EMA-SLEEP INC

FDA Device Registration & Listing · Bastrop, TX, US · Registration 3039643908

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3039643908
FEI Number
3039643908
Entity Name
EMA-SLEEP INC
City/State/Country
Bastrop, TX, US
Establishment Address
101 Gaston Dr, Bastrop, TX 78602, US
Establishment Type(s)
Develop Specifications But Do Not Manufacture At This Facility
Owner / Operator
EMA-Sleep Inc (Owner Number: 10093941)
Owner / Operator Contact Address
101 Gaston Dr, Bastrop, TX 78602, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
PMA Number
N/A

All Registered Proprietary Names

EMA 3D

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
LQZ Device, Jaw Repositioning Dental Class 2 872.5570 2025-08-14
LRK Device, Anti-Snoring Dental Class 2 872.5570 2025-08-14

Official Correspondent

Joe Frantz

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

EMA-Sleep 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

Similar Registrations

Registration Number Establishment Name Location
3030914478 GELB PRACTICE Dix Hills, NY, US
3017092365 APNOMED, INC. Bellevue, WA, US
3005726841 BIOTEX, INC. HOUSTON, 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 3039643908. Last updated year: 2026. Please use registration number 3039643908 when referencing this establishment in official correspondence.
Legal Disclaimer: AvaSpecs is not affiliated with the FDA or any government agency and does not provide medical, legal, regulatory, safety, approval, clearance, effectiveness, endorsement, or compliance advice. This index page is built using public record archives and does not represent an official regulatory determination.
Account Required Full available specs will require a free AvaSpecs account.