Manufacturer registered with FDA

Biotex, Inc.

Houston, TX, United States. Lists 3 dental device types with FDA across 1 registered establishment, and holds 1 510(k) clearance as applicant.

FDA owner/operator9079181Manufacturer

Device types listed: 3
Brands and models: 3
510(k) clearances: 12021–2021
Markets registered in: 211 registrations outside the US
Establishments: 1United States

510(k) clearances per year, 2007–2026

Registered in 2 markets

Where regulators' registries name Biotex, Inc. as the manufacturer or the registration holder of a device.

All markets

RegisteredHome: United StatesOne marker per market

Market	Regulator	Named as	Name on the registry	Registrations	Issued	Records
United States	FDA	Manufacturer	Biotex, Inc.	1 clearances	2021–2021	Below
Argentina	ANMAT	Registration holder	BIOTEX SRL.	11	—	Pure Global AI

Outside the US the count is of all the company's device registrations in that market, dental or not · matched by company name and country · registry data read 12 Nov 2026

Devices listed with FDA

What Biotex, Inc. currently lists, by FDA device type, with the brand and model names on the listing.

Device type	Category	Role	Brands and models	Listed since
Preformed Impression TrayEHY · Class 1	Impression trays	Maker	Slide Bite Fork	2025
Jaw Repositioning DeviceLQZ · Class 2	Anti-snoring & jaw-repositioning devices	Maker	The Slide	2021
Anti-Snoring DeviceLRK · Class 2	Anti-snoring & jaw-repositioning devices	Maker	The Slide	2021

Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026

510(k) clearances

Clearances on which FDA names Biotex, Inc. as the applicant.

Decided	510(k)	Device	Device type
20 Jul 2021	K203712	The Slide	LQZ Jaw Repositioning Device

Registered establishments

Establishment	Location	What it does
BIOTEX, INC.FDA reg. 3005726841	HOUSTON, TX, United States	Manufacturer

Sources

FDA establishment registration & device listing (search FDA, owner/operator 9079181). FDA 510(k) premarket notification file. FDA data as of 2 Nov 2026; snapshot 12 Nov 2026. The location shown is the address on FDA's record.