Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3010462491

FEI Number

3010462491

Entity Name

DW Lingual Systems GmbH

City/State/Country

Bad Essen Lower Saxony, DE

Establishment Address

Lindenstrasse 44, Bad Essen Lower Saxony 49152, DE

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

DW LIngual Systems GmbH (Owner Number: 10045023)

Owner / Operator Contact Address

Lindenstrasse 44, Bad Essen, DE-NI 49152, DE

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

WIN

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
EJF	Bracket, Metal, Orthodontic	Dental	Class 1	872.5410	2013-09-16

Official Correspondent

Janina Kachel

US Agent Details

Lawrence J DDS Ms Levens Business: Lawrence J Levens, DDS,, MS, P.C. Email: larrylevens16@gmail.com Phone: (314) 8723218

Related Public Records

Same Entity

DW LIngual Systems GmbH

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 3010462491. Last updated year: 2026. Please use registration number 3010462491 when referencing this establishment in official correspondence.