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Data / Medical devices / Syringe, Restorative And Impression Material

Syringe, Restorative And Impression Material (EID): 111 FDA-registered makers in 16 countries

111 establishments in 16 countries are registered with the FDA to make Syringe, Restorative And Impression Material (product code EID, Class 1, 21 CFR 872.4565). 3 of them have a 510(k) clearance or PMA approval on file and 1 has a recall event. The FDA has issued 13 510(k) clearances under this code, the latest on July 12, 1994, and lists 1 recall event (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
EID
Device class
1
Regulation
872.4565
Medical specialty
Dental

Makers by country

CountryMakers
China44
United States27
Germany8
Pakistan6
South Korea6
Japan3
Italy3
Taiwan3
Switzerland3
Hong Kong2
Canada1
Belgium1
Malaysia1
Liechtenstein1
Mexico1
Sweden1

Makers of Syringe, Restorative And Impression Material

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 LLCMilford, DE, United StatesManufacturer, Repackager or relabeler1September 16, 1987000api.fda.gov
GC America Inc.Alsip, IL, United StatesComplaint file establishment, Manufacturer, Repackager or relabeler1October 6, 1981000api.fda.gov
GC Corp.ITABASHI-KU Tokyo, JapanManufacturer, Repackager or relabeler1October 6, 1981000api.fda.gov
Acme Commercial Ways Ltd.Sialkot Punjab, PakistanManufacturer0000api.fda.gov
Amedcon Medical Technology (shenzhen) Co., Ltd.Shenzhen Guangdong, ChinaManufacturer0000api.fda.gov
Anqing Clean Dental Instrument Technology Co.,ltdAnqing City Anhui, ChinaExporter to the US, Manufacturer0000api.fda.gov
Asa Dental S.P.A.MARLIA Lucca, ItalyManufacturer0000api.fda.gov
Anhui Chuangnuo Medical equipment Co., LTDAnqing City Anhui, ChinaExporter to the US, Manufacturer0000api.fda.gov
Beyes Dental IncToronto Ontario, CanadaManufacturer0000api.fda.gov
BGSS Company Asia LimitedZhabei Shanghai, ChinaExporter to the US, Manufacturer0000api.fda.gov
Bisco, Inc.Schaumburg, IL, United StatesRepackager or relabeler, Specification developer0000api.fda.gov
Bausch & Lomb IncorporatedManchester, MO, United StatesManufacturer0000api.fda.gov
Cangzhou Lankang Medical Instruments Developing Co., Ltd.Cangzhou Hebei, ChinaExporter to the US, Manufacturer0000api.fda.gov
CDM Center Of Excellence Ltd.Beijing, ChinaManufacturer0000api.fda.gov
Centrix, Inc.Shelton, CT, United StatesContract manufacturer, Manufacturer, Repackager or relabeler0000api.fda.gov
Chemoment Materials Co.,ltdHefei Anhui, ChinaExporter to the US, Manufacturer0000api.fda.gov
Chi Feng Co.,ltdNew Taipei City, TaiwanContract manufacturer0000api.fda.gov
Collagen Matrix, Inc.Oakland, NJ, United StatesManufacturer0000api.fda.gov
Coltene/Whaledent AGALTSTAETTEN Sankt Gallen, SwitzerlandManufacturer0000api.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
Dent4you AGHeerbrugg Sankt Gallen, SwitzerlandSpecification developer0000api.fda.gov
Dentalmaster (xiamen) Medical Technology Co., Ltd.Xiamen Fujian, ChinaManufacturer0000api.fda.gov
Detax GMBHETTLINGEN Baden-Wurttemberg, GermanyManufacturer, Repackager or relabeler0000api.fda.gov
DMG Chemisch Pharmazeutische Fabrik GMBHHamburg, GermanyManufacturer0000api.fda.gov
Dongguan Wanjin Industrial Co., LtdDongGuang Guangdong, ChinaManufacturer0000api.fda.gov
Dreve Dentamid GMBHUNNA North Rhine-Westphalia, GermanyManufacturer0000api.fda.gov
DXM Co., Ltd.Jeonnam-Gwangju Special Metropolitan City, South KoreaContract manufacturer, Manufacturer0000api.fda.gov
Elite Dental LabHuizhou City Guangdong, ChinaManufacturer0000api.fda.gov
Exelint International, Co.Redondo Beach, CA, United StatesManufacturer, Specification developer0000api.fda.gov
Falcon Surgical Co. (Pvt.) Ltd.Sialkot Punjab, PakistanManufacturer0000api.fda.gov
GC Europe N.V.LEUVEN Vlaams Brabant, BelgiumManufacturer0000api.fda.gov
Greatcare 4u Sdn BhdSelangor Darul Ehsan, MalaysiaManufacturer0000api.fda.gov
Gulmag InternationalSIALKOT Punjab, PakistanManufacturer0000api.fda.gov
Harf IndustriesSIALKOT Punjab, PakistanManufacturer0000api.fda.gov
Hefei Jingcheng Plastic Products Co. LtdHefei Anhui, ChinaManufacturer0000api.fda.gov
Hefei Mlush Sanitary Products Co.,ltdHefei Anhui, ChinaManufacturer0000api.fda.gov
Helmut Zepf Medizintechnik GMBHSEITINGEN Baden-Wurttemberg, GermanyManufacturer0000api.fda.gov
Henan Baistra Medical Devices LimitedZhengzhou Henan, ChinaExporter to the US, Manufacturer0000api.fda.gov
Huanghua DK Dental Co., LtdHuangHua Hebei, ChinaManufacturer0000api.fda.gov
Huanghua Promisee Dental Co., LtdHuanghua Hebei, ChinaManufacturer0000api.fda.gov
Hubei Guarddent Medical Technology Co.,ltdWuhan Hubei, ChinaExporter to the US, Manufacturer0000api.fda.gov
Hefei Xingcheng Sanitary Products CO.,LTDHefei Anhui, ChinaContract manufacturer, Exporter to the US, Manufacturer0000api.fda.gov
Inter-Med, Inc.Racine, WI, United StatesSpecification developer0000api.fda.gov
Ivoclar Vivadent AGSchaan, LiechtensteinSpecification developer0000api.fda.gov
Integra LifeSciences Production CorporationMansfield, MA, United StatesSpecification developer0000api.fda.gov
Jiangsu Caina Medical Co., LtdJiangyin Jiangsu, ChinaManufacturer0000api.fda.gov
Jiangxi Ushine Bright Medical Co., Ltd.Jiujiang City Jiangxi, ChinaContract manufacturer, Exporter to the US, Manufacturer0000api.fda.gov
Kulzer GMBHHANAU Hesse, GermanyManufacturer, Repackager or relabeler0000api.fda.gov
Kuraray Noritake Dental Niigata PlantTAINAI Niigata, JapanManufacturer0000api.fda.gov
Kerr CorporationPomona, CA, United StatesManufacturer0000api.fda.gov
La.sc.od. SPAFLORENCE, TUSCANY Firenze, ItalyManufacturer0000api.fda.gov
Lacigrus InternationalSialkot Punjab, PakistanManufacturer0000api.fda.gov
Lakong Medical Devices Co., Ltd.Dongguan Guangdong, ChinaManufacturer0000api.fda.gov
LLRN Personal Care (shenzhen) Co.,ltdshenzhen Guangdong, ChinaExporter to the US, Manufacturer0000api.fda.gov
Medcave Private LimitedSialkot Punjab, PakistanManufacturer0000api.fda.gov
Mediclus Co., LtdCheongju-si Chungbuk, South KoreaManufacturer0000api.fda.gov
Monitex Industrial Co., Ltd.SAN-CHUNG CITY Taipei, TaiwanManufacturer0000api.fda.gov
Nanchang White Technology Co., Ltd.Nanchang Jiangxi, ChinaContract manufacturer, Exporter to the US, Manufacturer0000api.fda.gov
Nanova Biomaterials IncColumbia, MO, United StatesComplaint file establishment, Repackager or relabeler, Specification developer0000api.fda.gov
Novabone Products, LLCAlachua, FL, United StatesManufacturer0000api.fda.gov
Osstem Implant Co., Ltd.Gangseo-gu Seoul, South KoreaSpecification developer0000api.fda.gov
Osstem Implant Co., Ltd.SIHEUNG Gyeonggi, South KoreaManufacturer0000api.fda.gov
Pacific Care Limited / Pacificare Asia LimitedHong Kong, Hong KongManufacturer0000api.fda.gov
Pilotis Tech LLCBrookhaven, GA, United StatesComplaint file establishment, Specification developer0000api.fda.gov
Plasdent Shanghai Co., Ltd.Shanghai, ChinaManufacturer0000api.fda.gov
Practicon, Inc.Greenville, NC, United StatesManufacturer, Repackager or relabeler, Specification developer0000api.fda.gov
Premier Dental Products Co.Plymouth Meeting, PA, United StatesComplaint file establishment, Repackager or relabeler, Specification developer0000api.fda.gov
Premium Plus (dongguan) LimitedDongguan Guangdong, ChinaManufacturer0000api.fda.gov
Pulpdent CorporationWatertown, MA, United StatesManufacturer0000api.fda.gov
Power Dental USA, Inc.McHenry, IL, United StatesManufacturer, Remanufacturer, Repackager or relabeler0000api.fda.gov
Premium Plus International LimitedHong Kong, Hong KongManufacturer0000api.fda.gov
Ready Set ImportBeverly Hills, CA, United StatesSpecification developer0000api.fda.gov
Scientific Pharmaceuticals, Inc.Pomona, CA, United StatesContract manufacturer, Manufacturer0000api.fda.gov
SDS de Mexico S. de R.L. de C.V.MEXICALI, B.C. C.P. Baja California, MexicoContract manufacturer0000api.fda.gov
Seilglobal Co., LtdBusan Gyeongnam, South KoreaManufacturer0000api.fda.gov
Shanghai Bing Fan Industrial Co.,ltd.Shanghai, ChinaContract manufacturer, Exporter to the US, Manufacturer0000api.fda.gov
Shanghai Kangqiao Dental Instruments FactoryShanghai, ChinaExporter to the US, Manufacturer0000api.fda.gov
Shanghai Kindly Enterprise Development Group Co., Ltd.JIADING Shanghai, ChinaManufacturer0000api.fda.gov
Shanghai Lions Industrial Co.,ltd.Shanghai, ChinaContract manufacturer, Exporter to the US0000api.fda.gov
Shengiho Enterprise Co., Ltd.Taichung City, TaiwanManufacturer0000api.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
Sherpa KoreaSaha-gu Busan, South KoreaManufacturer0000api.fda.gov
Sino-Vista Dental Instruments Co., Ltd.Zibo Shandong, ChinaContract manufacturer0000api.fda.gov
Solventum Us LLCEagan, MN, United StatesComplaint file establishment, Specification developer0000api.fda.gov
STS CorporationDuluth, GA, United StatesComplaint file establishment, Repackager or relabeler, Specification developer0000api.fda.gov
Svenska Dentorama ABSOLLENTUNA Stockholm, SwedenManufacturer0000api.fda.gov
Shandong Huge Dental Material CorporationRizhao Shandong, ChinaManufacturer0000api.fda.gov
Shanghai Jolly Industrial Co., Ltd.Shanghai, ChinaContract manufacturer, Exporter to the US0000api.fda.gov
Solventum Germany GmbHSEEFELD Bavaria, GermanyManufacturer, Specification developer0000api.fda.gov
Solventum Orthodontics CorporationMonrovia, CA, United StatesComplaint file establishment, Specification developer0000api.fda.gov
Solventum US LLCSan Antonio, TX, United StatesComplaint file establishment, Specification developer0000api.fda.gov
Suzhou Pac-Dent Technology Co., LtdSUZHOU CITY Jiangsu, ChinaContract manufacturer0000api.fda.gov
TF New Material Sci And Tec Co.,ltdHuainan Anhui, ChinaManufacturer0000api.fda.gov
Tianjin Water Source Tech Co., Ltd.Tianjin, ChinaManufacturer0000api.fda.gov
TOKUYAMA DENTAL CORPORATION Kashima FactoryKamisu-shi Ibaraki, 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
Ustomed Instrumente GMBH & Co. KGTuttlingen Baden-Wurttemberg, GermanyManufacturer0000api.fda.gov
Ultradent Products Inc.South Jordan, UT, United StatesContract manufacturer, Manufacturer0010api.fda.gov
Vastmed LLCGrand Prairie, TX, United StatesSpecification developer0000api.fda.gov
Wuxi Yushou Medical Appliances Co., LtdWuxi City Jiangsu, ChinaContract manufacturer0000api.fda.gov
Xiantao S&J Protective Products Co., LtdXiantao Hubei, ChinaExporter to the US, Manufacturer0000api.fda.gov
Young Microbrush LLCGrafton, WI, United StatesContract manufacturer, Repackager or relabeler0000api.fda.gov
Zhejiang Jasmine Oralcare Products Co., Ltd.Jiaxing Zhejiang, ChinaContract manufacturer, Exporter to the US, Manufacturer0000api.fda.gov
Zhejiang Yamei Medical Equipment Technology Co., Ltd.Yang Jiao Lang Zin'an Town Zhejiang, ChinaManufacturer0000api.fda.gov
Zhermack S.P.A.BADIA POLESINE (RO) Rovigo, ItalyManufacturer, Specification developer0000api.fda.gov
ZOGEAR Medical Co., Ltd.Yizheng Jiangsu, ChinaManufacturer0000api.fda.gov
medmix China LTDShanghai, ChinaContract manufacturer0000api.fda.gov
medmix Deutschland GmbHKiel Schleswig-Holstein, GermanyContract manufacturer0000api.fda.gov
medmix Switzerland AGHaag Sankt Gallen, SwitzerlandContract manufacturer0000api.fda.gov

Updated July 12, 1994. 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.