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Data / Medical devices / Drill, Dental, Intraoral

Drill, Dental, Intraoral (DZA): 143 FDA-registered makers in 21 countries

143 establishments in 21 countries are registered with the FDA to make Drill, Dental, Intraoral (product code DZA, Class 1, 21 CFR 872.4130). 0 of them have a 510(k) clearance or PMA approval on file and 0 have a recall event. The FDA has issued 13 510(k) clearances under this code, the latest on June 25, 1999, and lists 3 recall events (0 Class I). FDA data exported November 2, 2026.

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Product code
DZA
Device class
1
Regulation
872.4130
Medical specialty
Dental

Makers by country

CountryMakers
South Korea30
United States20
China20
Germany15
Israel11
Pakistan9
Switzerland6
Taiwan5
France5
Brazil4
Italy4
Japan4
Sweden2
Hong Kong1
Turkey1
Liechtenstein1
United Kingdom1
Russia1
Vietnam1
Denmark1
Hungary1

Makers of Drill, Dental, Intraoral

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
A.B. Dental Devices LtdAshdod Southern, IsraelManufacturer0000api.fda.gov
ACH Medical Co., Ltd.Hwaseong-si Gyeonggi, South KoreaManufacturer0000api.fda.gov
Alliance Global Technology Co., Ltd.Kaohsiung, TaiwanManufacturer0000api.fda.gov
Angelus Industria De Productos OdontologicosLONDRINA Parana, BrazilManufacturer0000api.fda.gov
AnthogyrSALLANCHES Haute-Savoie, FranceManufacturer0000api.fda.gov
Arnold Tuber IndustriesOrchard Park, NY, United StatesManufacturer0000api.fda.gov
ARUM DENTISTRY Co., Ltd.Yuseong-gu Daejeon, South KoreaManufacturer0000api.fda.gov
B. Ali ImpexSIALKOT, Punjab, PakistanManufacturer0000api.fda.gov
Bicon, LLCBoston, MA, United StatesSpecification developer0000api.fda.gov
Bio Composants Medicaux (BCM)SAINT BLAISE DU BUIS Isere, FranceContract manufacturer, Manufacturer0000api.fda.gov
Bio Concept Co., Ltd.Changzhou Jiangsu, ChinaManufacturer0000api.fda.gov
Bioloren SRLSARONNO Varese, ItalyManufacturer0000api.fda.gov
Biotem Co., Ltd.Busan, South KoreaManufacturer0000api.fda.gov
Brasseler U.S.A. Dental, LLCSavannah, GA, United StatesContract manufacturer, Manufacturer, Repackager or relabeler, Specification developer0000api.fda.gov
Bredent GMBH & Co.kgSENDEN Bavaria, GermanyManufacturer0000api.fda.gov
CDM Center Of Excellence Ltd.Beijing, ChinaManufacturer0000api.fda.gov
Chengdu Besmile Medical Technology Co., Ltd.Chengdu Sichuan, ChinaManufacturer0000api.fda.gov
COHO Advanced Materials Tech. Co., Ltd.Luzhu District Taoyuan, TaiwanManufacturer0000api.fda.gov
Coltene/Whaledent Inc.Cuyahoga Falls, OH, United StatesManufacturer0000api.fda.gov
Comfort Surgical InstrumentsSialkot Punjab, PakistanManufacturer0000api.fda.gov
Cortex Dental Implants Industries Ltd.Shlomi Northern, IsraelManufacturer0000api.fda.gov
Cowellmedi Co., Ltd.Busan, South KoreaManufacturer0000api.fda.gov
Creative Endodontic Technology LLCOrmond Beach, FL, United StatesSpecification developer0000api.fda.gov
Cybermed Inc.Daejeon, South KoreaManufacturer0000api.fda.gov
D.S.P. Industrial Eireli EppCampo Largo Parana, BrazilManufacturer0000api.fda.gov
Debo Medical Technology (shijiazhuang) Co., Ltd.Shijiazhuang Hebei, ChinaContract manufacturer, Exporter to the US, Foreign private label distributor, Manufacturer, Repackager or relabeler0000api.fda.gov
Dental Morelli Ltda.SOROCABA Sao Paulo, BrazilManufacturer0000api.fda.gov
Dentalmaster (xiamen) Medical Technology Co., Ltd.Xiamen Fujian, ChinaManufacturer0000api.fda.gov
Dentatus ABSPANGA Stockholm, SwedenManufacturer0000api.fda.gov
Dentech Corp.Tokyo, JapanManufacturer0000api.fda.gov
Dentin Implants Technologies Ltd.Mizpe Aviv Northern, IsraelManufacturer0000api.fda.gov
Dentsply LLCMilford, DE, United StatesManufacturer0000api.fda.gov
Dhef Inc.New Taipei City, TaiwanManufacturer0000api.fda.gov
Diadent Group InternationalCHONGJU CITY Chungbuk, South KoreaManufacturer0000api.fda.gov
Diaswiss S.A.NYON Vaud, SwitzerlandManufacturer0000api.fda.gov
Digital Arches Inc.Fountain Valley, CA, United StatesComplaint file establishment, Specification developer0000api.fda.gov
Digital Dental Depotzhuhai Guangdong, ChinaContract manufacturer, Manufacturer, Repackager or relabeler0000api.fda.gov
Digital Dental Depot LimitedHong Kong, Hong KongContract manufacturer, Exporter to the US, Manufacturer0000api.fda.gov
DIMPLO Ltd.Yeonje-gu Busan, South KoreaManufacturer0000api.fda.gov
DIO CorporationHaeundae-gu Busan, South KoreaManufacturer0000api.fda.gov
Directa ABUPPLANDS VAESBY Stockholm, SwedenManufacturer0000api.fda.gov
Doiff Co., Ltd.Suncheon-si, Jeollanam-do Jeonnam, South KoreaManufacturer0000api.fda.gov
DPM Usa Corp.Doral, FL, United StatesManufacturer0000api.fda.gov
Dti Implant SystemsKocaeli, TurkeyManufacturer0000api.fda.gov
Dunamis Dental Co., Ltd.Gwangmyeong-si Gyeonggi, South KoreaExporter to the US, Manufacturer0000api.fda.gov
Dentaurum GmbH & Co. KGISPRINGEN Baden-Wurttemberg, GermanyManufacturer0000api.fda.gov
E. Hahnenkratt GMBHKOENIGSBACH-STEIN Baden-Wurttemberg, GermanyManufacturer0000api.fda.gov
Edenta EtablissementSCHAANWALD Mauren, LiechtensteinManufacturer0000api.fda.gov
FAIRFAX MEDICAL PRODUCTS LtdLondon London, City of, United KingdomManufacturer0000api.fda.gov
FKG Dentaire SarlLE CRET-DU-LOCLE Neuchatel, SwitzerlandManufacturer0000api.fda.gov
Frank Dental GMBHGmund Bavaria, GermanyManufacturer0000api.fda.gov
Falcon Surgical Co. (Pvt.) Ltd.Sialkot Punjab, PakistanManufacturer0000api.fda.gov
Funing Meitedental FactoryYancheng Jiangsu, ChinaManufacturer0000api.fda.gov
GC Corp.ITABASHI-KU Tokyo, JapanManufacturer0000api.fda.gov
Gebr. Brasseler GMBH & Co. KGLEMGO North Rhine-Westphalia, GermanyContract manufacturer, Manufacturer0000api.fda.gov
Garana Industries Private LimitedSIALKOT Punjab, PakistanContract manufacturer, Manufacturer0000api.fda.gov
Hager & Meisinger GMBHNEUSS North Rhine-Westphalia, GermanyManufacturer0000api.fda.gov
Hans KoreaPaju-si Gyeonggi, South KoreaManufacturer0000api.fda.gov
Hefei Mlush Sanitary Products Co.,ltdHefei Anhui, ChinaManufacturer0000api.fda.gov
Helmut Zepf Medizintechnik GMBHSEITINGEN Baden-Wurttemberg, GermanyManufacturer0000api.fda.gov
Hospimed MFGSialkot Punjab, PakistanManufacturer0000api.fda.gov
Henan Lusterdent Medical Instrument Co.,LtdZhengzhou Henan, ChinaManufacturer0000api.fda.gov
Ilumi Sciences IncChantilly, VA, United StatesManufacturer0000api.fda.gov
Innobiosurg Co., Ltd.Daejeon, South KoreaManufacturer0000api.fda.gov
Intai Technology Corp. Implants Business UnitTaichung City, TaiwanComplaint file establishment, Contract manufacturer, Manufacturer0000api.fda.gov
Iq Implants LtdOmer Southern, IsraelManufacturer, Specification developer0000api.fda.gov
Izenimplant Co., Ltd.Hwaseong-si Gyeonggi, South KoreaManufacturer0000api.fda.gov
Izenimplant Co., Ltd.Pyeongtaek-si Gyeonggi, South KoreaManufacturer0000api.fda.gov
Itena Clinical VillepinteVillepinte Seine-Saint-Denis, FranceSpecification developer0000api.fda.gov
JINTAIK (Yunnan) BIOTECH CO., LTD.Kunming Yunnan, ChinaManufacturer0000api.fda.gov
JJGC Industria e Comercio de Materiais Dentarios SACuritiba Parana, BrazilManufacturer0000api.fda.gov
Josef Ganter Feinmechanik GMBHDAUCHINGEN Baden-Wurttemberg, GermanyContract manufacturer0000api.fda.gov
Jota AGRUETHI, SG Sankt Gallen, SwitzerlandContract manufacturer0000api.fda.gov
Kaiser Precision Co.Hwaseong Gyeonggi, South KoreaManufacturer0000api.fda.gov
Kazan Medical Instruments PlantKazan Tatarstan, RussiaManufacturer0000api.fda.gov
Khoury Dent Ltd Via Kasko K.N LtdKarmiel Northern, IsraelContract manufacturer0000api.fda.gov
Keystone Dental Inc.Irvine, CA, United StatesManufacturer0000api.fda.gov
Lacigrus InternationalSialkot Punjab, PakistanManufacturer0000api.fda.gov
Lakong Medical Devices Co., Ltd.Dongguan Guangdong, ChinaManufacturer0000api.fda.gov
LISI MEDICAL RemmeleCoon Rapids, MN, United StatesContract manufacturer0000api.fda.gov
Maillefer Instruments Holding SarlBALLAIGUES Vaud, SwitzerlandContract manufacturer, Manufacturer0000api.fda.gov
Mani, Inc. (head Office)UTSUNOMIYA Tochigi, JapanManufacturer0000api.fda.gov
Mani, Inc. (takanezawa Facility)SHIOYA Tochigi, JapanContract manufacturer0000api.fda.gov
MctbioYongin-si Gyeonggi, South KoreaManufacturer0000api.fda.gov
Medcare Solutions GMBHEmmingen Baden-Wurttemberg, GermanyContract manufacturer0000api.fda.gov
Medimecca Co LtdSeoul, South KoreaManufacturer0000api.fda.gov
My Implant Business GMBHHamm North Rhine-Westphalia, GermanyManufacturer0000api.fda.gov
Mani Hanoi Co. LtdThai Nguyen Province, VietnamContract manufacturer0000api.fda.gov
MegaGen Implant Co., Ltd. (Research Laboratories)Daegu, South KoreaSpecification developer0000api.fda.gov
Megagen Implant Co., Ltd.Daegu, South KoreaManufacturer0000api.fda.gov
Neobiotech Co., Ltd.Wonju-si Gangwon, South KoreaManufacturer0000api.fda.gov
Nextcon InternationalSialkot Punjab, PakistanContract manufacturer, Manufacturer0000api.fda.gov
Noga Medical Products Ltd.SHLOMI Northern, IsraelManufacturer0000api.fda.gov
Noris Medical Ltd.Nesher Haifa, IsraelManufacturer0000api.fda.gov
Nova Implants LtdOr-Yehuda Tel Aviv, IsraelSpecification developer0000api.fda.gov
Nti-Kahla GMBH, Rotary Dental InstrumentsKAHLA Thuringia, GermanyManufacturer, Repackager or relabeler0000api.fda.gov
Oco BiomedicalAlbuquerque, NM, United StatesManufacturer, Repackager or relabeler0000api.fda.gov
Orchid UniqueBridgeport, MI, United StatesContract manufacturer0000api.fda.gov
Osseo Scientific, LLCDover Township, NJ, United StatesRepackager or relabeler, Specification developer0000api.fda.gov
Osstem Implant Co., Ltd.Gangseo-gu Seoul, South KoreaSpecification developer0000api.fda.gov
Osstem Implant Co., Ltd.Haeundae-gu Busan, South KoreaManufacturer0000api.fda.gov
Ossvis Co., Ltd.Anyang-si Gyeonggi, South KoreaManufacturer0000api.fda.gov
Osung MND Co., Ltd.Gimpo-si Gyeonggi, South KoreaManufacturer0000api.fda.gov
Overfibers S.R.LIMOLA Bologna, ItalyComplaint file establishment, Manufacturer0000api.fda.gov
Paltop Advanced Dental Solutions LtdCaesarea Central, IsraelManufacturer, Specification developer0000api.fda.gov
POINTIMPLANT Co., LtdBusan, South KoreaComplaint file establishment, Manufacturer0000api.fda.gov
Produits Dentaires SAVEVEY (SUISSE) Vaud, SwitzerlandManufacturer0000api.fda.gov
Puracon GMBHRosenheim Bavaria, GermanyContract manufacturer0000api.fda.gov
Power Dental USA, Inc.McHenry, IL, United StatesRemanufacturer, Repackager or relabeler0000api.fda.gov
Recherches Techniques Dentaires (R.T.D.)ST. EGREVE Isere, FranceManufacturer, Specification developer0000api.fda.gov
Rhein 83 SRLBOLOGNA Emilia-Romagna, ItalyComplaint file establishment, Manufacturer0000api.fda.gov
Ronvig Dental MFG. A/SDAUGAARD Midtjylland, DenmarkManufacturer0000api.fda.gov
Ritter Implants GmbH & Co. KGBiberach Baden-Wurttemberg, GermanyManufacturer0000api.fda.gov
S.G.S. International LtdBudapest, HungaryManufacturer0000api.fda.gov
Sentronic International Corp.Taipei, TaiwanManufacturer0000api.fda.gov
Sewon Medix, Inc.Busan, South KoreaManufacturer0000api.fda.gov
Shenzhen Dazhou Medical Technology Co., Ltd.Shenzhen Guangdong, ChinaManufacturer0000api.fda.gov
Shenzhen Denco Medical Co., Ltd.Shenzhen 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
Shurcon Manufacturing CompanyJia Shan Zhejiang, ChinaManufacturer0000api.fda.gov
SKY DENT Corp for dental tradingNew York, NY, United StatesManufacturer, Repackager or relabeler0000api.fda.gov
Snucone Co., Ltd.Dalseo-gu Daegu, South KoreaManufacturer0000api.fda.gov
Sphinx Tools LtdDerendingen Solothurn, SwitzerlandContract manufacturer0000api.fda.gov
SurgicraftsSialkot Punjab, PakistanManufacturer0000api.fda.gov
Surgikor, LLCLos Angeles, CA, United StatesSpecification developer0000api.fda.gov
Sweden & Martina S.P.A.Due Carrare Padova, ItalyManufacturer0000api.fda.gov
Symmetry Medical Polyvac SASWAMBRECHIES Nord, FranceContract manufacturer0000api.fda.gov
Shanghai Toboom Dental Techonology CO., LTD.Shanghai, ChinaContract manufacturer, Exporter to the US, Foreign private label distributor, Manufacturer, Remanufacturer, Repackager or relabeler0000api.fda.gov
Shinhung MST Co., Ltd.Wonju Si Gangwon, South KoreaManufacturer0000api.fda.gov
Solventum Germany GmbHSEEFELD Bavaria, GermanyComplaint file establishment, Specification developer0000api.fda.gov
T.A.G. Medical Products Corporation LtdGAATON Northern, IsraelManufacturer0000api.fda.gov
TF New Material Sci And Tec Co.,ltdHuainan Anhui, ChinaManufacturer0000api.fda.gov
Tontarra Medizintechnik GMBHWURMLINGEN Baden-Wurttemberg, GermanyContract manufacturer0000api.fda.gov
Tulsa Dental Products LLCJohnson City, TN, United StatesManufacturer, Repackager or relabeler0000api.fda.gov
TruAbutment Korea Co., Ltd.Bucheon-si Gyeonggi, South KoreaManufacturer0000api.fda.gov
Uniqa Dental LtdNetanya Central, IsraelManufacturer0000api.fda.gov
United Dental ChangzhouChangzhou Jiangsu, ChinaExporter to the US, Manufacturer0000api.fda.gov
Veridiam, LLCOceanside, CA, United StatesContract manufacturer0000api.fda.gov
WARANTEC Co., Ltd.Seongnam-si Gyeonggi, South KoreaManufacturer0000api.fda.gov
Win Wings Corp.SIALKOT Punjab, PakistanManufacturer0000api.fda.gov
Zonefly Medical Devices Co., Ltd.Danyang Jiangsu, ChinaExporter to the US, Manufacturer0000api.fda.gov
Zuga Medical, Inc.Cleveland, OH, United StatesManufacturer0000api.fda.gov

Updated June 25, 1999. 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.