Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

2529596

FEI Number

1000121324

Entity Name

Moldgenix LLC

City/State/Country

Trumbauersville, PA, US

Establishment Address

354 East Broad Street, Trumbauersville, PA 18970, US

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

Moldgenix LLC (Owner Number: 10090559)

Owner / Operator Contact Address

354 East Broad Street, PO Box 878, Trumbauersville, PA 18970, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Atos Medical The TheraBite® Jaw Motion Rehabilitation SystemTM DenTek Ultimate Dental Guard

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
ION	Exerciser, Non-Measuring	Physical Medicine	Class 1	890.5370	2024-04-12
OBR	Mouthguard, Over-The-Counter	Unknown	Class U	N/A	2024-04-12

Official Correspondent

Thomas Houdeshell

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Moldgenix LLC

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

View Entity Profile →

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 2529596. Last updated year: 2026. Please use registration number 2529596 when referencing this establishment in official correspondence.