FDA Registration
Active
🇺🇸 United States
MENTOR
Reg #: 1645337
·
FEI: 1000118360
·
Expires 2026
Products
8
Proprietary Names
23
Establishment Types
2
Classifications
8
Research this establishment in seconds
The Research Assistant profiles FDA-registered establishments — listings, owners, related facilities — and cites every record.
Free to try · every answer cites its records
Registration Details
- Registration Name
- MENTOR
- Registration Number
- 1645337
- FEI Number
- 1000118360
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 3041 SKYWAY CIRCLE NORTH
- City
- IRVING
- State
- TX
- ZIP
- 75038
- Country
- US
Regulatory Submissions
- 510(k) Number
- K152496
- PMA Number
- P990075
Owner / Operator
- Firm Name
- MENTOR Texas, LP
- Operator Number
- 2125050
- Address
- 3041 Skyway Cir N, --
- City
- Irving
- State
- TX
- Postal Code
- 75038
- Country
- US
- Correspondent
- Kristi Bodin
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Instrument, Manual, Surgical, General Use | MDM | Class 1 | General, Plastic Surgery | No | 2006-06-14 |
| Tissue Expander And Accessories | LCJ | Class U | Unknown | No | 2016-02-29 |
| Prosthesis, Breast, Inflatable, Internal, Saline | FWM | Class 3 | General, Plastic Surgery | No | 2008-03-07 |
| Mammary Sizer | MRD | Class U | Unknown | No | 2008-03-07 |
| System, Suction, Lipoplasty For Removal | QPB | Class 2 | General, Plastic Surgery | No | 2006-06-14 |
| Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled | FTR | Class 3 | General, Plastic Surgery | No | 2008-02-15 |
| Tubing, Noninvasive | GAZ | Class 2 | General Hospital | No | 2008-03-07 |
| Accessories, Catheter | KGZ | Class 1 | General, Plastic Surgery | No | 2008-11-21 |
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
Cannula
MENTOR MemoryGel Resterilizable Gel Breast Implant Sizer
MENTOR MemoryShape Resterilizable Gel Breast Implant Sizer
PSI-TEC Aspirators
Mentor CPX 4 Breast Tissue Expanders And Mentor CPX 4 With Suture Tabs Breast Tissue Expanders
MemoryShape Breast Implants
Aseptic Transfer Kit
Tubing
Contour Profile Tissue Expander (CPX)
Mentor CPX 4 Breast Tissue Expander with Smooth Surface
Artoura Breast Tissue Expander
Smooth Tissue Expanders
Establishment Types
Develop Specifications But Do Not Manufacture At This Facility
Manufacture Medical Device