Data / Medical devices / Instrument, Diamond, Dental
Instrument, Diamond, Dental (DZP): 69 FDA-registered makers in 20 countries
69 establishments in 20 countries are registered with the FDA to make Instrument, Diamond, Dental (product code DZP, Class 1, 21 CFR 872.4535). 3 of them have a 510(k) clearance or PMA approval on file and 0 have a recall event. The FDA has issued 21 510(k) clearances under this code, the latest on April 20, 2012, and lists 0 recall events (0 Class I). FDA data exported November 2, 2026.
SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.
- Product code
- DZP
- Device class
- 1
- Regulation
- 872.4535
- Medical specialty
- Dental
Makers by country
| Country | Makers |
|---|---|
| United States | 18 |
| Germany | 11 |
| China | 7 |
| Switzerland | 6 |
| Pakistan | 3 |
| Israel | 3 |
| Japan | 3 |
| Italy | 2 |
| Canada | 2 |
| Taiwan | 2 |
| Vietnam | 2 |
| South Korea | 2 |
| Brazil | 1 |
| Sweden | 1 |
| Liechtenstein | 1 |
| Australia | 1 |
| Russia | 1 |
| Mexico | 1 |
| United Kingdom | 1 |
| Poland | 1 |
Makers of Instrument, Diamond, Dental
Registered establishments that manufacture, contract manufacture, remanufacture, reprocess or own the specification of this device, with the 510(k) clearances, PMA approvals and recalls the FDA files under each. Best documented first.
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| 3R Industria E Comercio Ltda | Sao Paulo, Brazil | Manufacturer | 1 | March 16, 1993 | 0 | 0 | 0 | api.fda.gov |
| Kerr Corporation | Pomona, CA, United States | Manufacturer | 1 | April 20, 2012 | 0 | 0 | 0 | api.fda.gov |
| Kerr Italia, S.r.l. | SCAFATI Salerno, Italy | Manufacturer | 1 | April 20, 2012 | 0 | 0 | 0 | api.fda.gov |
| A & M Instruments, Inc. | Alpharetta, GA, United States | Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Abrasive Technology, LLC | Lewis Center, OH, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| ACURATA GMBH & CO. KGaA | Thurmansbang Bavaria, Germany | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| B. Ali Impex | SIALKOT, Punjab, Pakistan | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Beyes Dental Inc | Toronto Ontario, Canada | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Bioline Dental Implant Systems Ltd | Migdal Tefen Northern, Israel | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Brasseler U.S.A. Dental, LLC | Savannah, GA, United States | Contract manufacturer, Manufacturer, Repackager or relabeler, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| BUSCH & CO. GmbH & Co. KG | ENGELSKIRCHEN North Rhine-Westphalia, Germany | Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Bioclear Matrix Systems, LLC | Tacoma, WA, United States | Repackager or relabeler, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Coltene/Whaledent AG | ALTSTAETTEN Sankt Gallen, Switzerland | Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Coltene/Whaledent Inc. | Cuyahoga Falls, OH, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Den-Mat Holdings, LLC | Lompoc, CA, United States | Complaint file establishment, Manufacturer, Repackager or relabeler | 0 | 0 | 0 | 0 | api.fda.gov | |
| Dent4you AG | Heerbrugg Sankt Gallen, Switzerland | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Dentalez, Inc., Stardental Division | Lancaster, PA, United States | Manufacturer, Repackager or relabeler | 0 | 0 | 0 | 0 | api.fda.gov | |
| Dentalmaster (xiamen) Medical Technology Co., Ltd. | Xiamen Fujian, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Dentatus AB | SPANGA Stockholm, Sweden | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Dentex Dental Industrial Corp. | New Taipei City, Taiwan | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Dentsply LLC | Milford, DE, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Deprag High Tech Materials ( Zhengzhou ) Co.,ltd. | ZHANGZHOU Henan, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Dfs-Diamon GMBH | RIEDENBURG Bavaria, Germany | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Diaswiss S.A. | NYON Vaud, Switzerland | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Diatech Dental Inc | Cuyahoga Falls, OH, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| DR. Hopf GMBH & Co. KG | LANGENHAGEN Lower Saxony, Germany | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Dedeco International, Inc. | Long Eddy, NY, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Edenta Etablissement | SCHAANWALD Mauren, Liechtenstein | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Eoca MD Pty Limited | Double Bay New South Wales, Australia | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Esthetic Orthodontic Company Of America LLC | St Petersburg, FL, United States | Repackager or relabeler, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Frank Dental GMBH | Gmund Bavaria, Germany | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Falcon Surgical Co. (Pvt.) Ltd. | Sialkot Punjab, Pakistan | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Garish Apparels | Wazirabad Punjab, Pakistan | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Garrison Dental Solutions | Spring Lake, MI, United States | Complaint file establishment, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Gebr. Brasseler GMBH & Co. KG | LEMGO North Rhine-Westphalia, Germany | Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Hager & Meisinger GMBH | NEUSS North Rhine-Westphalia, Germany | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Hopf, Ringleb & Co. GMBH & Cie. | Berlin, Germany | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Huizhou Videya Technology Co., Ltd. | Huizhou Guangdong, China | Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Intensiv SA | Collina d'Oro / Montagnola Ticino, Switzerland | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Jota AG | RUETHI, SG Sankt Gallen, Switzerland | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Kazan Medical Instruments Plant | Kazan Tatarstan, Russia | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Kohler Medizintechnik GmbH | STOCKACH Baden-Wurttemberg, Germany | Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Lasco Diamond Products, Inc. | Chatsworth, CA, United States | Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Maillefer Instruments Holding Sarl | BALLAIGUES Vaud, Switzerland | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Mani, Inc. (head Office) | UTSUNOMIYA Tochigi, Japan | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Mani, Inc. (takanezawa Facility) | SHIOYA Tochigi, Japan | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| MDT Micro Diamond Technologies Ltd | AFULA Northern, Israel | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Microcopy, Division Of Neo-Flo, Inc. | Kennesaw, GA, United States | Complaint file establishment, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Mani Hanoi Co. Ltd | Thai Nguyen Province, Vietnam | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Nordent MFG., Inc. | Elk Grove Village, IL, United States | Manufacturer, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| North Bel Intl. SRL. | PADERNO DUGNANO Milano, Italy | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Nti-Kahla GMBH, Rotary Dental Instruments | KAHLA Thuringia, Germany | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| One Day Dental Partner | Suncheon-si Jeonnam, South Korea | Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Onvet Medical Canada Inc | TORONTO Ontario, Canada | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Osung MND Co., Ltd. | Gimpo-si Gyeonggi, South Korea | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Ormex S. de R.L. de C.V. | Yucatan Uman, Mexico | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Premier Dental Products Co. | Plymouth Meeting, PA, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Prima Dental Group | GLOUCESTER Gloucestershire, United Kingdom | Remanufacturer, Repackager or relabeler | 0 | 0 | 0 | 0 | api.fda.gov | |
| Reco-Dent Intl. Co., Ltd. | New Taipei City, Taiwan | Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Shenzhen Denco Medical Co., Ltd. | Shenzhen Guangdong, China | Contract manufacturer, Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Shenzhen Forever Medical Devices Co., Ltd | Shenzhen Guangdong, China | Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Shenzhen Rogin Medical Co., Ltd | shenzhen Guangdong, China | Contract manufacturer, Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Shenzhen Superline Technology Co.,ltd | Shenzhen Guangdong, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Shofu Inc. | FUKUINE, HIGASHIYAMA-KU Kyoto, Japan | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Shofu Products Vietnam Co., Ltd | Dong Van Ward Ninh Binh, Vietnam | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Spring Health Products, Inc. | Norristown, PA, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Strauss & Co. | Raanana Central, Israel | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Ustomed Instrumente GMBH & Co. KG | Tuttlingen Baden-Wurttemberg, Germany | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Verdent Ltd. | LODZ Lodzkie, Poland | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated April 20, 2012. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.