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Biomaterials Korea Inc.: FDA-registered device maker in Hanam-si Gyeonggi, South Korea, 5 510(k) clearances

Biomaterials Korea Inc. is registered with the FDA (registration 3005515228) in Hanam-si Gyeonggi, South Korea. It lists 17 device types. The FDA files 5 510(k) clearances under its listings, the newest dated August 21, 2023. Registered through 2027. 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.

Get makers like this oneWatch Biomaterials Korea Inc.
FDA registration number
3005515228
Address
#413 #329 #, Jojeong-daero, Hanam-si Gyeonggi, South Korea, 0
Owner or operator
BIOMATERIALS KOREA INC. (9080640)
Roles
Exporter to the US, Manufacturer
First device listed
December 15, 2005
Registered through
2027
Brand names listed
4054, 4191, 4309, 4433, 4668, 4670, 4809, 4815 and more

Devices it lists

DeviceProduct codeClassRoleSource
Accessories, Implant, Dental, EndosseousNDP1Manufactureraccessdata.fda.gov
Band, Material, OrthodonticDYO1Manufactureraccessdata.fda.gov
Bur, DentalEJL1Manufactureraccessdata.fda.gov
Clamp, Wire, OrthodonticECN1Manufactureraccessdata.fda.gov
Driver, Band, OrthodonticECT1Exporter to the USaccessdata.fda.gov
Forceps, Rongeur, SurgicalEMH1Exporter to the US, Manufactureraccessdata.fda.gov
Handle, Instrument, DentalEJB1Manufactureraccessdata.fda.gov
Implant, Endosseous, OrthodonticOAT2Manufactureraccessdata.fda.gov
Instrument, Cutting, OperativeEKD1Manufactureraccessdata.fda.gov
Plate, BoneJEY2Manufactureraccessdata.fda.gov
Pliers, OperativeEJY1Exporter to the USaccessdata.fda.gov
Positioner, Tooth, PreformedKMY1Manufactureraccessdata.fda.gov
Probe, PeriodonticEIX1Exporter to the USaccessdata.fda.gov
Retainer, Screw Expansion, OrthodonticDYJ1Manufactureraccessdata.fda.gov
Scissors, Surgical Tissue, DentalEGN1Exporter to the US, Manufactureraccessdata.fda.gov
Spring, OrthodonticECO1Manufactureraccessdata.fda.gov
Wire, OrthodonticDZC1Manufactureraccessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided510(k) numberDeviceProduct codeDecisionApplicantSource
August 21, 2023K222245ACR Screw SystemOATSubstantially EquivalentBiomaterials Korea, Inc.accessdata.fda.gov
August 30, 2018K173623Anchor plateOATSubstantially EquivalentBiomaterials Korea, Inc.accessdata.fda.gov
December 8, 2011K110926BONE PLATE; BONE SCREWJEYSubstantially EquivalentBiomaterials Korea, Inc.accessdata.fda.gov
September 26, 2011K111809SL TYPE ORTHODONTIC ANCHOR SCREWS, SPL TYPE ORTHODONTIC ANCHOR SCREWSOATSubstantially EquivalentBiomaterials Korea, Inc.accessdata.fda.gov
July 26, 2007K063495C TYPE, CT TYPE, AND SPECIAL TYPE ORTHODONTIC ANCHOR SCREWSOATSubstantially EquivalentBiomaterials Korea, Inc.accessdata.fda.gov

Compare with other makers

Updated August 21, 2023. 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.