Surgical devices · 21 CFR 872 Subpart E
Operative Amalgam and Foil Condenser
FDA device type “Condenser, Amalgam And Foil, Operative”.
- Companies listing it
- 5239 makers
- Brands and models
- 75
- 510(k) clearances
- 30 in five years
- FDA name
- Condenser, Amalgam And Foil, Operative
510(k) clearances per year, 1976–2026
Companies that list EKG
52 companies currently list this device type with FDA.
| Company | Country | Role | Brands and models listed | Clearances | Latest |
|---|---|---|---|---|---|
| DiaDent Group International | South Korea | Maker | DIA-KONDENSOR | 24 | 2026 |
| Shofu Inc | Japan | Maker | Condenser | 96 | 2025 |
| Premier Dental Products Company | United States | Maker | PREMIER AMALGAM CONDENSER | 28 | 2026 |
| Young Innovations Inc | United States | Maker | Obtura Spartan · S-Kondensers | 23 | 2025 |
| Hu-Friedy Mfg Co., LLC | United States | Maker | AMALGAM AND FOIL · AMALGAM PLUGGERS · Hu-Friedy Mfg Co.,LLC | 8 | 2012 |
| Osung Mnd Co Ltd | South Korea | Maker | GCP113 · GCP113N · GCP170 · GCP171 · +5 | — | — |
| Schobell Industrial Ltda | Brazil | Maker | Clev Dent condenser · Double 8mm Tapered Tip Foot · Hollenbach condenser n6 · Paiva plugger n. 2 · +7 | — | — |
| Guilin Yikeshi Medical Instrument Co Ltd | China | Maker | xp-35A · xp-35B · XP-35C | — | — |
| Cislak Manufacturing, Inc. | United States | Maker | Cislak · Zoll Dental | — | — |
| Falcon Surgical Co. (Pvt.) Ltd. | Pakistan | Maker | Condenser | — | — |
| Pomee Corporation | Pakistan | Maker | Amalgam Carriers · Amalgam Carver · Amalgam Condensers & Pluggers | — | — |
| Medcave Private Limited | Pakistan | Maker | CONDENSER | — | — |
| Nordent MFG., Inc. | United States | Maker | NORDENT AMALGAM CONDENSERS | — | — |
| Panorama International | Pakistan | Maker | CONDENSER, AMALGAM AND FOIL, OPERATIVE, Amalgam Condensers | — | — |
| Lacigrus International | Pakistan | Maker | CONDENSER, AMALGAM AND FOIL, OPERATIVE | — | — |
| Comfort Surgical Instruments | Pakistan | Maker | condenser operative | — | — |
| Aesculap AG | Germany | Maker | Aesculap | — | — |
| PDT Inc. | United States | Maker | PDT, Inc. | — | — |
| Adolf Schweick Hardt GmbH & Co | Germany | Maker | FILLING INSTRUMENTS | — | — |
| Confident Instruments | Pakistan | Maker | Artman Instruments | — | — |
| Medisporex Private Limited | Pakistan | Maker | CONDENSER AMALGAM, PLUGGER | — | — |
| Dentag SRL | Italy | Maker | DENTAG | — | — |
| Garish Apparels | Pakistan | Maker | Tamzon Instruments Inc. | — | — |
| Shenzhen Forever Medical Devices Co., Ltd | China | Maker | CONDENSER | — | — |
| Acme Enterprises | Pakistan | Maker | TBS Dental | — | — |
| W.H. Holden Inc. DBA H & H Company | United States | Maker | CONDENSERS | — | — |
| Goldman Products, Inc. | United States | Maker | Goldman · MicroDent | — | — |
| Silver Plus Corp. | Pakistan | Maker | CONDENSER, AMALGAM AND FOIL, OPERATIVE | — | — |
| Towne Brothers (Pvt) Ltd | Pakistan | Maker | EKG - CONDENSER, AMALGAM AND FOIL, OPERATIVE | — | — |
| Mident Ltd | United Kingdom | Maker | Amalgam Condensers And Pluggers | — | — |
| Acme Commercial Ways Ltd. | Pakistan | Maker | CONDENSER, AMALGAM AND FOIL, OPERATIVE | — | — |
| Dimeda Instrumente GmbH | Germany | Maker | DIMEDA | — | — |
| Pilotis Tech LLC | United States | Maker | Intrace USA | — | — |
| B. Braun Medical Industries Sdn. Bhd | Malaysia | Maker | Aesculap | — | — |
| Med2B Ltd. | Germany | Maker | CONDENSER, AMALGAM AND FOIL, OPERATIVE | — | — |
| Zepf Medical Instrum | Germany | Maker | AMALGAM AND FOIL | — | — |
| Robinson Healthcare Limited | United Kingdom | Maker | Instrapac | — | — |
| Kohler Medizintechnik GmbH | Germany | Maker | — | — | — |
| Helmut Zepf Medizintechnik GmbH | Germany | Maker | — | — | — |
| Integra LifeSciences Corporation | United States | Contract manufacturer | Integra · Jarit · Miltex | 2 | 2014 |
| Aesculap, Inc. | United States | Lister | Aesculap | 2 | 2006 |
| Dentimed Sao Joao LLC | United States | Repacker / relabeler | Angelus | — | — |
| Patterson Companies, Inc. | United States | Foreign exporter | Patterson® Condensers | — | — |
| STERIS Corporation | United States | Contract sterilizer | — | — | — |
| Aspen Surgical Products | United States | Contract manufacturer | Symmetry Surgical | — | — |
| Diadent Group Intl., Inc. | Canada | Foreign exporter | DIA-KONDENSOR | — | — |
| Wise Linkers LLC | United States | Repacker / relabeler | Artman Instruments | — | — |
| YCH Distripark Sdn Bhd | Malaysia | Foreign exporter | Aesculap | — | — |
| Sontec Instruments Inc | United States | Repacker / relabeler | Multiple | — | — |
| 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 |
|---|---|---|---|
| 19 Feb 1987 | K865025 | AUSTENAL CONDENSING INSTRUMENT | Austenal Dental, Inc. |
| 3 Dec 1984 | K843901 | ISOSTATIC CONDENSER | Shofu Inc |
| 24 Nov 1982 | K823322 | DENTAL INSTRUMENTS - PLUGGERS | Miltex, Inc. |
Official records: FDA product classification for EKG · 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