Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3016051804

FEI Number

3016051804

Entity Name

DENTORTHO LLC

City/State/Country

Chicago, IL, US

Establishment Address

5455 W North Ave, Chicago, IL 60639, US

Establishment Type(s)

Repack or Relabel Medical Device

Owner / Operator

DentOrtho LLC (Owner Number: 10061910)

Owner / Operator Contact Address

5455 W North Ave, Chicago, IL 60639, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

No proprietary names listed under this establishment.

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
EJF	Bracket, Metal, Orthodontic	Dental	Class 1	872.5410	2019-12-02
JEX	Plier, Orthodontic	Dental	Class 1	872.4565	2019-12-02
ECM	Band, Preformed, Orthodontic	Dental	Class 1	872.5410	2019-12-02

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

DentOrtho LLC

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
K894358	Ormco Corp.	LUMINA ORTHODONTIC BRACKET	1989-09-15
K925012	American Orthodontics	PLASTIC CHAIN	1993-09-13

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3016051804. Last updated year: 2026. Please use registration number 3016051804 when referencing this establishment in official correspondence.