Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

8010019

FEI Number

3004588608

Entity Name

The Myerson Company Limited

City/State/Country

Laventille San Juan/Laventille, TT

Establishment Address

3 Trinity Avenue, Laventille San Juan/Laventille 00000, TT

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

THE MYERSON COMPANY LTD (Owner Number: 9049721)

Owner / Operator Contact Address

3 Trinity Avenue, --, Laventille, TT-SJL 00000, TT

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K160498

PMA Number

N/A

All Registered Proprietary Names

DuraFlex VisiClear DuraCetal Zirlux EMA Custom EMA CAD EMA PermaSoft Trusana1 Trusana Dentivera

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
EBI	Resin, Denture, Relining, Repairing, Rebasing	Dental	Class 2	872.3760	2009-12-03
EBI	Resin, Denture, Relining, Repairing, Rebasing	Dental	Class 2	872.3760	2017-11-06
LRK	Device, Anti-Snoring	Dental	Class 2	872.5570	2015-12-02
EBI	Resin, Denture, Relining, Repairing, Rebasing	Dental	Class 2	872.3760	2021-02-19
PZY	Additively Manufactured, Preformed, Resin Denture Tooth	Dental	Class 2	872.3590	2021-08-05
EBI	Resin, Denture, Relining, Repairing, Rebasing	Dental	Class 2	872.3760	2020-12-10

Official Correspondent

No official correspondent registered.

US Agent Details

Hector Mellado Business: Myerson LLC Email: qa@myersontooth.com Phone: (312) 4238200

Related Public Records

Same Entity

THE MYERSON COMPANY LTD

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
K800400	Dentsply Intl.	MAXUM DENTURE RESIN	1980-03-12
K033020	Cmp Industries, LLC	IMPAK ACRYLIC REPAIR RESIN LIQUID	2003-12-19
K122391	Medtronic Xomed, Inc.	MEDTRONIC XOMED, INC.	2013-01-10

Similar Registrations

Registration Number	Establishment Name	Location
3017374693	STRATASYS LTD - Headquarter	Rehovot Central, IL
2950685	CO-ORAL-ITE DENTAL MFG. CO.	DIAMOND SPRINGS, CA, US
3032727	TALON ACRYLICS, INC.	Winchester, OR, US
3008320092	Shandong Huge Dental Material Corporation	Rizhao Shandong, CN
1410097	GC AMERICA INC.	ALSIP, IL, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 8010019. Last updated year: 2026. Please use registration number 8010019 when referencing this establishment in official correspondence.