | South Korea | Maker | OSSTEM Mixing Tip · SUFLEX 50ML Impression Gun | 68 | 2026 |
| GC America Inc. | United States | Maker | Coe Syringe · GC Cartridge Dispenser II · GC Syringe · Impression Syringes · +2 | 137 | 2026 |
| Sybron Dental Specialties | United States | Maker | Automix Tips · Bayonet Rings · Dispensing Tips · Dynamic Mixing Tips · +6 | 203 | 2026 |
| Ultradent Products, Inc. | United States | Maker | Black Micro Tips · Black Mini Tips · Blue Micro Tips · Blue Mini Tips · +15 | 95 | 2026 |
| Kulzer, LLC | United States | Maker | BITE REG INTRAORAL HIP CD 96 · Flexitime dynamix mixing tips · Flow Canules · IOT White 96 · +2 | 37 | 2026 |
| Ivoclar Vivadent, AG | United States | Maker | Dispenser · Intraoral Tips · Mixing Cannulas · Mixing Tips · +8 | 94 | 2026 |
| Kuraray Noritake Dental, Inc. | Japan | Maker | CLEARFIL DC CORE PLUS Guide tip (L) · CLEARFIL DC CORE PLUS Guide tip (S) · CLEARFIL DC CORE PLUS Mixing tip · PANAVIA SA Cement Universal Automix Endo tip (SS) · +3 | 32 | 2025 |
| Inter-Med, Inc. | United States | Maker | DISPOSABLE IMPRESSION SYRINGE · Therma-Flo Composite Applicator · Therma-Flo Step-Down Tips | 7 | 2026 |
| Dent4You AG | Switzerland | Maker | Mixing Tips | 5 | 2026 |
| Shandong Huge Dental Material Corporation | China | Maker | Dispenser · Dispensing gun · Mixer · Mixer & Oral tips · +2 | 8 | 2026 |
| Premier Dental Products Company | United States | Maker | Biocoat · CompCore AF · Itena · MICRODOSE SYRINGE · +6 | 28 | 2026 |
| Young Innovations Inc | United States | Maker | Dispensing Tips · Flowthru · Implantlink Tips · Impression Material · +4 | 23 | 2025 |
| Bisco, Inc. | United States | Maker | AELITEFLO ANGLED TIPS · AELITEFLO LV TIPS · Auto-Mix Cannula Tips · BLUE TIP · +12 | 88 | 2025 |
| Centrix, Inc. | United States | Maker | AutoMix Syringe DS50, DS25 · C-R Syringe Mark I, Mark II, Mark IIIP, S/Class · C-R Syringe Snap-Fit, Snub Nose, NuGun, E/Z, Jumbo · CENTRIX SYRINGE KITS MARK I | 44 | 2025 |
| Pac-Dent Inc. | United States | Maker | — | 5 | 2022 |
| Detax GmbH | Germany | Maker | — | 2 | 2025 |
| The Belport Company, Inc. DBA Gingi-Pak | United States | Maker | — | 2 | 2026 |
| Premium Plus (Dongguan) Limited | China | Maker | Impression syringes,curved tip syringe · Intraoral Syringe Tips | 2 | 2025 |
| Lakong Medical Devices Co., Ltd. | China | Maker | Impression Syring/Material | 2 | 2026 |
| Coltene/Whaledent AG | Switzerland | Maker | Tip Dispenser | 45 | 2022 |
| Collagen Matrix, Inc. | United States | Maker | — | 20 | 2024 |
| Dreve Dentamid GmbH | Germany | Maker | Application tips · Mixing tips · Tips | 6 | 2025 |
| DMG Chemisch-Pharmazeutische Fabrik GmbH | Germany | Maker | Automix-Dispenser 50 1:1 USA · Automix-Dispenser Type 25 1:1 · Automix-Tips Blue 1:1 50 Stk U · Automix-Tips Green 1:1 50x USA · +22 | 4 | 2022 |
| Shenzhen Rogin Medical Co., Ltd. | China | Maker | Mixing Tips | 1 | 2025 |
| DentalMaster (Xiamen) Medical Technology Co., Ltd. | China | Maker | Bone Carrier · Bone Condenser | 1 | 2026 |
| Pacific Care Limited | Hong Kong SAR China | Maker | IMPRESSION SYRINGE | 1 | 2025 |
| Chemoment Materials Co.,ltd | China | Maker | Silicone Impression Material/ VPS Impression Material | 1 | 2022 |
| Pulpdent Corporation | United States | Maker | PRESSURE SYRINGE | 107 | 2021 |
| Scientific Pharmaceuticals | United States | Maker | Applicator Syringe accessory for Gel Etch | 73 | 2020 |
| Tokuyama Dental Corporation | Japan | Maker | Cement Mixing Tip · Disposable Applicator Tip and Handle · Mini Mixing Tip S · Nozzle for Mini Mixing Tip · +5 | 19 | 2021 |
| Monitex Industrial Co., Ltd. | Taiwan | Maker | Kerr | 9 | 2017 |
| Novabone Products, LLC | United States | Maker | Cartridge Applicator Gun · Cartridge Dispenser | 9 | 2011 |
| Dxm Co., Ltd. | South Korea | Maker | DX-MIXER MIXING TIPS FOR SYRINGE, RESTORATIVE AND IMPRESSION MATERIAL · EZ VPS Connector | 6 | 2020 |
| Nanova Biomaterials Inc | United States | Maker | — | 5 | 2018 |
| Premium Plus International Limited | Hong Kong SAR China | Maker | Dentmas · 078 Curved Tip Syringes · 089 Impression Syringes | 3 | 2017 |
| Bausch & Lomb Incorporated | United States | Maker | — | 3 | 1994 |
| Integra LifeSciences Corporation | United States | Maker | Integra · Miltex | 2 | 2014 |
| Lascod Spa | Italy | Maker | Algisyr | 2 | 2020 |
| Sherpa | South Korea | Maker | DXM Mixing Tips | 1 | 2011 |
| Seilglobal CO., Ltd | South Korea | Maker | Cartridge 50m · DentiAnn Imp Save Syringe · DentiAnn Impression Saver | 1 | 2015 |
| Shanghai Kangqiao Dental Instruments Factory | China | Maker | Agar impression syringes · Aspirating syringes KAS C/W2 (stainless steel) · Aspirating syringes KAS C/W3 · Aspirating syringes KAS CWA / KAS CWH · +4 | — | — |
| Debo Medical Technology (Shijiazhuang) Co., Ltd. | China | Maker | Restorative and Impression Material Syringe · THE INJECTION OF SLILCON RUBBER | — | — |
| Shenzhen Denco Medical Co Ltd | China | Maker | Mixing Tips | — | — |
| Practicon, Inc. | United States | Maker | BFC UNIT DOSE SYRINGE · BFC3 Powered Impression Gun · HP Mixing Tips · Ribbon Intraoral Tips | — | — |
| Huanghua Promisee Dental Co., Ltd | China | Maker | compule dispenser gun | — | — |
| Falcon Surgical Co. (Pvt.) Ltd. | Pakistan | Maker | Syringe, Restorative And Impression Material | — | — |
| Medcave Private Limited | Pakistan | Maker | Syringe Restorative and impression Material | — | — |
| Shanghai Jolly Industrial Co., Ltd. | China | Maker | Dental delivery tips · Dental dispenser syringe · Dispenser gun · Mixing tips | — | — |
| Lacigrus International | Pakistan | Maker | SYRINGE, RESTORATIVE AND IMPRESSION MATERIAL | — | — |
| Shanghai Lions Industrial Co., Ltd. | China | Maker | Dental delivery tips · Dental dispenser syringe · Dispenser gun · Mixing tips | — | — |
| Beyes Dental Inc | Canada | Maker | Ultranate Impression Material; Beyes Impression Syringes | — | — |
| ZOGEAR Medical Co., Ltd. | China | Maker | SYRINGE, RESTORATIVE AND IMPRESSION MATERIAL | — | — |
| Solventum US LLC | United States | Maker | — | — | — |
| Anqing Clean Dental Instrument Technology Co Ltd | China | Maker | SYRINGE, RESTORATIVE AND IMPRESSION MATERIAL | — | — |
| Hubei Guarddent Medical Technology Co.,Ltd | China | Maker | lmpression Syringe | — | — |
| Harf Industries | Pakistan | Maker | Plastic Instrument,Plastic Filling Instruments,Composite Contouring ,Goldstein Flexi-Thin Composite | — | — |
| Cangzhou Lankang Medical Instruments Developing Co., Ltd. | China | Maker | Impression Materials Mixing Tips · Plastic Intra-Oral Tips | — | — |
| Jiangsu Yabaobao Medical Instrument Co.,Ltd. | China | Maker | COMPOSITE GUN · MIXING TIP | — | — |
| Nanchang White Technology Co., Ltd. | China | Maker | Dental Impression Material | — | — |
| READY SET IMPORT dba Mynt Professional | United States | Maker | RSI Pre-Bent Dispensing Tips | — | — |
| TF New Material Sci and Tec Co.,ltd | China | Maker | Mixing tips | — | — |
| Acme Commercial Ways Ltd. | Pakistan | Maker | SYRINGE, RESTORATIVE AND IMPRESSION MATERIAL | — | — |
| Hefei Xingcheng Sanitary Products CO.,LTD | China | Maker | Disposable Curved Tip · Pre-bent applicator tips | — | — |
| HuangHua DK Dental Co., LTD, | China | Maker | Dental tip, Mixing tips | — | — |
| Zhejiang Jasmine Oralcare Products Co., Ltd. | China | Maker | Lock N Reload · Refill-Ease | — | — |
| Pilotis Tech LLC | United States | Maker | Intrace USA | — | — |
| Henan Baistra Medical Devices Limited | China | Maker | SYRINGE, RESTORATIVE AND IMPRESSION MATERIA | — | — |
| Svenska Dentorama AB | Sweden | Maker | DENTORAMA DISP. PLASTIC SYRINGE | — | — |
| CDM Center of Excellence Ltd. | China | Maker | Syringe, Restorative And Impression Material | — | — |
| LLRN Personal Care (Shenzhen) Co.,ltd | China | Maker | Dental Impression Material | — | — |
| Zhejiang Yamei Medical Equipment Technology Co., Ltd. | China | Maker | Dental Impression Material | — | — |
| Xiantao S&J Protective Products Co., Ltd | China | Maker | HP Mixing Tips, Intra Oral Tips, Dispensing Guns | — | — |
| Hefei Mlush Sanitary Products Co., Ltd | China | Maker | mixing tips | — | — |
| Jiangxi Ushine Bright Medical Co., Ltd. | China | Maker | Dental Impression Material / Silicone Impression Material | — | — |
| Dongguan Wanjin Industrial Co., Ltd | China | Maker | — | — | — |
| Tianjin Water Source Tech Co., Ltd. | China | Maker | Syringe, Restorative and Impression Material | — | — |
| Elite Dental Lab | China | Maker | silicone impression | — | — |
| Plasdent Shanghai Co., Ltd. | China | Maker | Syringe, Restorative and Impression Material | — | — |
| Shengiho Enterprise Co., Ltd. | Taiwan | Maker | PLASTIC IMPRESSION SYRINGES · Restorative & Impression Materials,Plastic Injectors,Syringe | — | — |
| ASA Dental | Italy | Maker | SCAN SYRINGE | — | — |
| medmix Deutschland GmbH | Germany | Maker | — | — | — |
| Power Dental USA | United States | Maker | SYRINGE, RESTORATIVE AND IMPRESSION MATERIAL | — | — |
| Hefei Jingcheng Plastic Products Co. Ltd | China | Maker | Syringe Restorative and Impression Material | — | — |
| Amedcon Medical Technology (Shenzhen) Co., Ltd. | China | Maker | Dispensing Tips (plastic / metal) · Empty Plastic Syringes for dental materials filling · Plastic Intra Oral Tips · Plastic Syringe Caps | — | — |
| medmix China LTD | China | Maker | Dispenser 50ml 1:1/2:1 | — | — |
| Greatcare 4u sdn bhd | Malaysia | Maker | Disposable curved tip syringe, Disposable flow tip (pre-bent multipurpose dispensing tip) | — | — |
| VastMEd LLC | United States | Maker | VASTMED EID - SYRINGE, RESTORATIVE AND IMPRESSION MATERIAL | — | — |
| Chi Feng Co.,ltd | Taiwan | Maker | BFC · Mojo | — | — |
| medmix Switzerland AG | Switzerland | Maker | SYRINGE, RESTORATIVE AND IMPRESSION MATERIAL | — | — |
| STS Corporation | United States | Maker | Syringe, Restorative Impression Material - AMTC-K - EID 1, Dental Hand Instrument | — | — |
| Anhui Chuangnuo Medical equipment Co., LTD | China | Maker | Heat Sleeve | — | — |
| BGSS Company Asia Limited | China | Maker | — | — | — |
| Exelint International Co | United States | Maker | EXEL 1ml Delivery Syringe | — | — |
| Jiangsu Caina Medical Co., Ltd | China | Maker | SYRINGE CURVED | — | — |
| Shanghai Bing Fan Industrial Co Ltd | China | Maker | HeatSleeve | — | — |
| Shanghai Kindly Enterprise Development Group Co Ltd | China | Maker | EXEL 1ml Delivery Syringe | — | — |
| USTOMED INSTRUMENTE GmbH & Co. KG | Germany | Maker | — | — | — |
| Gulmag International | Pakistan | Maker | — | — | — |
| Helmut Zepf Medizintechnik GmbH | Germany | Maker | — | — | — |
| Wuxi Yushou Medical Appliances Co Ltd | China | Maker | — | — | — |
| Prismatik Dentalcraft, Inc. | United States | Contract manufacturer | 25 Automix Applicator Tips | 56 | 2026 |
| Voco GmbH | Germany | Foreign exporter | mixing tips | 117 | 2026 |
| Zest Anchors, LLC | United States | Manufacturer | — | 26 | 2026 |
| Kettenbach GmbH & Co. KG | Germany | Manufacturer | Mucopren Accessory | 14 | 2026 |
| Park Dental Research Corp | United States | Contract manufacturer | Dental impression material | 8 | 2026 |
| Cosmedent, Inc. | United States | Repacker / relabeler | Tips | 27 | 2024 |
| Den-Mat Holdings, LLC | United States | Manufacturer | Bulkcure Tips · Dual Port Impression Gun · EndoFlex Tips · Evanesce Injectable tip · +5 | 8 | 2026 |
| DMP Dental Industry S.A. | Greece | Contract manufacturer | DMP MIXER DYNAMIC-5:1 380ml YELLOW (50) · DMP MIXER T-1:1 2.5-10-D BROWN (50) · DMP MIXER T-1:1 2.5-10-SW BLUE (50) · DMP MIXER T-1:1 3.2-12-S LIGHT BLUE (50) · +4 | 3 | 2026 |
| Keystone Industries | United States | Contract manufacturer | Bosworth Disposable Plastic Syringes · Bosworth HP Mixing Tips · Bosworth Prebent Mixing Tips · Disposable Plastic Syringes | 2 | 2025 |
| Tp Orthodontics, Inc. | United States | Manufacturer | Disposable Dispensing Tips | 5 | 2022 |
| S & C Polymer GmbH | Germany | Contract manufacturer | — | 20 | 2009 |
| Crown Delta Corp. | United States | Contract manufacturer | Impression Material Syringe | 11 | 2013 |
| Tpc Advanced Technology, Inc. | United States | Repacker / relabeler | Syringe | 3 | 2007 |
| George Taub Products & Fusion Co., Inc. | United States | Manufacturer | Tips - Auto Mix | 2 | 1986 |
| DMG America, L.L.C. | United States | Contract manufacturer | Syringe, Restorative And Impression Material - DMG Composite Dispenser | 1 | 2013 |
| Exacta Dental Products, Inc. | United States | Repacker / relabeler | EXACTA Mixing Tips | 1 | 2006 |
| One Dashcorp | United States | Repacker / relabeler | Valdent USA Blue/Clear Crown & Bridge Mixing Tips, 1:1 · Valdent USA Blue/Orange Crown & Bridge Mixing Tips, 10:1 · Valdent USA Brown HP Mixing Tips for Temporary Cement 1:1 · Valdent USA Clear Cement Mixing Tips with Intra Oral Tip, 45-Degree · +7 | — | — |
| Jersey Dental Supplies | United States | Repacker / relabeler | Penta Elastomer · SYRINGE, RESTORATIVE AND IMPRESSION MATERIAL | — | — |
| Dentimed Sao Joao LLC | United States | Repacker / relabeler | ANGELUS | — | — |
| TitanLinks Logistics LLC | United States | Repacker / relabeler | Mixing tips | — | — |
| Jmu Dental, Inc. | United States | Repacker / relabeler | DYNAMIC HP MIXING TIPS; BENT NEEDLE TIPS; CURVED UTILITY SYRINGE; DISPENSING TIPS; IMPRESSION GUN; INTRA-ORAL TIPS | — | — |
| Patterson Companies, Inc. | United States | Foreign exporter | Patterson Restorative Syringe | — | — |
| Soher Med Limited | Hong Kong SAR China | Foreign exporter | Mixing Tips | — | — |
| HSG-S Corp | United States | Manufacturer | — | — | — |
| Aspen Surgical Products | United States | Contract manufacturer | Symmetry Surgical | — | — |
| Premium Plus Dental | United States | Lister | Premium Plus Curved Tip Syringes · Premium Plus Impression Syringe · Premium Plus Interoral Syringe Tips · Premium Plus Mixer Cement Syringe Tips ,Mixing Well and Cups | — | — |
| CARGUS International Inc. | United States | Repacker / relabeler | MARK3 HP Mixing Tips, Intra-Oral Tips Dynamic Tips & Dispensing Gun. · MARK3® Dynamic Mixer · MARK3® HP Mixing Tips · MARK3® Intraoral Mixing Tips | — | — |
| LLD Care d.o.o. | Croatia | Foreign exporter | Syringe Tips | — | — |
| Unisource Shanghai Ltd. | China | Foreign exporter | Lock N Reload · Refill-Ease | — | — |
| battech | United States | Repacker / relabeler | Impression tips, Impression gun | — | — |
| Maxill Inc. | United States | Foreign exporter | Maxill Dynamic Mixing Tips · Maxill Dynamic Mixing Tips Intraoral Extensions · Maxill Mixing Tips | — | — |
| Plasdent Corporation | United States | Repacker / relabeler | Plastic Impression Syringes, Plastic injectors, Material Carrier, Syringe Tips, Mixing & Intraoral tips, Dispenser Guns | — | — |
| ATOMO Dental, Inc. | United States | Repacker / relabeler | Dynamic HP Mixing Tips; Bent Needle Tips; Curved Utility Syringe; Dispensing Tips; Impression Gun; Intra-Oral Tips | — | — |
| Dukal Corporation | United States | Specification developer | Unipack Pre-Bent Dispensing Tips | — | — |
| Shanghai Hua EN Industrial Co. Ltd. | China | Foreign exporter | UniPack | — | — |
| HI Medical Co., Ltd. | South Korea | Foreign exporter | GC | — | — |
| Sanicure BV | Netherlands | Foreign exporter | — | — | — |
| Peter Brasseler Holdings, LLC | United States | Contract manufacturer | — | — | — |
| Tianjin Medicines & Health Products Imp. & Exp. Corp. | China | Foreign exporter | Plastic Injectors | — | — |
| RTI Surgical, Inc. (dba RTI Biologics, Inc.) | United States | Manufacturer | component of dbm product | — | — |
| HEXA Dental | United States | Contract manufacturer | HEXA | — | — |
| indigodental GmbH | Germany | Foreign exporter | — | — | — |
| Opa Dental, LLC | United States | Repacker / relabeler | — | — | — |
| Shanghai Carelife International Trading Co. LTD | China | Foreign exporter | Plastic cleaning tips · Plastic tips · Plastic utility tubes | — | — |
| Dreve America Corp. | United States | Manufacturer | Multiple | — | — |
| Global-Tec Enterprises, Inc. | United States | Repacker / relabeler | Jiangyin | — | — |
| 3D Dental Designs and Development LLC | United States | Contract manufacturer | — | — | — |
| Bright Supply Inc | United States | Lister | — | — | — |
| Shanghai Medicines & Health Products Imp. & Exp. Co., Ltd. | China | Foreign exporter | — | — | — |
| 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 | — | — | — |
510(k) clearances
| Decided | 510(k) | Device | Applicant |
|---|---|---|---|
| 12 Jul 1994 | K941431 | BONE GRAFT DELIVERY SYRINGES | Bio-Interfaces, Inc. |
| 25 Feb 1992 | K913974 | ACCESS IMPRESSION BARREL | Centrix, Inc. |
| 16 Sep 1987 | K873153 | CAULK'S VPS CARTRIDGE SYSTEM | Dentsply Intl., Inc. |
| 5 Jun 1987 | K871937 | IMPRESSION SYRINGE | Dentsply Intl., Inc. |
| 30 Oct 1986 | K863998 | COLTENE JET-MIXER | Coltene AG |
| 23 Aug 1985 | K853282 | CENTRIX RIBBON TUBES | Centrix, Inc. |
| 29 Apr 1985 | K851386 | UNITEK DISPOSABLE IMPRESSION SYRINGE | Unitek Corp. |
| 6 Oct 1981 | K812680 | G-C IMPRESSION SYRINGE | G-C Intl. Corp. |
| 8 Sep 1981 | K812277 | PRISMA-FIL COMPULES | Caulk Co., Div. Dentsply |
| 28 Jul 1981 | K811582 | THE PLACER | Cavitron Corp. |
| 20 Dec 1978 | K781977 | APPLICATOR, LEE IMPRESSION | Lee Pharmaceuticals |
| 3 Jun 1977 | K770931 | APPLIC SYSTEM APPLIER, ESPE | Espe GmbH (Us) |
| 2 Jun 1977 | K770941 | APPLIC SYSTEM ACTIVATOR, ESPE | Espe GmbH (Us) |
Official records: FDA product classification for EID · 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