Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

1645337

FEI Number

1000118360

Entity Name

MENTOR

City/State/Country

IRVING, TX, US

Establishment Address

3041 SKYWAY CIRCLE NORTH, IRVING, TX 75038, US

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

MENTOR Texas, LP (Owner Number: 2125050)

Owner / Operator Contact Address

3041 Skyway Cir N, --, Irving, TX 75038, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

P060028

All Registered Proprietary Names

Byron Cannula and Hand Instruments CPX4 Breast Tissue Expander 1445cc Saline Implants Spectrum Saline Implants Siltex Contour Profile Saline Implants Saline Sizers MENTOR MemoryGel Enhance Single Use Gel Sizer Mentor CPX 4 PLUS Enhance Breast Tissue Expanders Artoura Breast Tissue Expanders With Smooth Surface Sterile MemoryShape Resterilizable Gel Sizers MemoryGel Resterilizable Gel Sizers Mentor CPX 4 PLUS Enhance Breast Tissue Expanders Cannula MENTOR MemoryGel Resterilizable Gel Breast Implant Sizer MENTOR MemoryShape Resterilizable Gel Breast Implant Sizer MENTOR MemoryGel Enhance Single Use Gel Sizer PSI-TEC Aspirators Mentor CPX 4 Breast Tissue Expanders And Mentor CPX 4 With Suture Tabs Breast Tissue Expanders MemoryShape Breast Implants

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
MDM	Instrument, Manual, Surgical, General Use	General, Plastic Surgery	Class 1	878.4800	2006-06-14
LCJ	Tissue Expander And Accessories	Unknown	Class U	N/A	2016-02-29
FWM	Prosthesis, Breast, Inflatable, Internal, Saline	General, Plastic Surgery	Class 3	878.3530	2008-03-07
MRD	Mammary Sizer	Unknown	Class U	N/A	2008-03-07
MRD	Mammary Sizer	Unknown	Class U	N/A	2025-02-12
LCJ	Tissue Expander And Accessories	Unknown	Class U	N/A	2025-02-12
LCJ	Tissue Expander And Accessories	Unknown	Class U	N/A	2016-05-31
MRD	Mammary Sizer	Unknown	Class U	N/A	2015-06-30
MRD	Mammary Sizer	Unknown	Class U	N/A	2008-03-07
LCJ	Tissue Expander And Accessories	Unknown	Class U	N/A	2025-02-12
QPB	System, Suction, Lipoplasty For Removal	General, Plastic Surgery	Class 2	878.5040	2006-06-14
MRD	Mammary Sizer	Unknown	Class U	N/A	2025-02-12
QPB	System, Suction, Lipoplasty For Removal	General, Plastic Surgery	Class 2	878.5040	2010-12-10
LCJ	Tissue Expander And Accessories	Unknown	Class U	N/A	2013-06-03
FTR	Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled	General, Plastic Surgery	Class 3	878.3540	2008-02-15

Official Correspondent

Kristi Bodin

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

MENTOR Texas, LP

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

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3005423519	Mentor Texas LP	Coppell, TX, US

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K161483	Stradis Healthcare	Unger Quad Injector	2016-10-31

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0006-04	N/A	3	McGhan Style 40, Round Breast Implant, Standard Projection, Silicone-filled Smooth INTRASHIEL Barrier Catalog Numbers: 25-40401 25-40461 25-40501 25-40561

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 1645337. Last updated year: 2026. Please use registration number 1645337 when referencing this establishment in official correspondence.