Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3012627824

FEI Number

3012627824

Entity Name

BINA LIMITED

City/State/Country

COROZAL, BZ

Establishment Address

KUNAL PLAZA, FREEDOM AVENUE,, COROZAL FREE ZONE, SANTA ELENA BORDER, COROZAL 01, BZ

Establishment Type(s)

Export Device to the United States But Perform No Other Operation on Device

Owner / Operator

BINA LIMITED (Owner Number: 10052298)

Owner / Operator Contact Address

KUNAL PLAZA, FREEDOM AVENUE,, COROZAL FREE ZONE, SANTA ELENA BORDER, COROZAL, BZ-CZL 01, BZ

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K973092

PMA Number

N/A

All Registered Proprietary Names

paper points root canal filling DENTAL CEMENT DENTAL CEMENT ABRASIVE GUTTA-PERCHA Material, tooth shade, resin Material, tooth shade, resin ROOT CANAL FILLING DENTAL BOND DENTAL CEMENT DENTAL BUR Steri Irrigation Tips DENTAL HANDLE DENTAL CEMENT Alloy, amalgam DENTAL BUR RETRACTOR ENDODONTIC POST TIPS IRRIGATION MTA SEALANT Alloy, amalgam DENTAL BOND

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
EKN	Point, Paper, Endodontic	Dental	Class 1	872.3830	2025-01-08
KIF	Resin, Root Canal Filling	Dental	Class 2	872.3820	2025-01-08
EMA	Cement, Dental	Dental	Class 2	872.3275	2017-12-26
EMA	Cement, Dental	Dental	Class 2	872.3275	2021-02-19
EJR	Agent, Polishing, Abrasive, Oral Cavity	Dental	Class 1	872.6030	2021-02-20
EKM	Gutta-Percha	Dental	Class 1	872.3850	2025-01-08
EBF	Material, Tooth Shade, Resin	Dental	Class 2	872.3690	2017-12-26
EBF	Material, Tooth Shade, Resin	Dental	Class 2	872.3690	2017-12-26
KIF	Resin, Root Canal Filling	Dental	Class 2	872.3820	2025-01-08
KLE	Agent, Tooth Bonding, Resin	Dental	Class 2	872.3200	2021-02-20
EMA	Cement, Dental	Dental	Class 2	872.3275	2018-06-27
EJL	Bur, Dental	Dental	Class 1	872.3240	2020-07-23
EFS	Unit, Oral Irrigation	Dental	Class 1	872.6510	2026-06-15
EJB	Handle, Instrument, Dental	Dental	Class 1	872.4565	2022-05-09
EMA	Cement, Dental	Dental	Class 2	872.3275	2021-02-19
EJJ	Alloy, Amalgam	Dental	Class 2	872.3070	2019-12-23
EJL	Bur, Dental	Dental	Class 1	872.3240	2024-07-19
EIG	Retractor, All Types	Dental	Class 1	872.4565	2022-05-09
ELR	Post, Root Canal	Dental	Class 1	872.3810	2023-06-27
KIF	Resin, Root Canal Filling	Dental	Class 2	872.3820	2026-06-15
EBC	Sealant, Pit And Fissure, And Conditioner	Dental	Class 2	872.3765	2021-02-19
EMA	Cement, Dental	Dental	Class 2	872.3275	2021-02-19
EBF	Material, Tooth Shade, Resin	Dental	Class 2	872.3690	2021-02-19
EJJ	Alloy, Amalgam	Dental	Class 2	872.3070	2019-12-23
KLE	Agent, Tooth Bonding, Resin	Dental	Class 2	872.3200	2021-02-19

Official Correspondent

ISRAEL MANZANILLA

US Agent Details

ISRAEL MANZANILLA Business: BINA LIMITED Email: contact@binaltdbz.com Phone: (786) 5676179

Related Public Records

Same Entity

BINA LIMITED

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K972485	Arent, Fox, Kintner, Plotkin & Kahn	CIMPAT N	1997-09-08
K982895	Sterngold/Implamed	STERNOMEGA COMPOMER CEMENT	1998-10-09
K033068	Voco GmbH	IONOFIL COLOR AC	2003-10-31
K062064	Southern Dental Industries, Inc.	RIVA BOND LC	2006-11-09
K940030	Bisco, Inc.	BISCO COMPOSITE	1994-02-04

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0028-2020	Voco GmbH Anton-Flettner-Str. 1-3 Cuxhaven Germany	2	Grandio SO Heavy Flow Caps, Color A3 - Product Usage: Filling minimally invasive cavities of all classes - Filling small class I cavities and extended fissure sealing - Filling class II - V cavities including V-shaped defects and cervical caries - Blocking out undercuts - Lining or coating cavities - Repairing fillings and veneers - Luting translucent prosthetic pieces (e.g., full ceramic crowns, etc.).
Z-0035-2008	Heraeus Kulzer Inc., Dental Products Division	2	Heraeus Kulzer GLUMA Comfort Bond + Desensitizer light curing one component adhesive, contents: 4 ml, dental bonding agent. Distributed by Heraeus Kulzer, Inc., Armonk, NY; Reorder No. 66001710.
Z-0036-2008	Heraeus Kulzer Inc., Dental Products Division	2	Heraeus Kulzer GLUMA Comfort Bond + Desensitizer light curing one component adhesive, Assortment Value Pack 3 x 4 ml, dental bonding agent. Distributed by Heraeus Kulzer, Inc., Armonk, NY; Reorder No. 66018222.

Similar Registrations

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3011554142	SHENZHEN DENCO MEDICAL CO., LTD.	Shenzhen Guangdong, CN
2086043	PAC-DENT INC.	Brea, CA, US
3012996495	VIARDEN LAB LLC	Mission, TX, US
2024312	Kerr Corporation	ORANGE, CA, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3012627824. Last updated year: 2026. Please use registration number 3012627824 when referencing this establishment in official correspondence.