Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3005726841

FEI Number

3005726841

Entity Name

BIOTEX, INC.

City/State/Country

HOUSTON, TX, US

Establishment Address

114 Holmes Rd, HOUSTON, TX 77045, US

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

BIOTEX, INC. (Owner Number: 9079181)

Owner / Operator Contact Address

114 Holmes Rd, --, Houston, TX 77045, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

The Slide SurgiLux troCarWash System troCarWash Automated Visualization System Slide Bite Fork

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
LQZ	Device, Jaw Repositioning	Dental	Class 2	872.5570	2021-08-19
LRK	Device, Anti-Snoring	Dental	Class 2	872.5570	2021-08-19
FTD	Lamp, Surgical	General, Plastic Surgery	Class 2	878.4580	2019-06-27
OCX	Endoscopic Irrigation/Suction System	Gastroenterology, Urology	Class 2	876.1500	2024-08-12
FEQ	Pump, Air, Non-Manual, For Endoscope	Gastroenterology, Urology	Class 2	876.1500	2024-08-12
EHY	Tray, Impression, Preformed	Dental	Class 1	872.6880	2025-02-20

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

BIOTEX, INC.

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
K122391	Medtronic Xomed, Inc.	MEDTRONIC XOMED, INC.	2013-01-10

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0010-2023	Hobbs Medical, Inc.	2	Hobbs Medical Spray Catheter: The Mistifier: 2.6mm 260cm Disposable For endoscopy procedures Ref: 2190
Z-0011-2023	Hobbs Medical, Inc.	2	Hobbs Medical Spray Catheter: The Mistifier: 2.6mm 165cm Disposable For endoscopy procedures Ref: 2191

Similar Registrations

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3017092365	APNOMED, INC.	Bellevue, WA, US
3039643908	EMA-SLEEP INC	Bastrop, TX, US
3030562551	AIOMEGA, LLC	Tyler, TX, US
9615291	AURUM CERAMIC DENTAL LABORATORIES LTD.	CALGARY Alberta, CA

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3005726841. Last updated year: 2026. Please use registration number 3005726841 when referencing this establishment in official correspondence.