Surgical devices · 21 CFR 872 Subpart E
Calculus Removal Hand Instrument
FDA device type “Instrument, Hand, Calculus Removal”.
- Companies listing it
- 6045 makers
- Brands and models
- 66
- 510(k) clearances
- 40 in five years
- FDA name
- Instrument, Hand, Calculus Removal
510(k) clearances per year, 1976–2026
Companies that list ELA
60 companies currently list this device type with FDA.
| Company | Country | Role | Brands and models listed | Clearances | Latest |
|---|---|---|---|---|---|
| Dentsply Sirona, Inc. | United States | Maker | — | 148 | 2026 |
| Premier Dental Products Company | United States | Maker | PREMIER SCALERS | 28 | 2026 |
| Lakong Medical Devices Co., Ltd. | China | Maker | Hand instruments | 2 | 2026 |
| Pacific Care Limited | Hong Kong SAR China | Maker | PREMIUM SCALER, SONIC SCALER | 1 | 2025 |
| Zumax Medical Co., Ltd. | China | Maker | Broken Instrument Removal Kit | 1 | 2026 |
| Integra LifeSciences Corporation | United States | Maker | Miltex · Tactile Tone | 2 | 2014 |
| Storz AM Mark GmbH | Germany | Maker | Scaler | 2 | 2008 |
| Ranir, LLC | United States | Maker | — | 2 | 2011 |
| Prestige Brands Holdings, Inc. | United States | Maker | Dentek Dental Pick · Dentek Dental Scaler · Dentek Oral Care Kit · The Doctor's Orapik Traveler | 1 | 2013 |
| B. Ali Impex | Pakistan | Maker | BALI · DOCTOR NICE | — | — |
| TDV Dental Ltda | Brazil | Maker | Prophylactic Strip · PROPHYLAXIS STRIP · SeptoProphy Strips | — | — |
| Aspen Surgical Products | United States | Maker | Symmetry Surgical | — | — |
| Technimen Skillers | Pakistan | Maker | INSTRUMENT HAND CALCULUS | — | — |
| Falcon Surgical Co. (Pvt.) Ltd. | Pakistan | Maker | INSTRUMENT, HAND, CALCULUS REMOVAL | — | — |
| Nordent MFG., Inc. | United States | Maker | NORDENT SCALERS | — | — |
| Lacigrus International | Pakistan | Maker | INSTRUMENT, HAND, CALCULUS REMOVAL | — | — |
| PDT Inc. | United States | Maker | PDT, Inc. | — | — |
| Adolf Schweick Hardt GmbH & Co | Germany | Maker | INSTRUMENT, HAND, CALCULUS REMOVAL | — | — |
| Confident Instruments | Pakistan | Maker | Artman Instruments | — | — |
| ZOGEAR Medical Co., Ltd. | China | Maker | INSTRUMENT, HAND, CALCULUS REMOVAL | — | — |
| Medisporex Private Limited | Pakistan | Maker | INSTRUMENT, HAND, CALCULUS REMOVAL | — | — |
| Dentag SRL | Italy | Maker | DENTAG | — | — |
| Garish Apparels | Pakistan | Maker | Tamzon Instruments Inc. | — | — |
| Hermann GmbH | Germany | Maker | CALCULUS REMOVAL | — | — |
| Shanghai Medical Instruments (Group) Ltd. Corp. | China | Maker | SCALER | — | — |
| Biopsy Fine Cut Instruments | Pakistan | Maker | INSTRUMENT F. REMOVAL OF I.U.D 12 | — | — |
| Mident Ltd | United Kingdom | Maker | Scalers | — | — |
| Teleflex | United States | Maker | CALCULUS REMOVAL · MULTIPLE CALCULUS REM · PILLING | — | — |
| Meed Skills Surgical | Pakistan | Maker | Meed Skills Surgical | — | — |
| Dentech Corp. | Japan | Maker | MIRALAY | — | — |
| S.R.R. Surgical Co | Pakistan | Maker | removal pack Sterile single use surgical | — | — |
| Hospimed Mfg | Pakistan | Maker | DENTAL HAND | — | — |
| Shenzhen Samo Technology Co.,Limited | China | Maker | Tooth cleaner, U100,U200,U300,U400,U500,U600,U700,U800,U900 | — | — |
| Dhef Inc. | Taiwan | Maker | — | — | — |
| Weihai Jieshi Commodity Manufacture Co., Ltd. | China | Maker | dental scaler ,dental pick | — | — |
| Chung Song Industrial Co. | South Korea | Maker | MOUNTED STONES · RITE DENT | — | — |
| Wenzhou Charmhome Electronic Technology Co.,Ltd | China | Maker | Sonic Pulse Pro Plaque Remover for Teeth JY01,JY02,JY03,JY05,JY06 | — | — |
| Global Dent Aids Pvt. Ltd. | India | Maker | DenTek Gum Health Advanced Cleaning Kit | — | — |
| Shurcon Manufacturing Company | China | Maker | ACCS INSTRUMENT, HAND, CALCULUS REMOVAL | — | — |
| M R Utility products Private limited | India | Maker | DenTek Oral Care Kit | — | — |
| Perfect Group Corp. Ltd. | China | Maker | — | — | — |
| Kohler Medizintechnik GmbH | Germany | Maker | — | — | — |
| Guangdong Okay Technology Co.,Ltd. | China | Maker | Dental Calculus Remover · Dental Calculus Remover ; Brand:BeastRose ; Model:YR199 | — | — |
| taizhoufupaixinxikejiyouxiangongsi | China | Maker | power-dental-flossers-C1,C2,C3,C4 | — | — |
| Coda Resources Ltd., Heze China | China | Maker | — | — | — |
| Dentamerica | United States | Repacker / relabeler | DENTAMERICA | 4 | 2010 |
| Tpc Advanced Technology, Inc. | United States | Repacker / relabeler | TPC Dental file | 3 | 2007 |
| Wuxi Lyusmile Imp and Exp Co.,ltd | China | Private-label distributor | DENTAL INSTRUMENT | — | — |
| Dentimed Sao Joao LLC | United States | Repacker / relabeler | angelus | — | — |
| TitanLinks Logistics LLC | United States | Repacker / relabeler | INSTRUMENT, HAND, CALCULUS REMOVAL | — | — |
| Yizur Ltd | Hong Kong SAR China | Foreign exporter | INSTRUMENT, HAND, CALCULUS REMOVAL | — | — |
| 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 | Implant Scaler | — | — |
| Shanghai smedent medical instrument co., ltd. | China | Foreign exporter | Polishing cup , polishing stone ,mounted stone, polishing point | — | — |
| Enova Illumination Inc. | United States | Lister | Broken Removal Kit 17mm · Broken Removal Kit 21mm, · Broken Removal Kit 25mm · Dental Tweezer (Crab-Claw-Shaped) Including One Cleaning Connector f 0.9 | — | — |
| Utopia Towels Inc. | United States | Repacker / relabeler | Utopia Brands Inc. · Utopia Care | — | — |
| Olulo LLC | United States | Repacker / relabeler | — | — | — |
| Coda Resources Ltd | United States | Lister | — | — | — |
| Oketz Logistics LLC | United States | Repacker / relabeler | — | — | — |
510(k) clearances
| Decided | 510(k) | Device | Applicant |
|---|---|---|---|
| 15 Aug 1995 | K952363 | OPUS PACEMAKERS (MODELS 4021, 4033, AND 4034) | Ela Medical, Inc. |
| 13 Mar 1986 | K854168 | TRAVENOL DISPOSABLE DENTAL SCALERS/CURETTES | Travenol Laboratories, S.A. |
| 24 Nov 1982 | K823326 | DENTAL INSTRUMENTS - CUTTING INSTRUMENT | Miltex, Inc. |
| 12 Nov 1980 | K801974 | ANALYTIC TECH. METAL POINT HEATER #3001 | Analytic Technology |
Official records: FDA product classification for ELA · 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