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Data / Medical devices / Belize / Bina Limited

Bina Limited: FDA-registered device maker in Corozal, Belize, 24 510(k) clearances

Bina Limited is registered with the FDA (registration 3012627824) in Corozal, Belize. It lists 16 device types. The FDA files 24 510(k) clearances under its listings, the newest dated September 18, 2020. Registered through 2026. FDA data exported November 2, 2026.

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Get makers like this oneWatch Bina Limited
FDA registration number
3012627824
Address
Kunal Plaza, Freedom Avenue, Corozal Free Zone, Santa Elena Border, Corozal, Belize, 01
Owner or operator
BINA LIMITED (10052298)
Roles
Exporter to the US
First device listed
December 26, 2017
Registered through
2026
Brand names listed
ABRASIVE, Alloy, amalgam, DENTAL BOND, DENTAL BUR, DENTAL CEMENT, DENTAL FILE, DENTAL HANDLE, DIAMIOND BUR and more

Devices it lists

DeviceProduct codeClassRoleSource
Agent, Polishing, Abrasive, Oral CavityEJR1Exporter to the USaccessdata.fda.gov
Agent, Tooth Bonding, ResinKLE2Exporter to the USaccessdata.fda.gov
Alloy, AmalgamEJJ2Exporter to the USaccessdata.fda.gov
Bur, DentalEJL1Exporter to the USaccessdata.fda.gov
Cement, DentalEMA2Exporter to the USaccessdata.fda.gov
File, Pulp Canal, EndodonticEKS1Exporter to the USaccessdata.fda.gov
Gutta-PerchaEKM1Exporter to the USaccessdata.fda.gov
Handle, Instrument, DentalEJB1Exporter to the USaccessdata.fda.gov
Instrument, Diamond, DentalDZP1Exporter to the USaccessdata.fda.gov
Material, Tooth Shade, ResinEBF2Exporter to the USaccessdata.fda.gov
Point, Paper, EndodonticEKN1Exporter to the USaccessdata.fda.gov
Post, Root CanalELR1Exporter to the USaccessdata.fda.gov
Resin, Root Canal FillingKIF2Exporter to the USaccessdata.fda.gov
Retractor, All TypesEIG1Exporter to the USaccessdata.fda.gov
Sealant, Pit And Fissure, And ConditionerEBC2Exporter to the USaccessdata.fda.gov
Unit, Oral IrrigationEFS1Exporter to the USaccessdata.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
September 18, 2020K200174DIA-ROOT BIO MTAKIFSubstantially EquivalentDiaDent Group Internationalaccessdata.fda.gov
June 25, 2020K200175DIA-ROOT BIO SealerKIFSubstantially EquivalentDiaDent Group Internationalaccessdata.fda.gov
June 3, 2019K182625Diapex PlusKIFSubstantially EquivalentDiaDent Group Internationalaccessdata.fda.gov
June 23, 2015K150696Jade 37% Phosphoric Acid Etchant GelKLESubstantially EquivalentDharma Research, Inc.accessdata.fda.gov
December 8, 2010K102984AURAEBFSubstantially EquivalentSdi Limitedaccessdata.fda.gov
November 15, 2006K062065RIVA LUTING PLUSEMASubstantially EquivalentSouthern Dental Industries, Inc.accessdata.fda.gov
June 15, 2005K051008SETEMASubstantially EquivalentSouthern Dental Industries, Ltd.accessdata.fda.gov
June 3, 2005K050870RIVA LIGHT CUREEMASubstantially EquivalentSouthern Dental Industries, Inc.accessdata.fda.gov
May 27, 2005K050658RESO-PAC PERIODONTAL DRESSINGEMASubstantially EquivalentHager Worldwide, Inc.accessdata.fda.gov
December 7, 2004K042452RIVA SILVEREMASubstantially EquivalentSouthern Dental Industries, Inc.accessdata.fda.gov
April 30, 2004K040393RIVA LUTINGEMASubstantially EquivalentSouthern Dental Industries, Inc.accessdata.fda.gov
April 17, 2003K030516RIVA-SELF CUREEMASubstantially EquivalentSouthern Dental Industries, Inc.accessdata.fda.gov
October 22, 2001K012528ICEEBFSubstantially EquivalentSouthern Dental Industries, Ltd.accessdata.fda.gov
December 8, 1997K973092STAEKLESubstantially EquivalentSouthern Dental Industries, Inc.accessdata.fda.gov
December 8, 1997K973091WAVEEBFSubstantially EquivalentSouthern Dental Industries, Inc.accessdata.fda.gov
January 24, 1996K955285GALLOYEJJSubstantially EquivalentSouthern Dental Industries, Inc.accessdata.fda.gov
July 5, 1994K941899SDI COMPOSTIESEBFSubstantially EquivalentSouthern Dental Industries, Inc.accessdata.fda.gov
June 6, 1994K934192PARAPOST XT SYSTEMELRSubstantially EquivalentColtene/Whaledent, Inc.accessdata.fda.gov
August 14, 1990K896071ULTRA II PORCELAIN POLISHING PASTEEJRSubstantially EquivalentShofu Dental Corp.accessdata.fda.gov
February 13, 1989K885233NOVA DIAMONDDZPSubstantially EquivalentMicrocopy, Div. Neo-Flo, Inc.accessdata.fda.gov
October 30, 1986K863411GUTTA PERCHAEKMSubstantially EquivalentEndodent, Inc.accessdata.fda.gov
June 14, 1982K821625ENDODONTIC PAPERPOINTSEKNSubstantially EquivalentRoekoaccessdata.fda.gov
August 27, 1980K801639PERMITE DENTAL AMALGAM ALLOYEJJSubstantially EquivalentSouthern Dental Industries, Inc.accessdata.fda.gov
November 15, 1976K760986CARBIDE DENTAL BURSEJLSubstantially EquivalentAdp Intl., Inc.accessdata.fda.gov

Compare with other makers

Updated September 18, 2020. 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.