Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

8010874

FEI Number

3005547450

Entity Name

SCHEU-DENTAL GMBH

City/State/Country

ISERLOHN North Rhine-Westphalia, DE

Establishment Address

AM BURGBERG 20, ISERLOHN North Rhine-Westphalia 58642, DE

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Scheu-Dental GmbH (Owner Number: 8010874)

Owner / Operator Contact Address

Am Burgberg 20, --, Iserlohn, DE-NOTA 58642, DE

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Herbst Orthodontic Retainer VECTOR Screw IST Appliance Telescopes Clasps preformed, Ball clasps, arrow clasps, J clasps, Voss clasps DURASOFT DURAN, DURAN+ DURASPLINT LC BIOPLAST, BIOPLAST XTREME HARDCAST DURASOFT, DURASOFT pd IMPRELON, IMPRELON S pd, IMPRELON S+ pd UNIQ, UNIQ+ BIOCRYL C COPYPLAST, COPYPLAST C

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
DYJ	Retainer, Screw Expansion, Orthodontic	Dental	Class 1	872.5410	2002-07-19
EHP	Clasp, Preformed	Dental	Class 1	872.3285	2002-07-19
KMY	Positioner, Tooth, Preformed	Dental	Class 1	872.5525	2009-06-09

Official Correspondent

Alireza Assadi

US Agent Details

Joseph Mazurkiewicz Business: GREAT LAKES DENTAL TECHNOLOGIES Email: JoeM@greatlakesdentaltech.com Phone: (800) 8287626

Related Public Records

Same Entity

Scheu-Dental GmbH

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 8010874. Last updated year: 2026. Please use registration number 8010874 when referencing this establishment in official correspondence.