Data / Medical devices / Trinidad and Tobago / The Myerson Company Limited

The Myerson Company Limited: FDA-registered device maker in Laventille San JuanLaventille, Trinidad and Tobago, 8 510(k) clearances

Name: The Myerson Company Limited FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

The Myerson Company Limited is registered with the FDA (registration 8010019) in Laventille San JuanLaventille, Trinidad and Tobago. It lists 5 device types. The FDA files 8 510(k) clearances under its listings, the newest dated April 13, 2023. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number: 8010019
FEI number: 3004588608
Address: 3 Trinity Avenue, Laventille San JuanLaventille, Trinidad and Tobago, 00000
Owner or operator: THE MYERSON COMPANY LTD (9049721)
Roles: Contract manufacturer, Manufacturer, Specification developer
First device listed: November 3, 2009
Registered through: 2026
Brand names listed: Dentivera, DurAcetal, DuraCetal, DuraFlex, EMA, EMA CAD, EMA Custom, Kenson and more

Devices it lists

Device	Product code	Class	Role	Source
Additively Manufactured, Preformed, Resin Denture Tooth	PZY	2	Manufacturer	accessdata.fda.gov
Clasp, Preformed	EHP	1	Manufacturer	accessdata.fda.gov
Denture, Plastic, Teeth	ELM	2	Manufacturer	accessdata.fda.gov
Device, Anti-Snoring	LRK	2	Manufacturer, Specification developer	accessdata.fda.gov
Resin, Denture, Relining, Repairing, Rebasing	EBI	2	Contract manufacturer, Manufacturer, Specification developer	accessdata.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.

Decided	510(k) number	Device	Product code	Decision	Applicant	Source
April 13, 2023	K230098	Trusana	EBI	Substantially Equivalent	Myerson, LLC	accessdata.fda.gov
November 2, 2017	K172407	Duracetal	EBI	Substantially Equivalent	The Myerson Company Limited	accessdata.fda.gov
June 15, 2016	K160498	Dentivera Milling Disc	EBI	Substantially Equivalent	Dental Solutions, LLC	accessdata.fda.gov
February 8, 2007	K063626	DURAFLEX	EBI	Substantially Equivalent	Cosmetic Dental Materials, Inc.	accessdata.fda.gov
August 29, 2002	K022032	ACETAL	EHP	Substantially Equivalent	Inovativ, LLC	accessdata.fda.gov
September 29, 1997	K971794	ELASTIC MANDIBULAR ADVANCEMENT (EMA) APPLIANCE	LRK	Substantially Equivalent	Frantz Design, Inc.	accessdata.fda.gov
January 5, 1994	K933468	MYERSON'S PERMASOFT SOFT RELINE MATERIAL	EBI	Substantially Equivalent	Austenal, Inc.	accessdata.fda.gov
November 4, 1992	K924526	DENTURE PLASTIC TEETH	ELM	Substantially Equivalent	Austenal, Inc.	accessdata.fda.gov

Compare with other makers

Updated April 13, 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.