Surgical devices · 21 CFR 872 Subpart E
Operative Dental Excavator
FDA device type “Excavator, Dental, Operative”.
- Companies listing it
- 11190 makers
- Brands and models
- 228
- 510(k) clearances
- 20 in five years
- FDA name
- Excavator, Dental, Operative
510(k) clearances per year, 1976–2026
Companies that list EKC
111 companies currently list this device type with FDA.
| Company | Country | Role | Brands and models listed | Clearances | Latest |
|---|---|---|---|---|---|
| KLS Martin SE & Co. KG | Germany | Maker | — | 43 | 2026 |
| Premier Dental Products Company | United States | Maker | PREMIER EXCAVATOR | 28 | 2026 |
| Young Innovations Inc | United States | Maker | AEI Excavators | 23 | 2025 |
| InnoBioSurg Co.,Ltd | South Korea | Maker | IBS Spoon Excavator · Spoon Excavator | 15 | 2022 |
| Dentalez, Inc. | United States | Maker | Hand Instruments - Excavators | 9 | 2026 |
| Hu-Friedy Mfg Co., LLC | United States | Maker | Hu-Friedy Mfg Co.,LLC | 8 | 2012 |
| Storz AM Mark GmbH | Germany | Maker | Excavator | 2 | 2008 |
| B&L Biotech Co., Ltd. | South Korea | Maker | JETip Instrument | 1 | 2006 |
| Osung Mnd Co Ltd | South Korea | Maker | EXC17 · EXC18 · EXC31L · EXC32L · +20 | — | — |
| ErgoDenta ApS | Denmark | Maker | Action Excavator 1.5mm · Action Excavator 1mm · Action Excavator 2mm · Action Excavator, 1.5mm · +25 | — | — |
| Zain's Medical Image | Pakistan | Maker | Dental Excavator | — | — |
| Densol International (Private) Limited | Pakistan | Maker | Dental Endo Excavators 1.2mm Round Spoon Fat Handle · Dental Endo Excavators 1.3mm Round Spoon Fat Handle · Dental Endo Excavators 1.5mm Round Spoon Fat Handle · Dental Endo Excavators 1mm Round Spoon Fat Handle · +20 | — | — |
| Metro Medical | Pakistan | Maker | Excavators, Ash · Excavators, Darby-Perry, · Excavators, White | — | — |
| Schobell Industrial Ltda | Brazil | Maker | Excavator n. 11 1/2 · Excavator n. 14 · Excavator n. 17 · Excavator n. 17/18 · +4 | — | — |
| Shanghai Kangqiao Dental Instruments Factory | China | Maker | Excavators E1/E2/E3/E4/E5/E6 (octagon handle) · Excavators KEXC 17 / KEXC 18/ KEXC31L/ KEXC32L/ KEXC33L/ KEXC L32L · Excavators R1/R2/R3/R4/R5/R6 | — | — |
| Guilin Yikeshi Medical Instrument Co Ltd | China | Maker | xp-CP-1 · xp-CP-2 · xp-CP-3 · xp-CP-L · +33 | — | — |
| B. Ali Impex | Pakistan | Maker | BALI · DOCTOR NICE · GLICK · SPOON · +1 | — | — |
| Prodont-Holliger | France | Maker | EXCAVATOR 36EX35 reference 1651SI - excavator dble n 1 Bliss · EXCAVATOR 38EX37 reference 1652SI -excavator dble n 2 Bliss · EXCAVATOR EX91 reference 1653SI -excavator dble n 3 Bliss | — | — |
| Cislak Manufacturing, Inc. | United States | Maker | Cislak · Zoll Dental | — | — |
| Falcon Surgical Co. (Pvt.) Ltd. | Pakistan | Maker | Excavator | — | — |
| Medcave Private Limited | Pakistan | Maker | Excavator | — | — |
| Nordent MFG., Inc. | United States | Maker | NORDENT EXCAVATORS | — | — |
| Panorama International | Pakistan | Maker | EXCAVATOR, DENTAL, OPERATIVE | — | — |
| Accompany Surgical | Pakistan | Maker | EXCAVATOR | — | — |
| Lacigrus International | Pakistan | Maker | EXCAVATOR, DENTAL, OPERATIVE | — | — |
| Aesculap AG | Germany | Maker | DENTAL · OPERATIVE EXCAVATOR | — | — |
| PDT Inc. | United States | Maker | PDT, Inc. | — | — |
| Adolf Schweick Hardt GmbH & Co | Germany | Maker | EXCAVATOR, DENTAL, OPERATIVE | — | — |
| Confident Instruments | Pakistan | Maker | Artman Instruments | — | — |
| Denta Craft Instruments | Pakistan | Maker | EXCAVATOR | — | — |
| Medisporex Private Limited | Pakistan | Maker | EXCAVATOR · MEDIS | — | — |
| Otto Leibinger GmbH | Germany | Maker | Excavator | — | — |
| Dentag SRL | Italy | Maker | DENTAG | — | — |
| Garish Apparels | Pakistan | Maker | Tamzon Instruments Inc. | — | — |
| Surgicrafts | Pakistan | Maker | EKC / EXCAVATOR, DENTAL, OPERATIVE | — | — |
| Acheron Instruments (Pvt.) Ltd. | Pakistan | Maker | Excavators | — | — |
| Goldman Products, Inc. | United States | Maker | Goldman · MicroDent | — | — |
| Harf Industries | Pakistan | Maker | EXCAVATOR, DENTAL, OPERATIVE · Matrix Retainer, Universal | — | — |
| Silver Plus Corp. | Pakistan | Maker | EXCAVATOR, DENTAL, OPERATIVE | — | — |
| Shanghai Medical Instruments (Group) Ltd. Corp. | China | Maker | EXCAVATOR | — | — |
| Surgiscape | Pakistan | Maker | EXCAVATOR, DENTAL, OPERATIVE | — | — |
| Towne Brothers (Pvt) Ltd | Pakistan | Maker | EKC - EXCAVATOR, DENTAL, OPERATIVE | — | — |
| Choose Surgical Instruments | Pakistan | Maker | EXCAVATOR, DENTAL, OPERATIVE | — | — |
| Lohar Medical Company | Pakistan | Maker | EKC - EXCAVATOR, DENTAL, OPERATIVE | — | — |
| Mident Ltd | United Kingdom | Maker | Operative Dental Excavator | — | — |
| Acme Commercial Ways Ltd. | Pakistan | Maker | Excavator | — | — |
| Y. Z. Corporation | Pakistan | Maker | YZ Dental Excavators | — | — |
| Daddy D Pro | Pakistan | Maker | Excavators Dental Operative | — | — |
| Crown Surgical Corp. | Pakistan | Maker | CROSURG | — | — |
| Surjex | Pakistan | Maker | EXCAVATOR DENTAL OPERATIVE, Dental Excavators | — | — |
| Pilotis Tech LLC | United States | Maker | Intrace USA | — | — |
| B. Braun Medical Industries Sdn. Bhd | Malaysia | Maker | Operative Excavator | — | — |
| Medesy Srl | Italy | Maker | medesy | — | — |
| Volgo Care International (Private) Limited | Pakistan | Maker | VOLGOCARE | — | — |
| SGS Export Intl. | Pakistan | Maker | Excavator, Dental, Operative | — | — |
| Melpex Beauty Instruments | Pakistan | Maker | EXCAVATOR, DENTAL, OPERATIVE | — | — |
| Armatech International | Pakistan | Maker | EXCAVATOR, DENTAL, OPERATIVE | — | — |
| Central Surgical Co. Pvt. Ltd. | Pakistan | Maker | EXCAVATOR, DENTAL, OPERATIVE | — | — |
| Sabokay Industries | Pakistan | Maker | Excavator, Dental, Operative | — | — |
| Darleys Surgical Co. | Pakistan | Maker | EXCAVATOR, DENTAL, OPERATIVE | — | — |
| Fabryka Narzedzi Medycznych CHIRMED Marcin Dyner Spolka Koma | Poland | Maker | Dental Operative Excavator CHIRMED | — | — |
| Hazel Enterprises | Pakistan | Maker | EXCAVATOR, DENTAL, OPERATIVE | — | — |
| Surgikare | Pakistan | Maker | EXCAVATOR, DENTAL, OPERATIVE | — | — |
| T.A. Walthem & Company | Pakistan | Maker | EXCAVATOR, DENTAL, OPERATIVE | — | — |
| Washington Surgical International | Pakistan | Maker | EXCAVATOR, DENTAL, OPERATIVE | — | — |
| Infirmary Medical Supplies | Pakistan | Maker | EXCAVATOR, DENTAL, OPERATIVE | — | — |
| Madina Surgical Works | Pakistan | Maker | EXCAVATOR, DENTAL, OPERATIVE | — | — |
| S.R.R. Surgical Co | Pakistan | Maker | Dental excavators | — | — |
| Alvi Expo | Pakistan | Maker | EXCAVATOR, DENTAL, OPERATIVE | — | — |
| Nawaz and Sons | Pakistan | Maker | EKC / EXCAVATOR, DENTAL, OPERATIVE | — | — |
| Emerald Instruments | Pakistan | Maker | EXCAVATOR, DENTAL, OPERATIVE | — | — |
| Karl Hammacher GmbH | Germany | Maker | Karl Hammacher GmbH | — | — |
| Laparomed Private Limited | India | Maker | EXCAVATORS | — | — |
| Sabri Industries | Pakistan | Maker | EXCAVATOR, DENTAL, OPERATIVE | — | — |
| Concise Enterprises | Pakistan | Maker | Excavator, Operative Instruments · Spoon Excavator, Spoon Excavator (Half Hollenback), N-Excavator, Spoon Excavator (Right Angle) | — | — |
| NR Surgical Company | Pakistan | Maker | EXCAVATOR, DENTAL, OPERATIVE | — | — |
| Robinson Healthcare Limited | United Kingdom | Maker | Instrapac | — | — |
| Tim J. Prusaitis | United States | Maker | PRU-DENT | — | — |
| Power Dental USA | United States | Maker | — | — | — |
| Peter Brasseler Holdings, LLC | United States | Maker | — | — | — |
| J&J Instruments | United States | Maker | — | — | — |
| Kohler Medizintechnik GmbH | Germany | Maker | — | — | — |
| Hermann Mueller Medizintechnik GmbH | Germany | Maker | — | — | — |
| Phoenix Instruments, Inc. | United States | Maker | — | — | — |
| USTOMED INSTRUMENTE GmbH & Co. KG | Germany | Maker | — | — | — |
| Xinhua Surgical Instrument Co.,Ltd. | China | Maker | — | — | — |
| Devemed GmbH | Germany | Maker | — | — | — |
| Helmut Zepf Medizintechnik GmbH | Germany | Maker | — | — | — |
| Nextcon International | Pakistan | Maker | — | — | — |
| Tekno-Medical Optik-Chirurgie GmbH | Germany | Maker | — | — | — |
| 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 | Excavator | 1 | 2006 |
| Dentimed Sao Joao LLC | United States | Repacker / relabeler | Angelus | — | — |
| Patterson Companies, Inc. | United States | Foreign exporter | Patterson Excavators | — | — |
| STERIS Corporation | United States | Contract sterilizer | — | — | — |
| Aspen Surgical Products | United States | Contract manufacturer | Symmetry Surgical | — | — |
| TBS Dental | United States | Repacker / relabeler | TBS INOX USA | — | — |
| Wise Linkers LLC | United States | Repacker / relabeler | Artman Instruments | — | — |
| Sklar Corporation | United States | Repacker / relabeler | Excavator | — | — |
| YCH Distripark Sdn Bhd | Malaysia | Foreign exporter | OPERATIVE EXCAVATOR | — | — |
| E A Beck & Company | United States | Repacker / relabeler | EXCAVATOR, DENTAL, OPERATIVE | — | — |
| Sontec Instruments Inc | United States | Repacker / relabeler | EXCAVATOR, DENTAL, OPERATIVE | — | — |
| ambler surgical | United States | Repacker / relabeler | Ambler Surgical | — | — |
| Hubei Lanbin Medical Group Co., Ltd. | China | Manufacturer | EXCAVATOR, DENTAL, OPERATIVE | — | — |
| HNM Medical | United States | Repacker / relabeler | HNM Medical Surgical Instrument | — | — |
| Chemo Mouthpiece, LLC D/B/A Ice Cold Mouthpiece | United States | Contract manufacturer | — | — | — |
| Novo Surgical Inc. | United States | Repacker / relabeler | — | — | — |
| Olulo LLC | United States | Repacker / relabeler | — | — | — |
| Mainline Medical Dental Supply | Canada | Foreign exporter | — | — | — |
| Oketz Logistics LLC | United States | Repacker / relabeler | — | — | — |
510(k) clearances
| Decided | 510(k) | Device | Applicant |
|---|---|---|---|
| 2 Jul 1985 | K851722 | 1285/5 TO 1295 VARIOUS TYPES OF DENTAL EXCAVATORS | Artiberia |
| 21 Feb 1984 | K834055 | VANADIUM EXCAVATORS SIZES 0-6 | Henry Schein, Inc. |
Official records: FDA product classification for EKC · 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