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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

CountryMakers
United States18
Germany11
China7
Switzerland6
Pakistan3
Israel3
Japan3
Italy2
Canada2
Taiwan2
Vietnam2
South Korea2
Brazil1
Sweden1
Liechtenstein1
Australia1
Russia1
Mexico1
United Kingdom1
Poland1

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.

MakerLocationRole510(k) clearancesLatest clearancePMA approvalsRecall eventsClass ISource
3R Industria E Comercio LtdaSao Paulo, BrazilManufacturer1March 16, 1993000api.fda.gov
Kerr CorporationPomona, CA, United StatesManufacturer1April 20, 2012000api.fda.gov
Kerr Italia, S.r.l.SCAFATI Salerno, ItalyManufacturer1April 20, 2012000api.fda.gov
A & M Instruments, Inc.Alpharetta, GA, United StatesContract manufacturer, Manufacturer0000api.fda.gov
Abrasive Technology, LLCLewis Center, OH, United StatesManufacturer0000api.fda.gov
ACURATA GMBH & CO. KGaAThurmansbang Bavaria, GermanyManufacturer0000api.fda.gov
B. Ali ImpexSIALKOT, Punjab, PakistanManufacturer0000api.fda.gov
Beyes Dental IncToronto Ontario, CanadaManufacturer0000api.fda.gov
Bioline Dental Implant Systems LtdMigdal Tefen Northern, IsraelManufacturer0000api.fda.gov
Brasseler U.S.A. Dental, LLCSavannah, GA, United StatesContract manufacturer, Manufacturer, Repackager or relabeler, Specification developer0000api.fda.gov
BUSCH & CO. GmbH & Co. KGENGELSKIRCHEN North Rhine-Westphalia, GermanyContract manufacturer, Manufacturer0000api.fda.gov
Bioclear Matrix Systems, LLCTacoma, WA, United StatesRepackager or relabeler, Specification developer0000api.fda.gov
Coltene/Whaledent AGALTSTAETTEN Sankt Gallen, SwitzerlandContract manufacturer, Manufacturer0000api.fda.gov
Coltene/Whaledent Inc.Cuyahoga Falls, OH, United StatesManufacturer0000api.fda.gov
Den-Mat Holdings, LLCLompoc, CA, United StatesComplaint file establishment, Manufacturer, Repackager or relabeler0000api.fda.gov
Dent4you AGHeerbrugg Sankt Gallen, SwitzerlandSpecification developer0000api.fda.gov
Dentalez, Inc., Stardental DivisionLancaster, PA, United StatesManufacturer, Repackager or relabeler0000api.fda.gov
Dentalmaster (xiamen) Medical Technology Co., Ltd.Xiamen Fujian, ChinaManufacturer0000api.fda.gov
Dentatus ABSPANGA Stockholm, SwedenManufacturer0000api.fda.gov
Dentex Dental Industrial Corp.New Taipei City, TaiwanManufacturer0000api.fda.gov
Dentsply LLCMilford, DE, United StatesManufacturer0000api.fda.gov
Deprag High Tech Materials ( Zhengzhou ) Co.,ltd.ZHANGZHOU Henan, ChinaManufacturer0000api.fda.gov
Dfs-Diamon GMBHRIEDENBURG Bavaria, GermanyManufacturer0000api.fda.gov
Diaswiss S.A.NYON Vaud, SwitzerlandManufacturer0000api.fda.gov
Diatech Dental IncCuyahoga Falls, OH, United StatesManufacturer0000api.fda.gov
DR. Hopf GMBH & Co. KGLANGENHAGEN Lower Saxony, GermanyManufacturer0000api.fda.gov
Dedeco International, Inc.Long Eddy, NY, United StatesManufacturer0000api.fda.gov
Edenta EtablissementSCHAANWALD Mauren, LiechtensteinManufacturer0000api.fda.gov
Eoca MD Pty LimitedDouble Bay New South Wales, AustraliaSpecification developer0000api.fda.gov
Esthetic Orthodontic Company Of America LLCSt Petersburg, FL, United StatesRepackager or relabeler, Specification developer0000api.fda.gov
Frank Dental GMBHGmund Bavaria, GermanyManufacturer0000api.fda.gov
Falcon Surgical Co. (Pvt.) Ltd.Sialkot Punjab, PakistanManufacturer0000api.fda.gov
Garish ApparelsWazirabad Punjab, PakistanManufacturer0000api.fda.gov
Garrison Dental SolutionsSpring Lake, MI, United StatesComplaint file establishment, Specification developer0000api.fda.gov
Gebr. Brasseler GMBH & Co. KGLEMGO North Rhine-Westphalia, GermanyContract manufacturer, Manufacturer0000api.fda.gov
Hager & Meisinger GMBHNEUSS North Rhine-Westphalia, GermanyManufacturer0000api.fda.gov
Hopf, Ringleb & Co. GMBH & Cie.Berlin, GermanyManufacturer0000api.fda.gov
Huizhou Videya Technology Co., Ltd.Huizhou Guangdong, ChinaExporter to the US, Manufacturer0000api.fda.gov
Intensiv SACollina d'Oro / Montagnola Ticino, SwitzerlandManufacturer0000api.fda.gov
Jota AGRUETHI, SG Sankt Gallen, SwitzerlandContract manufacturer0000api.fda.gov
Kazan Medical Instruments PlantKazan Tatarstan, RussiaManufacturer0000api.fda.gov
Kohler Medizintechnik GmbHSTOCKACH Baden-Wurttemberg, GermanyContract manufacturer, Manufacturer0000api.fda.gov
Lasco Diamond Products, Inc.Chatsworth, CA, United StatesContract manufacturer, Manufacturer0000api.fda.gov
Maillefer Instruments Holding SarlBALLAIGUES Vaud, SwitzerlandManufacturer0000api.fda.gov
Mani, Inc. (head Office)UTSUNOMIYA Tochigi, JapanManufacturer0000api.fda.gov
Mani, Inc. (takanezawa Facility)SHIOYA Tochigi, JapanContract manufacturer0000api.fda.gov
MDT Micro Diamond Technologies LtdAFULA Northern, IsraelManufacturer0000api.fda.gov
Microcopy, Division Of Neo-Flo, Inc.Kennesaw, GA, United StatesComplaint file establishment, Manufacturer0000api.fda.gov
Mani Hanoi Co. LtdThai Nguyen Province, VietnamContract manufacturer0000api.fda.gov
Nordent MFG., Inc.Elk Grove Village, IL, United StatesManufacturer, Specification developer0000api.fda.gov
North Bel Intl. SRL.PADERNO DUGNANO Milano, ItalyManufacturer0000api.fda.gov
Nti-Kahla GMBH, Rotary Dental InstrumentsKAHLA Thuringia, GermanyManufacturer0000api.fda.gov
One Day Dental PartnerSuncheon-si Jeonnam, South KoreaExporter to the US, Manufacturer0000api.fda.gov
Onvet Medical Canada IncTORONTO Ontario, CanadaManufacturer0000api.fda.gov
Osung MND Co., Ltd.Gimpo-si Gyeonggi, South KoreaManufacturer0000api.fda.gov
Ormex S. de R.L. de C.V.Yucatan Uman, MexicoContract manufacturer0000api.fda.gov
Premier Dental Products Co.Plymouth Meeting, PA, United StatesSpecification developer0000api.fda.gov
Prima Dental GroupGLOUCESTER Gloucestershire, United KingdomRemanufacturer, Repackager or relabeler0000api.fda.gov
Reco-Dent Intl. Co., Ltd.New Taipei City, TaiwanExporter to the US, Manufacturer0000api.fda.gov
Shenzhen Denco Medical Co., Ltd.Shenzhen Guangdong, ChinaContract manufacturer, Exporter to the US, Manufacturer0000api.fda.gov
Shenzhen Forever Medical Devices Co., LtdShenzhen Guangdong, ChinaContract manufacturer, Manufacturer0000api.fda.gov
Shenzhen Rogin Medical Co., Ltdshenzhen Guangdong, ChinaContract manufacturer, Exporter to the US, Manufacturer0000api.fda.gov
Shenzhen Superline Technology Co.,ltdShenzhen Guangdong, ChinaManufacturer0000api.fda.gov
Shofu Inc.FUKUINE, HIGASHIYAMA-KU Kyoto, JapanManufacturer0000api.fda.gov
Shofu Products Vietnam Co., LtdDong Van Ward Ninh Binh, VietnamManufacturer0000api.fda.gov
Spring Health Products, Inc.Norristown, PA, United StatesManufacturer0000api.fda.gov
Strauss & Co.Raanana Central, IsraelManufacturer0000api.fda.gov
Ustomed Instrumente GMBH & Co. KGTuttlingen Baden-Wurttemberg, GermanyManufacturer0000api.fda.gov
Verdent Ltd.LODZ Lodzkie, PolandManufacturer0000api.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.