Surgical devices · 21 CFR 872 Subpart E
Dental Diamond Instrument
FDA device type “Instrument, Diamond, Dental”.
- Companies listing it
- 10463 makers
- Brands and models
- 855
- 510(k) clearances
- 210 in five years
- FDA name
- Instrument, Diamond, Dental
510(k) clearances per year, 1976–2026
Companies that list DZP
104 companies currently list this device type with FDA.
| Company | Country | Role | Brands and models listed | Clearances | Latest |
|---|---|---|---|---|---|
| Dentsply Sirona, Inc. | United States | Maker | Zircon diamond burr set | 148 | 2026 |
| Shofu Inc | Japan | Maker | — | 96 | 2025 |
| Sybron Dental Specialties | United States | Maker | All Ceramic Logic Set · Anterior Composite Logic Set · Axial Reduction - MADC · Axial Reduction Logic Set · +41 | 203 | 2026 |
| Dent4You AG | Switzerland | Maker | Alpen Diamond Instruments · Diatech Diamond Instruments | 5 | 2026 |
| Premier Dental Products Company | United States | Maker | SOLO DIAMOND | 28 | 2026 |
| Hager& Meisinger GmbH | Germany | Maker | MEISINGER Diamond Instruments · Singles | 14 | 2025 |
| Dentalez, Inc. | United States | Maker | Classique Diamond Burs | 9 | 2026 |
| Den-Mat Holdings, LLC | United States | Maker | CleanCut Extended Use Diamond · Extra-Fine Smoothing Diamond · Football Diamond · Interproximal Mosquito Diamond · +1 | 8 | 2026 |
| Coltene/Whaledent AG | Switzerland | Maker | Alpen · Alpen Diamond Instruments · Alpen Speedster Zr Plus · Alpen Z-Rex · +3 | 45 | 2022 |
| Garrison Dental Solutions LLC | United States | Maker | FitStrip | 3 | 2024 |
| Shenzhen Rogin Medical Co., Ltd. | China | Maker | DIAMOND BURS | 1 | 2025 |
| DentalMaster (Xiamen) Medical Technology Co., Ltd. | China | Maker | Carborundum burr · Crestal Approach Drill I · Crestal Approach Drill II · Lateral Approach Drill III | 1 | 2026 |
| Shenzhen Superline Technology Co Ltd | China | Maker | Diamond dental burs,NIC dental burs,SUPERLINE dental burs · Fliex · Zirconia cutting burs | 1 | 2025 |
| Bioline Dental Implant Systems Ltd | Israel | Maker | FG Diamond Dental Burs | 1 | 2025 |
| Microcopy, Div. Neo-Flo, Inc. | United States | Maker | NeoDiamond | 2 | 1989 |
| Gebr. Brasseler GmbH & Co. KG | Germany | Maker | KOMET DENTAL DIAMOND INSTRUMENTS | 1 | 2007 |
| Abrasive Technology, Inc. | United States | Maker | Priva · Prodia · Prodia Sport · Two Striper | 1 | 1990 |
| Spring Health Products, Inc. | United States | Maker | Spring Diamonds | 1 | 1999 |
| A & M Instruments, Inc. | United States | Maker | A&M Diamond Burs, LeBlond, | 1 | 1983 |
| Osung Mnd Co Ltd | South Korea | Maker | DBGLK · DBGOK · DBINK · DBMEK · +597 | — | — |
| B. Ali Impex | Pakistan | Maker | BALI · DOCTOR NICE | — | — |
| Shenzhen Denco Medical Co Ltd | China | Maker | DIAMOND BURS | — | — |
| HSG-S Corp | United States | Maker | Durabraze | — | — |
| 3R Industria e Comercio Ltda | Brazil | Maker | Instrument, Diamond, Dental - HENRY SCHEIN - MICRODONT - DIAMOND BURS | — | — |
| Falcon Surgical Co. (Pvt.) Ltd. | Pakistan | Maker | Dental Instrument, Diamond Coated | — | — |
| Nordent MFG., Inc. | United States | Maker | — | — | — |
| Dentatus AB | Sweden | Maker | Dentatus Diamond Instruments · FD | — | — |
| Beyes Dental Inc | Canada | Maker | Beyes Dental Bur | — | — |
| Mani, Inc. (Head Office) | Japan | Maker | MANI DIA-BURS | — | — |
| DFS-Diamon GmbH | Germany | Maker | 200147 Finishing & polishing kit ceramics/composites · 50500 REDUCERS HP, pu: 2pcs · 50510 REDUCERS CA, pu: 2 pcs · 50520 REDUCERS HP-FG 1,6 mm, pu: 2 pcs · +43 | — | — |
| NTI Kahla GmbH Rotary Dental Instruments | Germany | Maker | All Ceramic Supermax · Bambino Series · Brix Diamond Disc · Brix HP diamond · +22 | — | — |
| Garish Apparels | Pakistan | Maker | Tamzon Instruments Inc. | — | — |
| Shenzhen Forever Medical Devices Co., Ltd | China | Maker | Diamond burs | — | — |
| Huizhou Videya Technology Co., Ltd. | China | Maker | VDEYA, Diamond Burs, Model FG,XL,2XL,RA,BR,BC,EX,WF,WR,SF,TC,SR,TF,SI,D1,TC,TF,CR,FO,VP,CD,SO,BC,TR | — | — |
| Bioclear Matrix Systems, LLC | United States | Maker | TruContact · True Contact 2 | — | — |
| Intensiv SA | Switzerland | Maker | Intensiv Diamond Instruments FG and RA | — | — |
| Onvet Medical Canada Inc. | Canada | Maker | Markson SureFita | — | — |
| one day dental partner | South Korea | Maker | kage INSTRUMENT, DIAMOND, DENTAL | — | — |
| MDT Micro Diamond Technologies Ltd | Israel | Maker | Dental Rotary Instruments · IPR Interproximal Reduction Burs | — | — |
| Esthetic Orthodontic Company of America LLC | United States | Maker | Diamond Bur · IPR Diamond strips fine · IPR Diamond strips medium · IPR Diamond strips superfine · +1 | — | — |
| BUSCH & CO. GmbH & Co. KG | Germany | Maker | DIAMONDS | — | — |
| Edenta Etablissement | Liechtenstein | Maker | NTI | — | — |
| Peter Brasseler Holdings, LLC | United States | Maker | — | — | — |
| Diaswiss, S. A. | Switzerland | Maker | INSTRUMENT, DIAMOND, DENTAL | — | — |
| Dedeco International, Inc. | United States | Maker | Instrument Diamond Dental · Point Abrasive | — | — |
| DEPRAG High tech Materials ( Zhengzhou ) Co.,Ltd. | China | Maker | Diamond burs | — | — |
| Jota AG | Switzerland | Maker | JOTA | — | — |
| Prima Dental Group | United Kingdom | Maker | Predator Zirconia Diamonds · Prima Classic Diamonds | — | — |
| Verdent Ltd. | Poland | Maker | Verdent | — | — |
| Hopf Ringleb & Co GmbH & Cie | Germany | Maker | DIAMOND INSTRUMENT | — | — |
| ACURATA GMBH & CO. KGaA | Germany | Maker | Acurata | — | — |
| EOCA MD Pty Limited | Australia | Maker | IPR Interproximal Reduction Burs | — | — |
| Kazan Medical Instruments Plant | Russia | Maker | Diamond bur GSAP 2,3P-8C | — | — |
| Kohler Medizintechnik GmbH | Germany | Maker | — | — | — |
| Reco-Dent International Co., Ltd. | Taiwan | Maker | Dental Diamond Instrument | — | — |
| Strauss & Co. | Israel | Maker | — | — | — |
| Yammi Hummingbird Medical Technology (Suzhou) Co., Ltd. | China | Maker | DIAMOND BURS | — | — |
| Dr Hopf GmbH and Co KG | Germany | Maker | — | — | — |
| Lasco Diamond Products, Inc. | United States | Maker | Lasco Diamond Bur | — | — |
| USTOMED INSTRUMENTE GmbH & Co. KG | Germany | Maker | — | — | — |
| Dentex Dental Industrial Corp | Taiwan | Maker | — | — | — |
| Frank Dental GmbH | Germany | Maker | — | — | — |
| North Bel Intl. S.r.l. | United States | Maker | — | — | — |
| Young Innovations Inc | United States | Contract manufacturer | Johnson Promident Polishers, Finishing Srips | 23 | 2025 |
| Lares Research | United States | Manufacturer | Cybercut Diamond Dental Bur | 8 | 2022 |
| Imicryl Dis Malzemeleri Sanayi VE Ticaret AS | Türkiye | Manufacturer | DENTAL DIAMOND | 5 | 2022 |
| Amann Girrbach AG | Austria | Foreign exporter | — | 3 | 2026 |
| Dent Zar, Inc. | United States | Repacker / relabeler | DENTAL DIAMOND INSTRUMENTS | 12 | 1996 |
| Dentatus USA Ltd. | United States | Repacker / relabeler | EVA | 4 | 2004 |
| Integra LifeSciences Corporation | United States | Contract manufacturer | Jarit · Miltex · Padgett | 2 | 2014 |
| Directa AB | Sweden | Contract manufacturer | Supra disc | 1 | 2015 |
| World Class Technology Corporation | United States | Manufacturer | Diamond Disc · Interproximal Reduction (IPR) | 1 | 2019 |
| SS White Burs LLC | United States | Manufacturer | BLACK DIAMOND, GREAT WHITE Z, PIRANHA, REVELATION | 1 | 2008 |
| Sotera Health LLC | United States | Contract manufacturer | BrasselerLGI¿ · SteriPrep¿ | — | — |
| One Dashcorp | United States | Repacker / relabeler | Valdent USA FG #36823 Fine Grit Flame Shaped Diamond Burs, 10/Pk · Valdent USA FG #36823SC, TR-22SC, Needle Shaped Super Coarse Grit Diamond Burs, 10/Pk · Valdent USA FG #37918 Fine Grit Needle Shaped Diamond Burs, 10/Pk · Valdent USA FG #37923 Fine Grit Flame Shaped Diamond Burs, 10/Pk · +17 | — | — |
| Wuxi Lyusmile Imp and Exp Co.,ltd | China | Private-label distributor | BUR HOLDER · BUR RETAINER CASE · METAL BURS HOLDER · PLASTIC HOLDER | — | — |
| Dentimed Sao Joao LLC | United States | Repacker / relabeler | ANGELUS | — | — |
| TitanLinks Logistics LLC | United States | Repacker / relabeler | Instrument | — | — |
| Jmu Dental, Inc. | United States | Repacker / relabeler | INSTRUMENT, DIAMOND, DENTAL | — | — |
| Patterson Companies, Inc. | United States | Foreign exporter | Patterson Diamond Bur | — | — |
| Soher Med Limited | Hong Kong SAR China | Foreign exporter | Endo | — | — |
| STERIS Corporation | United States | Contract sterilizer | — | — | — |
| Aspen Surgical Products | United States | Contract manufacturer | Symmetry Surgical | — | — |
| Premium Plus Dental | United States | Lister | PREMIUM PLUS | — | — |
| BBF Sterilisationsservice GmbH | Germany | Contract manufacturer | Luster ® / not applicable | — | — |
| PDT Inc. | United States | Contract manufacturer | PDT | — | — |
| CARGUS International Inc. | United States | Repacker / relabeler | MARK3® Finishing & Polishing | — | — |
| Ortho Solutions LC | United States | Contract manufacturer | — | — | — |
| Toyo Medical Co. | United States | Repacker / relabeler | TOYO MEDICAL CO | — | — |
| Xplora USA LLC | United States | Manufacturer | Six Month Smiles | — | — |
| Bina Limited | Belize | Foreign exporter | DIAMIOND BUR | — | — |
| E/T Endodontic Technologies, Ltd. | Canada | Foreign exporter | MANI Dia-Burs | — | — |
| Sanicure BV | Netherlands | Foreign exporter | — | — | — |
| Alta Smiles, Inc | United States | Manufacturer | — | — | — |
| Maverick Dental, LLC | United States | Repacker / relabeler | Typhoon | — | — |
| Kash Sales Inc. | Canada | Foreign exporter | — | — | — |
| Drendel & Zweiling DIAMANT GmbH | Germany | Foreign exporter | DENTAL DIAMONDS · ECOLINE | — | — |
| TriRock Dental LLC | United States | Repacker / relabeler | TriRock Dental | — | — |
| Endo Direct, LLC | United States | Repacker / relabeler | — | — | — |
| BGS Beta-Gamma-Service GmbH & Co KG | Germany | Contract sterilizer | — | — | — |
| Imperial Trading Limited | Barbados | Foreign exporter | — | — | — |
| Innopex Limited | Canada | Foreign exporter | — | — | — |
| Mainline Medical Dental Supply | Canada | Foreign exporter | — | — | — |
| Oketz Logistics LLC | United States | Repacker / relabeler | — | — | — |
510(k) clearances
| Decided | 510(k) | Device | Applicant |
|---|---|---|---|
| 20 Apr 2012 | K120037 | BLUWHITE DIAMOND DENTAL BURS MODIFIED | Beavers Dental, Div. Sybron Canada, Ltd. |
| 16 Sep 1994 | K943841 | SOPHOS DENTAL DIAMOND | Sophos Technologic |
| 29 Aug 1994 | K940908 | DUNHALL/OMNII INTERNATIONAL ROTARY DIAMOND BURS | Dunhall Pharmaceuticals, Inc. |
| 3 Feb 1994 | K934981 | DENTAL DRILL | Eare Consulting Service |
| 16 Mar 1993 | K923757 | DENTAL DIAMOND DRILLS | Alpha Industrializacao DE Metais Ltda. |
| 14 Jan 1992 | K913651 | MANI DIA-BURS | The Lahr Consulting Group, Inc. |
| 13 Jul 1990 | K901967 | DENDIA WERK BURS AND CUTTING DISCS | Micro-Aire Surgical Instruments, Inc. |
| 9 Jul 1990 | K901262 | F.G. LASER (DENTAL BUR) | Diamond Rotary and Carbide Intl. |
| 3 Apr 1990 | K900089 | FG DIAMOND BURRS | Kab Gloves Unltd. |
| 11 Aug 1989 | K893844 | 3D DENTAL DIAMOND ROTARY INSTRUMENTS | Lustgarten Multi-Tech International, Inc. |
| 13 Feb 1989 | K885233 | NOVA DIAMOND | Microcopy, Div. Neo-Flo, Inc. |
| 9 Mar 1988 | K880179 | BEAVERS' DENTAL DIAMOND INSTRUMENTS | Beavers Dental, Div. Sybron Canada, Ltd. |
| 18 May 1987 | K871639 | DENTAL DIAMOND BURS | E&D Dental Manufacturing Co. |
| 27 Dec 1985 | K854347 | HYBRID POINTS | Shofu Inc |
| 4 Oct 1983 | K833038 | SUMMA DISK | Shofu Inc |
| 4 Oct 1983 | K832856 | GINGI CURETTAGE DIAMOND POINTS | Shofu Inc |
| 29 Sep 1983 | K832855 | TPE DIAMOND POINTS | Shofu Inc |
| 30 Dec 1980 | K802987 | JOTA DIAMOND DENTAL BURS | Swiss American Metal Craft Corp. |
| 30 Dec 1980 | K802984 | MEISINGER DIAMOND DENTAL BURS | Swiss American Metal Craft Corp. |
| 14 Jun 1978 | K780864 | DIAMOND STONES | Venture Technology, Inc. |
| 15 Nov 1976 | K760987 | DIAMOND STONES | Adp Intl., Inc. |
Official records: FDA product classification for DZP · 21 CFR 872.4535.
Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026