Surgical devices · 21 CFR 872 Subpart E
Operative Amalgam Carrier
FDA device type “Carrier, Amalgam, Operative”.
- Companies listing it
- 9070 makers
- Brands and models
- 111
- 510(k) clearances
- 20 in five years
- FDA name
- Carrier, Amalgam, Operative
510(k) clearances per year, 1976–2026
Companies that list EKI
90 companies currently list this device type with FDA.
| Company | Country | Role | Brands and models listed | Clearances | Latest |
|---|---|---|---|---|---|
| Mediclus Co., Ltd | South Korea | Maker | Ezi-Stick · Ezi-Stick plus | 15 | 2026 |
| Inter-Med, Inc. | United States | Maker | MTA CARRIER | 7 | 2026 |
| Premier Dental Products Company | United States | Maker | AMALGAM | 28 | 2026 |
| Pulpdent Corporation | United States | Maker | PCA AMALGAM CARRIERS | 107 | 2021 |
| Angelus Industria DE Produtos Odontologicos S/A | Brazil | Maker | MTA Applicator · SPEED GUN | 11 | 2021 |
| Buffalo Dental Mfg. Co., Inc. | United States | Maker | FEATHERWEIGHT · MILLENIUM | 11 | 1996 |
| Hu-Friedy Mfg Co., LLC | United States | Maker | Hu-Friedy Mfg Co.,LLC | 8 | 2012 |
| Integra LifeSciences Corporation | United States | Maker | Jarit · Miltex · Padgett | 2 | 2014 |
| Storz AM Mark GmbH | Germany | Maker | Amalgam carrier | 2 | 2008 |
| B&L Biotech Co., Ltd. | South Korea | Maker | MTA Carrier JM3JM4 | 1 | 2006 |
| A. Titan Instruments, Inc. | United States | Maker | Amalgam carrier | 1 | 2006 |
| Osung Mnd Co Ltd | South Korea | Maker | PLGWL1 · PM1520 · PM2025 · PM2030 | — | — |
| Zain's Medical Image | Pakistan | Maker | AMALGAM CARRIER, DENTAL · Amalgam Carrier, Regular/Jumbo · Amalgam Carrier, Regular/Large · Amalgam Carrier, Regular/Regular · +3 | — | — |
| Metro Medical | Pakistan | Maker | Cotton Carriers, Frohn, · Cotton Carriers, Lathbury (Farrell) | — | — |
| Signor Seven International | Pakistan | Maker | Amalgam Carrier 1.5mm/2mm diameter, Small/Medium SKU 13-1252 · Amalgam Carrier 2mm/3mm diameter, Medium/Jumbo SKU 13-1256 · Amalgam carrier with medium and large size SKU 13-1253 · Amalgam Carrier, 20mm and 2.75mm, Regular/Jumbo SKU 13-1251 · +8 | — | — |
| Shanghai Kangqiao Dental Instruments Factory | China | Maker | Amalgam carrier brass KAC A · Amalgam carrier stainless steel KAC B · Amalgam pluggers E1/E1.5/E2/E2.5/E3/E1-2/E1.5-2.5/E3×1-1×3 (eight-angle handle) · Amalgam pluggers R1 / R1.5 / R2 / R2.5 / R3 (round handle) · +1 | — | — |
| Debo Medical Technology (Shijiazhuang) Co., Ltd. | China | Maker | Operative Amalgam Carrier | — | — |
| B. Ali Impex | Pakistan | Maker | BALI · DoctorNice | — | — |
| Dental Studio | South Korea | Maker | AMALGAM CARRIERS | — | — |
| Falcon Surgical Co. (Pvt.) Ltd. | Pakistan | Maker | Amalgam Carrier | — | — |
| Commic Surgico | Pakistan | Maker | Amalgam carrier DE 3/3.5 mm · CARRIER, AMALGAM, OPERATIVE | — | — |
| Medcave Private Limited | Pakistan | Maker | Carrier Amalgam | — | — |
| Panorama International | Pakistan | Maker | CARRIER, AMALGAM, OPERATIVE | — | — |
| Accompany Surgical | Pakistan | Maker | AMALGAM | — | — |
| Comfort Surgical Instruments | Pakistan | Maker | Amalgam Carrier | — | — |
| Aesculap AG | Germany | Maker | Aesculap | — | — |
| Adolf Schweick Hardt GmbH & Co | Germany | Maker | AMALGAM CARRIER | — | — |
| Confident Instruments | Pakistan | Maker | Artman Instruments | — | — |
| Denta Craft Instruments | Pakistan | Maker | AMALGAM | — | — |
| ZOGEAR Medical Co., Ltd. | China | Maker | CARRIER, AMALGAM, OPERATIVE | — | — |
| Medisporex Private Limited | Pakistan | Maker | MEDIS | — | — |
| Garish Apparels | Pakistan | Maker | Tamzon Instruments Inc. | — | — |
| Acme Enterprises | Pakistan | Maker | TBS Dental | — | — |
| Surgicrafts | Pakistan | Maker | EKI / CARRIER, AMALGAM, OPERATIVE | — | — |
| W.H. Holden Inc. DBA H & H Company | United States | Maker | CARRIER, ALMALGAM | — | — |
| G.A. Surgical (Pvt.) Ltd. | Pakistan | Maker | AMALGAM CRRIER | — | — |
| Silver Plus Corp. | Pakistan | Maker | CARRIER, AMALGAM | — | — |
| Shanghai Medical Instruments (Group) Ltd. Corp. | China | Maker | AMALGAM CARRIER | — | — |
| Surgiscape | Pakistan | Maker | CARRIER, AMALGAM, OPERATIVE | — | — |
| Towne Brothers (Pvt) Ltd | Pakistan | Maker | EKI - CARRIER, AMALGAM, OPERATIVE | — | — |
| Choose Surgical Instruments | Pakistan | Maker | CARRIER, AMALGAM, OPERATIVE | — | — |
| Lohar Medical Company | Pakistan | Maker | EKI / CARRIER, AMALGAM, OPERATIVE | — | — |
| Mident Ltd | United Kingdom | Maker | Amalgam Carrier | — | — |
| Acme Commercial Ways Ltd. | Pakistan | Maker | Carrier, Amalgam Operative | — | — |
| Produits Dentaires SA | Switzerland | Maker | MAP One · MAP System | — | — |
| Y. Z. Corporation | Pakistan | Maker | YZ Amalgam Carriers | — | — |
| Daddy D Pro | Pakistan | Maker | Amalgam Carriers | — | — |
| Mount Blonck Trading | Pakistan | Maker | CARRIER, AMALGAM, OPERATIVE | — | — |
| Crown Surgical Corp. | Pakistan | Maker | CROSURG | — | — |
| Dimeda Instrumente GmbH | Germany | Maker | DIMEDA | — | — |
| Pilotis Tech LLC | United States | Maker | Intrace USA | — | — |
| Medesy Srl | Italy | Maker | medesy | — | — |
| Mian Shahid Corp. | Pakistan | Maker | CARRIER, AMALGAM, OPERATIVE | — | — |
| Med2B Ltd. | Germany | Maker | CARRIER, AMALGAM, OPERATIVE | — | — |
| Hazel Enterprises | Pakistan | Maker | AMALGAM CARRIER, DENTAL; Amalgam Carrier, Regular/Jumbo; Amalgam Carrier/Amalgam Well Non Slip | — | — |
| Washington Surgical International | Pakistan | Maker | AMALGAM CARRIER, DENTAL; Amalgam Carrier, Regular/Jumbo; Amalgam Carrier/Amalgam Well Non Slip | — | — |
| Madina Surgical Works | Pakistan | Maker | CARRIER, AMALGAM, OPERATIVE | — | — |
| Alvi Expo | Pakistan | Maker | CARRIER, AMALGAM, OPERATIVE | — | — |
| Richbolt Enterprises | Pakistan | Maker | RICHBOLT ENTERPRISES | — | — |
| Sabri Industries | Pakistan | Maker | CARRIER, AMALGAM, OPERATIVE | — | — |
| Zepf Medical Instrum | Germany | Maker | AMALGAM | — | — |
| Power Dental USA | United States | Maker | CARRIER, AMALGAM, OPERATIVE | — | — |
| J&J Instruments | United States | Maker | — | — | — |
| S.G. Manufacturers | Pakistan | Maker | CARRIER, AMALGAM, OPERATIVE | — | — |
| Phoenix Instruments, Inc. | United States | Maker | — | — | — |
| USTOMED INSTRUMENTE GmbH & Co. KG | Germany | Maker | — | — | — |
| Xinhua Surgical Instrument Co.,Ltd. | China | Maker | — | — | — |
| Devemed GmbH | Germany | Maker | — | — | — |
| Faulhaber Pinzetten KG | Germany | Maker | — | — | — |
| Helmut Zepf Medizintechnik GmbH | Germany | Maker | — | — | — |
| Pac-Dent Inc. | United States | Contract manufacturer | — | 5 | 2022 |
| Biomet Microfixation | United States | Manufacturer | Carrier | 8 | 2021 |
| Aesculap, Inc. | United States | Lister | Aesculap | 2 | 2006 |
| Dentimed Sao Joao LLC | United States | Repacker / relabeler | Angelus | — | — |
| TitanLinks Logistics LLC | United States | Repacker / relabeler | Carrier Amalgam | — | — |
| Patterson Companies, Inc. | United States | Foreign exporter | Patterson Carrier Amalgum Steel | — | — |
| HSG-S Corp | United States | Manufacturer | EdgeUtopia RRM Dispensing Gun | — | — |
| Aspen Surgical Products | United States | Contract manufacturer | Symmetry Surgical | — | — |
| Cislak Manufacturing, Inc. | United States | Contract manufacturer | Cislak · Zoll Dental | — | — |
| Nordent MFG., Inc. | United States | Contract manufacturer | Nordent Amalgam Carrier | — | — |
| PDT Inc. | United States | Contract manufacturer | PDT | — | — |
| Yizur Ltd | Hong Kong SAR China | Foreign exporter | Amalgam Carrier | — | — |
| 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 | — | — | — |
| Sklar Corporation | United States | Repacker / relabeler | Carrier | — | — |
| Novo Surgical Inc. | United States | Repacker / relabeler | — | — | — |
| Mainline Medical Dental Supply | Canada | Foreign exporter | — | — | — |
| Oketz Logistics LLC | United States | Repacker / relabeler | — | — | — |
| Vehu Medical Instrumente GmbH | Germany | Repacker / relabeler | — | — | — |
510(k) clearances
| Decided | 510(k) | Device | Applicant |
|---|---|---|---|
| 11 Jan 1995 | K945220 | AMALGAM CARRIER | Buffalo Dental Mfg. Co., Inc. |
| 30 Jun 1978 | K781034 | PREMIER INLAY PLACER | Premier Dental Products Company |
Official records: FDA product classification for EKI · 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