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Data / Medical devices / Needle, Dental

Needle, Dental (DZM): 105 FDA-registered makers in 13 countries

105 establishments in 13 countries are registered with the FDA to make Needle, Dental (product code DZM, Class 1, 21 CFR 872.4730). 4 of them have a 510(k) clearance or PMA approval on file and 0 have a recall event. The FDA has issued 16 510(k) clearances under this code, the latest on April 27, 1999, 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
DZM
Device class
1
Regulation
872.4730
Medical specialty
Dental

Makers by country

CountryMakers
China49
United States15
South Korea11
Pakistan10
Japan5
Germany4
France3
India2
Italy2
United Kingdom1
Poland1
Vietnam1
Mexico1

Makers of Needle, 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
Dentsply LLCYork, PA, United StatesSpecification developer1April 28, 1992000api.fda.gov
Exelint International, Co.Redondo Beach, CA, United StatesManufacturer, Specification developer1April 11, 1986000api.fda.gov
FAIRFAX MEDICAL PRODUCTS LtdLondon London, City of, United KingdomManufacturer1June 3, 1991000api.fda.gov
Tulsa Dental Products LLCJohnson City, TN, United StatesManufacturer1April 27, 1999000api.fda.gov
3D Dental Desings And DevelopmentShaker Heights, OH, United StatesContract manufacturer0000api.fda.gov
Aesculap AGTUTTLINGEN, DONAU Baden-Wurttemberg, GermanyComplaint file establishment, Manufacturer0000api.fda.gov
Air Water Realize Inc.IWAKI-SHI Fukushima, JapanContract manufacturer0000api.fda.gov
Air Water Realize Inc.Kasama-shi Ibaraki, JapanContract manufacturer, Exporter to the US0000api.fda.gov
Anhui Kangda Medical Products Co., Ltd.Tianchang City Anhui, ChinaManufacturer0000api.fda.gov
Anji Spenq Industrial Co., Ltd.Huzhou Zhejiang, ChinaExporter to the US, Manufacturer0000api.fda.gov
AnthogyrSALLANCHES Haute-Savoie, FranceManufacturer0000api.fda.gov
B&L Biotech Co., IncAnsan City Gyeonggi, South KoreaManufacturer0000api.fda.gov
Beijing C-Root Dental Medical Devices Co., Ltd.Beijing, ChinaManufacturer0000api.fda.gov
BGSS Company Asia LimitedZhabei Shanghai, ChinaExporter to the US, Manufacturer0000api.fda.gov
BH Medical Products Co., LtdChangzhou City Jiangsu, ChinaContract manufacturer, Manufacturer0000api.fda.gov
Boen Healthcare Co., Ltd.Suzhou Jiangsu, ChinaExporter to the US, Specification developer0000api.fda.gov
Brasseler U.S.A. Dental, LLCSavannah, GA, United StatesRepackager or relabeler, Specification developer0000api.fda.gov
Berpu Medical Technology Co., Ltd.WENZHOU Zhejiang, ChinaManufacturer0000api.fda.gov
Biopsy Fine Cut InstrumentsSialkot Punjab, PakistanManufacturer0000api.fda.gov
C-K Dental Ind. Co., Ltd.Bucheon-Si, Gyeonggi-Do, South KoreaManufacturer0000api.fda.gov
CDM Center Of Excellence Ltd.Beijing, ChinaManufacturer0000api.fda.gov
China Zhong Yan Chang Xing International Co. LtdZibo City Shandong, ChinaContract manufacturer0000api.fda.gov
Coltene/Whaledent Inc.Cuyahoga Falls, OH, United StatesManufacturer0000api.fda.gov
Comfort Surgical InstrumentsSialkot Punjab, PakistanManufacturer0000api.fda.gov
Cardinal HealthHazelwood, MO, United StatesSpecification developer0000api.fda.gov
Cardinal HealthDeland, FL, United StatesManufacturer0000api.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 Products LabSeattle, WA, United StatesManufacturer0000api.fda.gov
Dental StudioAnyang-si Gyeonggi, South KoreaManufacturer0000api.fda.gov
Endo Tech InstrumentsSialkot Punjab, PakistanManufacturer0000api.fda.gov
Foshan Gladent Medical Instrument Co.,ltd.Foshan Guangdong, ChinaExporter to the US, Manufacturer0000api.fda.gov
Fabryka Narzedzi Medycznych CHIRMED Marcin Dyner Spolka KomandytowaRUDNIKI K/CZESTOCHOWY Slaskie, PolandManufacturer0000api.fda.gov
Falcon Surgical Co. (Pvt.) Ltd.Sialkot Punjab, PakistanManufacturer0000api.fda.gov
Foshan CICADA Dental Instrument Co., Ltd.Foshan Guangdong, ChinaManufacturer0000api.fda.gov
Garish ApparelsWazirabad Punjab, PakistanManufacturer0000api.fda.gov
Greens Surgicals Private LimitedVadodara Gujarat, IndiaManufacturer0000api.fda.gov
Guilin Woodpecker Medical Instrument Co., LtdGUILIN CITY Guangxi, ChinaManufacturer0000api.fda.gov
GUILIN YIKESHI Medical Device CO LTDGuilin Guangxi, ChinaManufacturer0000api.fda.gov
Hefei Mlush Sanitary Products Co.,ltdHefei Anhui, ChinaManufacturer0000api.fda.gov
Huanghua DK Dental Co., LtdHuangHua Hebei, ChinaManufacturer0000api.fda.gov
Hubei Guarddent Medical Technology Co.,ltdWuhan Hubei, ChinaExporter to the US, Manufacturer0000api.fda.gov
Huzhou Junda Industry Co., Ltd.Anji Zhejiang, ChinaContract manufacturer, Exporter to the US, Manufacturer0000api.fda.gov
Heuer International (A division of GST Corporation Limited)NOIDA Uttar Pradesh, IndiaForeign private label distributor, Manufacturer, Repackager or relabeler0000api.fda.gov
Jiangsu Zhongsheng Medical Technology Co..ltdSUQIAN CITY Jiangsu, ChinaContract manufacturer, Exporter to the US, Manufacturer0000api.fda.gov
Jiangyin Nanquan Macromolecule Product Co., Ltd.JIANGYIN Jiangsu, ChinaManufacturer0000api.fda.gov
Kerr CorporationPomona, CA, United StatesManufacturer0000api.fda.gov
Kohler Medizintechnik GmbHSTOCKACH Baden-Wurttemberg, GermanyContract manufacturer, Manufacturer0000api.fda.gov
Lacigrus InternationalSialkot Punjab, PakistanManufacturer0000api.fda.gov
MaruchiWonju-si Gangwon, South KoreaManufacturer0000api.fda.gov
MctbioYongin-si Gyeonggi, South KoreaManufacturer0000api.fda.gov
Meed Skills SurgicalSIALKOT Punjab, PakistanManufacturer0000api.fda.gov
Neo Dental Chemical Products Co., Ltd.Nagano, JapanExporter to the US, Manufacturer0000api.fda.gov
Ningbo Caremed Medical Products Co LtdNingbo Zhejiang, ChinaContract manufacturer, Manufacturer0000api.fda.gov
Ningbo Greetmed Medical Instruments Co., Ltd.Ningbo Zhejiang, ChinaExporter to the US, Specification developer0000api.fda.gov
Nipro Medical Industries Ltd.TATEBAYASHI-SHI Gunma, JapanContract manufacturer, Manufacturer0000api.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
Pearl Dent Co., Ltd.HOCHIMINH CITY Ho Chi Minh, VietnamContract manufacturer, Manufacturer0000api.fda.gov
Pierrel S.P.A.Capua Caserta, ItalyForeign private label distributor, Specification developer0000api.fda.gov
Plasdent Shanghai Co., Ltd.Shanghai, ChinaManufacturer0000api.fda.gov
Practicon, Inc.Greenville, NC, United StatesSpecification developer0000api.fda.gov
Premium Plus (dongguan) LimitedDongguan Guangdong, ChinaManufacturer0000api.fda.gov
Pulpdent CorporationWatertown, MA, United StatesManufacturer0000api.fda.gov
Ready Set ImportBeverly Hills, CA, United StatesSpecification developer0000api.fda.gov
SDS de Mexico S. de R.L. de C.V.MEXICALI, B.C. C.P. Baja California, MexicoContract manufacturer0000api.fda.gov
SeptodontCEDEX Val-de-Marne, FranceManufacturer0000api.fda.gov
Shandong Caremed Medical Products Co.,ltd.Heze Shandong, ChinaExporter to the US, Manufacturer0000api.fda.gov
Shandong Zhushi Pharmaceutical Group Co., LtdHeze Shandong, ChinaExporter to the US, Manufacturer0000api.fda.gov
Shanghai Alwings Medical Instrument Co.,ltd.Shanghai, ChinaManufacturer0000api.fda.gov
Shanghai Dochem Industries Co., Ltd.Shanghai, ChinaManufacturer0000api.fda.gov
Shanghai Fanta Dental Materials Co., Ltd.Shanghai, ChinaExporter to the US, Manufacturer0000api.fda.gov
Shanghai Lions Industrial Co.,ltd.Shanghai, ChinaContract manufacturer, Exporter to the US0000api.fda.gov
Shenzhen Denco Medical Co., Ltd.Shenzhen Guangdong, ChinaContract manufacturer, Manufacturer0000api.fda.gov
Shenzhen Forever Medical Devices Co., LtdShenzhen Guangdong, ChinaContract manufacturer, Manufacturer0000api.fda.gov
Shenzhen Moye Technology Co LtdShenzhen Guangdong, ChinaManufacturer0000api.fda.gov
Shenzhen Perfect Medical Instruments Co., Ltd.Shenzhen Guangdong, ChinaManufacturer0000api.fda.gov
Shenzhen Rogin Medical Co., Ltdshenzhen Guangdong, ChinaContract manufacturer, Exporter to the US, Manufacturer0000api.fda.gov
Shinhung Co. Ltd.Ansan-si Gyeonggi, South KoreaManufacturer0000api.fda.gov
Skill To Tech InternationalSialkot Punjab, PakistanManufacturer0000api.fda.gov
Smeng Co.,ltd.Busan, South KoreaManufacturer0000api.fda.gov
Sofic SASMazamet, Cedex Tarn, FranceManufacturer0000api.fda.gov
Spident Co., Ltd.INCHEON Gyeonggi, South KoreaManufacturer0000api.fda.gov
Suzhou Ramo Medical Instrument Co., Ltd.Suzhou City Jiangsu, ChinaExporter to the US, Manufacturer0000api.fda.gov
Shanghai Jolly Industrial Co., Ltd.Shanghai, ChinaContract manufacturer, Exporter to the US0000api.fda.gov
Shanghai Joy Crown Industry Co., LtdPu Dong New Area Shanghai, ChinaContract manufacturer0000api.fda.gov
Sungshim Medicare Co.,Ltd.Anseong-si Gyeonggi, South KoreaManufacturer0000api.fda.gov
Suzhou Pac-Dent Technology Co., LtdSUZHOU CITY Jiangsu, ChinaContract manufacturer0000api.fda.gov
Technimen SkillersSIALKOT Punjab, PakistanManufacturer0000api.fda.gov
Tecnofar S.P.A.Delebio Sondrio, ItalyManufacturer0000api.fda.gov
TF New Material Sci And Tec Co.,ltdHuainan Anhui, ChinaManufacturer0000api.fda.gov
Tianjin Water Source Tech Co., Ltd.Tianjin, ChinaManufacturer0000api.fda.gov
Tochigi Seiko Co., LtdTochigi-shi, JapanManufacturer0000api.fda.gov
Tribest Dental Products Co LtdYangzhong Jiangsu, ChinaExporter to the US, Manufacturer0000api.fda.gov
The Belport Company, Inc DBA Gingi-PakCamarillo, CA, United StatesRepackager or relabeler, Specification developer0000api.fda.gov
United Plastics Group(suzhou)co.,ltdSuzhou Jiangsu, ChinaManufacturer0000api.fda.gov
Ustomed Instrumente GMBH & Co. KGTuttlingen Baden-Wurttemberg, GermanyManufacturer0000api.fda.gov
Wenzhou Aochang Misawa Medical Tech. Co., LtdWenzhou Zhejiang, ChinaManufacturer0000api.fda.gov
Win Wings Corp.SIALKOT Punjab, PakistanManufacturer0000api.fda.gov
Xiantao S&J Protective Products Co., LtdXiantao Hubei, ChinaExporter to the US, Manufacturer0000api.fda.gov
Xinhua Surgical Instrument Co. Ltd.ZIBO Shandong, ChinaManufacturer0000api.fda.gov
Xlent Global IncLas Vegas, NV, United StatesSpecification developer0000api.fda.gov
Zhejiang Lidesen Medical Instrument Co., LtdHangzhou Zhejiang, ChinaExporter to the US, Manufacturer0000api.fda.gov
ZOGEAR Medical Co., Ltd.Yizheng Jiangsu, ChinaManufacturer0000api.fda.gov
iBrite Suzhou Technology Co., LtdSUZHOU CITY Jiangsu, ChinaContract manufacturer0000api.fda.gov
medmix Deutschland GmbHKiel Schleswig-Holstein, GermanyContract manufacturer, Manufacturer0000api.fda.gov

Updated April 27, 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.