KLOWEN BRACES DBA KLOWEN ORTHODONTICS

FDA Device Registration & Listing · Richardson, TX, US · Registration 3030265369

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
3030265369
FEI Number
3030265369
Entity Name
KLOWEN BRACES DBA KLOWEN ORTHODONTICS
City/State/Country
Richardson, TX, US
Establishment Address
1703 N. Plano Road, Ste. 200, Richardson, TX 75081, US
Establishment Type(s)
Repack or Relabel Medical Device
Owner / Operator
KLOwen Braces dba KLOwen Orthodontics (Owner Number: 10089784)
Owner / Operator Contact Address
1703 N. Plano Road, Ste. 200, Richardson, TX 75081, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
PMA Number
N/A

All Registered Proprietary Names

KLOwen Orthodontic Solution

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
DYW Bracket, Plastic, Orthodontic Dental Class 2 872.5470 2025-05-08

Official Correspondent

Tony Sapp

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

KLOwen Braces dba KLOwen Orthodontics
View consolidated registration, premarket clearance, and recall records for this applicant.
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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3030265369. Last updated year: 2026. Please use registration number 3030265369 when referencing this establishment in official correspondence.
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