Dental Device Guide
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Registered with FDA

Bina Limited

COROZAL, Belize. Lists 16 dental device types with FDA across 1 registered establishment.

FDA owner/operator10052298Foreign exporter
Device types listed
16
Brands and models
19
510(k) clearances
0as applicant
Markets registered in
1United States
Establishments
1Belize

Devices listed with FDA

What Bina Limited currently lists, by FDA device type, with the brand and model names on the listing.

Device typeCategoryRoleBrands and modelsListed since
Dental CementEMA · Class 2Dental cementsLister
DENTAL CEMENTSEALANT
2017
Resin Tooth Shade MaterialEBF · Class 2Dental compositesLister
Material, tooth shade, resinSEALANT
2017
Root Canal Filling ResinKIF · Class 2Root canal filling materialsLister
root canal fillingTIPS IRRIGATION MTA
2025
Amalgam AlloyEJJ · Class 2—Lister
Alloy, amalgam
2019
Dental BurEJL · Class 1Dental burs & diamondsLister
DENTAL BUR
2020
Resin Tooth Bonding AgentKLE · Class 2Bonding agentsLister
DENTAL BOND
2021
Dental Diamond InstrumentDZP · Class 1Dental burs & diamondsLister
DIAMIOND BUR
2024
Pit and Fissure Sealant and ConditionerEBC · Class 2Sealants & varnishesLister
SEALANT
2021
Oral Irrigation UnitEFS · Class 1Oral irrigatorsLister
Steri Irrigation Tips
2026
All Types RetractorEIG · Class 1Dental hand instrumentsLister
RETRACTOR
2022
Dental Instrument HandleEJB · Class 1Dental hand instrumentsLister
DENTAL HANDLE
2022
Oral Cavity Abrasive Polishing AgentEJR · Class 1Polishing & prophylaxisLister
ABRASIVE
2021
Gutta-PerchaEKM · Class 1Root canal filling materialsLister
GUTTA-PERCHA
2025
Endodontic Paper PointEKN · Class 1Root canal filling materialsLister
paper points
2025
Endodontic Pulp Canal FileEKS · Class 1Endodontic filesLister
DENTAL FILE
2020
Root Canal PostELR · Class 1Root canal filling materialsLister
ENDODONTIC POST
2023

Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026

Also lists devices cleared under other names

Bina Limited lists these devices with FDA today. The clearance names a different applicant, as happens after a rename, an acquisition or a private-label agreement.

Original applicants: Southern Dental Industries, Inc. (12), DiaDent Group International (3), Dharma Research, Inc. (1), Sdi Limited (1), Hager Worldwide, Inc. (1), Coltene/Whaledent AG (1), Shofu Inc (1), Microcopy, Div. Neo-Flo, Inc. (1).

Decided510(k)DeviceApplicantDevice type
18 Sep 2020K200174DIA-ROOT BIO MTADiaDent Group InternationalKIF Root Canal Filling Resin
25 Jun 2020K200175DIA-ROOT BIO SealerDiaDent Group InternationalKIF Root Canal Filling Resin
3 Jun 2019K182625Diapex PlusDiaDent Group InternationalKIF Root Canal Filling Resin
23 Jun 2015K150696Jade 37% Phosphoric Acid Etchant GelDharma Research, Inc.KLE Resin Tooth Bonding Agent
8 Dec 2010K102984AURASdi LimitedEBF Resin Tooth Shade Material
15 Nov 2006K062065RIVA LUTING PLUSSouthern Dental Industries, Inc.EMA Dental Cement
15 Jun 2005K051008SETSouthern Dental Industries, Inc.EMA Dental Cement
3 Jun 2005K050870RIVA LIGHT CURESouthern Dental Industries, Inc.EMA Dental Cement
27 May 2005K050658RESO-PAC PERIODONTAL DRESSINGHager Worldwide, Inc.EMA Dental Cement
7 Dec 2004K042452RIVA SILVERSouthern Dental Industries, Inc.EMA Dental Cement
30 Apr 2004K040393RIVA LUTINGSouthern Dental Industries, Inc.EMA Dental Cement
17 Apr 2003K030516RIVA-SELF CURESouthern Dental Industries, Inc.EMA Dental Cement
22 Oct 2001K012528ICESouthern Dental Industries, Inc.EBF Resin Tooth Shade Material
8 Dec 1997K973091WAVESouthern Dental Industries, Inc.EBF Resin Tooth Shade Material
8 Dec 1997K973092STAESouthern Dental Industries, Inc.KLE Resin Tooth Bonding Agent
24 Jan 1996K955285GALLOYSouthern Dental Industries, Inc.EJJ Amalgam Alloy
5 Jul 1994K941899SDI COMPOSTIESSouthern Dental Industries, Inc.EBF Resin Tooth Shade Material
6 Jun 1994K934192PARAPOST XT SYSTEMColtene/Whaledent AGELR Root Canal Post
14 Aug 1990K896071ULTRA II PORCELAIN POLISHING PASTEShofu IncEJR Oral Cavity Abrasive Polishing Agent
13 Feb 1989K885233NOVA DIAMONDMicrocopy, Div. Neo-Flo, Inc.DZP Dental Diamond Instrument
30 Oct 1986K863411GUTTA PERCHAEndodent, Inc.EKM Gutta-Percha
14 Jun 1982K821625ENDODONTIC PAPERPOINTSRoekoEKN Endodontic Paper Point
27 Aug 1980K801639PERMITE DENTAL AMALGAM ALLOYSouthern Dental Industries, Inc.EJJ Amalgam Alloy
15 Nov 1976K760986CARBIDE DENTAL BURSAdp Intl., Inc.EJL Dental Bur

Registered establishments

EstablishmentLocationWhat it does
BINA LIMITEDFDA reg. 3012627824COROZAL, BelizeForeign exporter

Sources

FDA establishment registration & device listing (search FDA, owner/operator 10052298). FDA 510(k) premarket notification file. FDA data as of 2 Nov 2026; snapshot 12 Nov 2026. The location shown is the address on FDA's record.