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Data / Medical devices / Retainer, Matrix

Retainer, Matrix (JEP): 80 FDA-registered makers in 16 countries

80 establishments in 16 countries are registered with the FDA to make Retainer, Matrix (product code JEP, Class 1, 21 CFR 872.4565). 0 of them have a 510(k) clearance or PMA approval on file and 0 have a recall event. The FDA has issued 3 510(k) clearances under this code, the latest on August 17, 2009, 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
JEP
Device class
1
Regulation
872.4565
Medical specialty
Dental

Makers by country

CountryMakers
Pakistan23
United States20
China11
Germany8
Canada2
South Korea2
Sweden2
Mexico2
Switzerland2
Hong Kong2
Brazil1
Japan1
Denmark1
Italy1
India1
United Kingdom1

Makers of Retainer, Matrix

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, BrazilManufacturer0000api.fda.gov
A. Schweickhardt GMBH & Co. KGSeitingen-Oberflacht Baden-Wurttemberg, GermanyManufacturer, Repackager or relabeler0000api.fda.gov
Acheron Instruments (pvt.) Ltd.LAHORE Punjab, PakistanManufacturer0000api.fda.gov
Acme Commercial Ways Ltd.Sialkot Punjab, PakistanManufacturer0000api.fda.gov
Acme EnterprisesSialkot Punjab, PakistanManufacturer0000api.fda.gov
Aesculap AGTUTTLINGEN, DONAU Baden-Wurttemberg, GermanyManufacturer0000api.fda.gov
ALVI ExpoSialkot Punjab, PakistanManufacturer0000api.fda.gov
AMD Medicom Inc.Pointe-Claire, Montreal Quebec, CanadaComplaint file establishment, Exporter to the US, Specification developer0000api.fda.gov
Aspen Surgical Products, Inc.Caledonia, MI, United StatesComplaint file establishment, Specification developer0000api.fda.gov
Astar Orthodontics Inc.Shanghai, ChinaManufacturer0000api.fda.gov
ATRIA Co.Seoul, South KoreaManufacturer0000api.fda.gov
B. Ali ImpexSIALKOT, Punjab, PakistanManufacturer0000api.fda.gov
Bashir Jamil & Brothers (pvt.), Ltd.Sialkot Punjab, PakistanManufacturer0000api.fda.gov
Bioclear Matrix Systems, LLCTacoma, WA, United StatesRepackager or relabeler, Specification developer0000api.fda.gov
Cangzhou Lankang Medical Instruments Developing Co., Ltd.Cangzhou Hebei, ChinaExporter to the US, Manufacturer0000api.fda.gov
Central Surgical Co. Pvt. Ltd.Sialkot Punjab, PakistanManufacturer0000api.fda.gov
Commic SurgicoSIALKOT Punjab, PakistanManufacturer0000api.fda.gov
Daddy D ProSialkot Punjab, PakistanManufacturer0000api.fda.gov
Denovo Dental IncBaldwin Park, CA, United StatesManufacturer0000api.fda.gov
Dental StudioAnyang-si Gyeonggi, South KoreaManufacturer0000api.fda.gov
Dentatus ABSPANGA Stockholm, SwedenManufacturer0000api.fda.gov
Dentech Corp.Tokyo, JapanContract manufacturer, Manufacturer0000api.fda.gov
Devemed GMBHNEUHAUSEN OB ECK Baden-Wurttemberg, GermanyContract manufacturer, Manufacturer0000api.fda.gov
Directa ABUPPLANDS VAESBY Stockholm, SwedenManufacturer0000api.fda.gov
Dockum Research LabIrwindale, CA, United StatesManufacturer, Repackager or relabeler0000api.fda.gov
DSC Dental, LLCSaint George, UT, United StatesManufacturer0000api.fda.gov
E. Hahnenkratt GMBHKOENIGSBACH-STEIN Baden-Wurttemberg, GermanyManufacturer0000api.fda.gov
Ergodenta ApsTaastrup Hovedstaden, DenmarkContract manufacturer, Manufacturer, Repackager or relabeler0000api.fda.gov
Falcon Surgical Co. (Pvt.) Ltd.Sialkot Punjab, PakistanManufacturer0000api.fda.gov
Garrison Dental SolutionsSpring Lake, MI, United StatesComplaint file establishment, Manufacturer, Specification developer0000api.fda.gov
Gulmag InternationalSIALKOT Punjab, PakistanManufacturer0000api.fda.gov
GoldenDentRoseville, MI, United StatesRepackager or relabeler, Specification developer0000api.fda.gov
Harf IndustriesSIALKOT Punjab, PakistanManufacturer0000api.fda.gov
Helmut Zepf Medizintechnik GMBHSEITINGEN Baden-Wurttemberg, GermanyManufacturer0000api.fda.gov
Hubei Guarddent Medical Technology Co.,ltdWuhan Hubei, ChinaExporter to the US, Manufacturer0000api.fda.gov
Inventex MedicalNiles, IL, United StatesContract manufacturer0000api.fda.gov
Industrias Apson S.A de C.VAGUA PRIETA Sonora, MexicoContract manufacturer0000api.fda.gov
Kerr CorporationPomona, CA, United StatesSpecification developer0000api.fda.gov
Kerr Italia, S.r.l.SCAFATI Salerno, ItalyManufacturer0000api.fda.gov
Laparomed Private LimitedMumbai Maharashtra, IndiaManufacturer0000api.fda.gov
Lohar Medical CompanySialkot Punjab, PakistanManufacturer0000api.fda.gov
La Maison Dentaire / Medirel SAAgno Ticino, SwitzerlandManufacturer0000api.fda.gov
Medical Devices Group LimitedN.T., Hong KongContract manufacturer0000api.fda.gov
Medisporex (pvt) Ltd.SIALKOT Punjab, PakistanContract manufacturer, Manufacturer0000api.fda.gov
Nopa Instruments, Medizintechnik GMBHTUTTLINGEN Baden-Wurttemberg, GermanyContract manufacturer0000api.fda.gov
Nova Biomedical CorporationWaltham, MA, United StatesComplaint file establishment, Manufacturer0000api.fda.gov
Nova Biomedical CorporationBillerica, MA, United StatesManufacturer, Remanufacturer0000api.fda.gov
Nova InstrumentsBerkshire Wokingham, United KingdomContract manufacturer, Exporter to the US, Manufacturer0000api.fda.gov
Onvet Medical Canada IncTORONTO Ontario, CanadaManufacturer0000api.fda.gov
Pacific Care Limited / Pacificare Asia LimitedHong Kong, Hong KongContract manufacturer0000api.fda.gov
Panorama International.SIALKOT Punjab, PakistanManufacturer0000api.fda.gov
Pilotis Tech LLCBrookhaven, GA, United StatesComplaint file establishment, Specification developer0000api.fda.gov
Pomee CorporationSialkot Punjab, PakistanManufacturer0000api.fda.gov
Practicon, Inc.Greenville, NC, United StatesSpecification developer0000api.fda.gov
Premier Dental Products Co.Plymouth Meeting, PA, United StatesComplaint file establishment, Repackager or relabeler, Specification developer0000api.fda.gov
Produits Dentaires SAVEVEY (SUISSE) Vaud, SwitzerlandManufacturer0000api.fda.gov
Pulpdent CorporationWatertown, MA, United StatesManufacturer, Repackager or relabeler0000api.fda.gov
Power Dental USA, Inc.McHenry, IL, United StatesRemanufacturer, Repackager or relabeler0000api.fda.gov
Richbolt EnterprisesSIALKOT Punjab, PakistanManufacturer0000api.fda.gov
Shanghai Kangqiao Dental Instruments FactoryShanghai, ChinaExporter to the US, Manufacturer0000api.fda.gov
Shanghai Lions Industrial Co.,ltd.Shanghai, ChinaContract manufacturer, Exporter to the US0000api.fda.gov
Shanghai Medical Instruments (group) Ltd. Corp.Shanghai, ChinaManufacturer0000api.fda.gov
Shenzhen Topinnor Technology Co.,ltdShenzhen Guangdong, ChinaManufacturer0000api.fda.gov
Signor Seven InternationalSialkot Punjab, PakistanManufacturer0000api.fda.gov
Silver Plus Corp.SIALKOT Punjab, PakistanManufacturer0000api.fda.gov
SurgicraftsSialkot Punjab, PakistanManufacturer0000api.fda.gov
SurjexSIALKOT Punjab, PakistanManufacturer0000api.fda.gov
Shanghai Jolly Industrial Co., Ltd.Shanghai, ChinaContract manufacturer, Exporter to the US0000api.fda.gov
Suzhou Pac-Dent Technology Co., LtdSUZHOU CITY Jiangsu, ChinaContract manufacturer0000api.fda.gov
Tekno Medical Optik-Chirurgie GMBHTUTTLINGEN-Nendingen Baden-Wurttemberg, GermanyManufacturer, Repackager or relabeler0000api.fda.gov
Tessy Plastics Shanghai Co., LtdShanghai, ChinaContract manufacturer0000api.fda.gov
Towne Brothers (pvt.), Ltd.SIALKOT Punjab, PakistanManufacturer0000api.fda.gov
Ustomed Instrumente GMBH & Co. KGTuttlingen Baden-Wurttemberg, GermanyManufacturer0000api.fda.gov
Ultradent Products Inc.South Jordan, UT, United StatesManufacturer, Repackager or relabeler0000api.fda.gov
Vago International Manufacturing SA De CVMonterrey Nuevo Leon, MexicoContract manufacturer0000api.fda.gov
White Bite, Inc.Parrish, FL, United StatesSpecification developer0000api.fda.gov
Young Innovations Inc.Algonquin, IL, United StatesSpecification developer0000api.fda.gov
Zain's Medical ImageSIALKOT Punjab, PakistanManufacturer0000api.fda.gov
Zirc Dental Products, Inc.Buffalo, MN, United StatesComplaint file establishment, Manufacturer0000api.fda.gov
iBrite Suzhou Technology Co., LtdSUZHOU CITY Jiangsu, ChinaContract manufacturer0000api.fda.gov

Updated August 17, 2009. 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.