Surgical devices · 21 CFR 872 Subpart E
Operative Dental Amalgam Carver
FDA device type “Carver, Dental Amalgam, Operative”.
- Companies listing it
- 9272 makers
- Brands and models
- 181
- 510(k) clearances
- 30 in five years
- FDA name
- Carver, Dental Amalgam, Operative
510(k) clearances per year, 1976–2026
Companies that list EKH
92 companies currently list this device type with FDA.
| Company | Country | Role | Brands and models listed | Clearances | Latest |
|---|---|---|---|---|---|
| Shofu Inc | Japan | Maker | INSTRUMENT, DIAMOND, DENTAL | 96 | 2025 |
| Premier Dental Products Company | United States | Maker | PREMIER AMALGAM CARVER | 28 | 2026 |
| Young Innovations Inc | United States | Maker | AEI Carvers | 23 | 2025 |
| DentalMaster (Xiamen) Medical Technology Co., Ltd. | China | Maker | Dental Filler | 1 | 2026 |
| Hu-Friedy Mfg Co., LLC | United States | Maker | AMALGAM CARVERS · FILES · Hu-Friedy Mfg Co.,LLC | 8 | 2012 |
| Integra LifeSciences Corporation | United States | Maker | Miltex · Tactile Tone | 2 | 2014 |
| Storz AM Mark GmbH | Germany | Maker | Amalgam carver · Modelling instrument | 2 | 2008 |
| Osung Mnd Co Ltd | South Korea | Maker | CV3 · CV3S · CV74-75 · CV76-77 · +2 | — | — |
| Zain's Medical Image | Pakistan | Maker | Akers Carver · AMALGAM CARVER · Evan Wax Carver · Wax & Amalgam Carver · +9 | — | — |
| Densol International (Private) Limited | Pakistan | Maker | Cleoide Discoid Carver 4/5 HH 6mm · Half Hollenback Carver #3S DE HH 6mm · Hollenback Carver #3 DE HH 6mm · Intra Proximal Carver IPC DE HH 10mm · +2 | — | — |
| Metro Medical | Pakistan | Maker | Amalgam Carriers · Amalgam Carriers, Black, No. 0 · Amalgam Carriers, Black, No. 1 · Amalgam Carriers, Black, No. 2 · +52 | — | — |
| Shanghai Kangqiao Dental Instruments Factory | China | Maker | Amalgam carvers E1/E2/E3 (eight-angle handle) · Amalgam carvers R1/R2/R3 (round handle) · Carver For Silicone | — | — |
| B. Ali Impex | Pakistan | Maker | BALI · DOCTOR NICE | — | — |
| Prodont-Holliger | France | Maker | MODELLING SPATULA CPR03 reference 194.14SI - modeling instr. Bliss n3 · MODELLING SPATULA CPR03S regerence 194.15SI -modeling instr. Bliss n4 | — | — |
| Dental Studio | South Korea | Maker | AMALGAM BURNISHERS · AMALGAM PLUGGERS · COMPOSIT INSTRUMENTS · STOPPING STOPPER | — | — |
| Cislak Manufacturing, Inc. | United States | Maker | Cislak · Zoll Dental | — | — |
| Falcon Surgical Co. (Pvt.) Ltd. | Pakistan | Maker | Dental Carver | — | — |
| Endo Tech Instruments | Pakistan | Maker | DBL/END ANDERSON KNIFE/AMALGAN PLUGGER | — | — |
| Medcave Private Limited | Pakistan | Maker | Amalgam Carver | — | — |
| Nordent MFG., Inc. | United States | Maker | NORDENT AMALGAM CARVERS | — | — |
| Panorama International | Pakistan | Maker | CARVER, DENTAL AMALGAM, OPERATIVE | — | — |
| Shanghai Dochem Industries Co., Ltd. | China | Maker | amalgam carrier · Cuspidor Strainer · Disposable traps( filter) · Plastic retainer/ denture | — | — |
| Accompany Surgical | Pakistan | Maker | Carver · Cleoid Discoid · J&J Instruments | — | — |
| Lacigrus International | Pakistan | Maker | CARVER, DENTAL AMALGAM, OPERATIVE | — | — |
| Comfort Surgical Instruments | Pakistan | Maker | amalgam carver | — | — |
| PDT Inc. | United States | Maker | PDT, Inc. | — | — |
| Adolf Schweick Hardt GmbH & Co | Germany | Maker | CARVING INSTRUMENTS | — | — |
| Confident Instruments | Pakistan | Maker | Artman Instruments | — | — |
| Denta Craft Instruments | Pakistan | Maker | Carver; Cleoid Discoid; J&J Instruments | — | — |
| Medisporex Private Limited | Pakistan | Maker | CARVER · MEDIS | — | — |
| Dentag SRL | Italy | Maker | DenTag srl | — | — |
| Garish Apparels | Pakistan | Maker | Tamzon Instruments Inc. | — | — |
| Acme Enterprises | Pakistan | Maker | TBS Dental | — | — |
| Surgicrafts | Pakistan | Maker | EKH / CARVER, DENTAL AMALGAM, OPERATIVE | — | — |
| Acheron Instruments (Pvt.) Ltd. | Pakistan | Maker | Amalgam Carvers | — | — |
| Goldman Products, Inc. | United States | Maker | Goldman · MicroDent | — | — |
| Shanghai Medical Instruments (Group) Ltd. Corp. | China | Maker | CARVER AMALGAM | — | — |
| Surgiscape | Pakistan | Maker | CARVER, DENTAL AMALGAM, OPERATIVE | — | — |
| Choose Surgical Instruments | Pakistan | Maker | CARVER, DENTAL AMALGAM, OPERATIVE | — | — |
| Lohar Medical Company | Pakistan | Maker | EKH / CARVER, DENTAL AMALGAM, OPERATIVE | — | — |
| Mident Ltd | United Kingdom | Maker | Carver Dental Amalgam Operative | — | — |
| Nadir & Co. | Pakistan | Maker | Modeling and Waxing Carver | — | — |
| Y. Z. Corporation | Pakistan | Maker | YZ Dental Amalgam Carvers | — | — |
| Nopa Instruments Medizintechnik GmbH | Germany | Maker | LAB · ROACH CARVER | — | — |
| Surjex | Pakistan | Maker | CARVER, DENTAL AMALGAM, OPERATIVE | — | — |
| Dimeda Instrumente GmbH | Germany | Maker | DIMEDA | — | — |
| B. Braun Medical Industries Sdn. Bhd | Malaysia | Maker | Aesculap | — | — |
| Medesy Srl | Italy | Maker | medesy | — | — |
| Spartech Instruments & Co. | Pakistan | Maker | CARVER · DENTAL AMALGAM OPERATIVE | — | — |
| Med2B Ltd. | Germany | Maker | CARVER, DENTAL AMALGAM, OPERATIVE | — | — |
| Melpex Beauty Instruments | Pakistan | Maker | CARVER, DENTAL AMALGAM, OPERATIVE | — | — |
| Armatech International | Pakistan | Maker | CARVER, DENTAL AMALGAM, OPERATIVE | — | — |
| Sabokay Industries | Pakistan | Maker | Carver, Dental, Amaigam Operative | — | — |
| Darleys Surgical Co. | Pakistan | Maker | CARVER, DENTAL AMALGAM, OPERATIVE | — | — |
| Hazel Enterprises | Pakistan | Maker | CARVER, DENTAL AMALGAM, OPERATIVE | — | — |
| Surgikare | Pakistan | Maker | CARVER, DENTAL AMALGAM, OPERATIVE | — | — |
| T.A. Walthem & Company | Pakistan | Maker | CARVER, DENTAL AMALGAM, OPERATIVE | — | — |
| Washington Surgical International | Pakistan | Maker | CARVER, DENTAL AMALGAM, OPERATIVE | — | — |
| Infirmary Medical Supplies | Pakistan | Maker | CARVER, DENTAL AMALGAM OPERATIVE | — | — |
| Madina Surgical Works | Pakistan | Maker | CARVER, DENTAL AMALGAM, OPERATIVE | — | — |
| Richbolt Enterprises | Pakistan | Maker | RICHBOLT ENTERPRISES | — | — |
| Concise Enterprises | Pakistan | Maker | CARVER, DENTAL AMALGAM, OPERATIVE | — | — |
| Robinson Healthcare Limited | United Kingdom | Maker | Instrapac | — | — |
| Power Dental USA | United States | Maker | — | — | — |
| Peter Brasseler Holdings, LLC | United States | Maker | — | — | — |
| Glorious Mercantile Corp. (Pvt.) Ltd. | Pakistan | Maker | DEVICE | — | — |
| J&J Instruments | United States | Maker | Carver · Cleoid Discoid · J&J Instruments | — | — |
| Kohler Medizintechnik GmbH | Germany | 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 | — | — | — |
| J. Morita USA, Inc. | United States | Foreign exporter | Amalgam Carver | 42 | 2022 |
| Aesculap, Inc. | United States | Lister | Aesculap | 2 | 2006 |
| A. Titan Instruments, Inc. | United States | Contract manufacturer | Carver | 1 | 2006 |
| Dentimed Sao Joao LLC | United States | Repacker / relabeler | Angelus | — | — |
| TitanLinks Logistics LLC | United States | Repacker / relabeler | CARVER, DENTAL AMALGAM, OPERATIVE | — | — |
| Jmu Dental, Inc. | United States | Repacker / relabeler | DISPOSABLE TRAPS (FILTER); PLASTIC RETAINER/ DENTURE; CUSPIDOR STRAINER; AMALGAM CARRIER | — | — |
| Patterson Companies, Inc. | United States | Foreign exporter | Patterson Dental Instrument | — | — |
| STERIS Corporation | United States | Contract sterilizer | — | — | — |
| Aspen Surgical Products | United States | Contract manufacturer | Symmetry Surgical | — | — |
| Yizur Ltd | Hong Kong SAR China | Foreign exporter | CARVER, DENTAL AMALGAM, OPERATIVE | — | — |
| TBS Dental | United States | Repacker / relabeler | TBS INOX USA | — | — |
| Wise Linkers LLC | United States | Repacker / relabeler | Artman Instruments | — | — |
| Sklar Corporation | United States | Repacker / relabeler | Carver | — | — |
| Shanghai smedent medical instrument co., ltd. | China | Foreign exporter | Disposable Traps, Plastic Retainer Denture, Cuspidor Strainer | — | — |
| E A Beck & Company | United States | Repacker / relabeler | CARVER, DENTAL AMALGAM, OPERATIVE | — | — |
| ATOMO Dental, Inc. | United States | Repacker / relabeler | Disposable traps( filter); Plastic retainer/ denture; cuspidor strainer; amalgam carrier | — | — |
| Sontec Instruments Inc | United States | Repacker / relabeler | Multiple | — | — |
| Novo Surgical Inc. | 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 |
|---|---|---|---|
| 24 Nov 1982 | K823321 | DENTAL INSTRUMENTS - CARVER | Miltex, Inc. |
| 6 Jul 1982 | K821785 | BEACH AMALGAM CARVER | Pacific Dental Corp. |
| 19 Apr 1978 | K780528 | PREMIER CARVERS, STYLE #21C & 21D | Premier Dental Products Company |
Official records: FDA product classification for EKH · 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