ERKODENT ERICH KOPP GMBH

FDA Device Registration & Listing · PFALZGRAFENWEILER Baden-Wurttemberg, DE · Registration 8010662

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
8010662
FEI Number
5513
Entity Name
ERKODENT ERICH KOPP GMBH
City/State/Country
PFALZGRAFENWEILER Baden-Wurttemberg, DE
Establishment Address
SIEMENSSTR. 3, PFALZGRAFENWEILER Baden-Wurttemberg 72285, DE
Establishment Type(s)
Manufacture Medical Device
Owner / Operator
Erkodent Erich Kopp GmbH (Owner Number: 8010662)
Owner / Operator Contact Address
Siemensstrasse 3, Pfalzgrafenweiler, DE-NOTA D-72285, DE
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

Erkolign Erkolen Erkoplast PLA Erkoflex Erkodur Playsafe triple Erkoloc-pro ERKOFLEX AND ERKOPLAST

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
KMY Positioner, Tooth, Preformed Dental Class 1 872.5525 2021-04-08
MQC Mouthguard, Prescription Unknown Class U N/A 2021-04-08
EHY Tray, Impression, Preformed Dental Class 1 872.6880 2004-05-20

Official Correspondent

Hans-Peter Kopp

US Agent Details

Jon Ward Business: AJW Technology Consultants, Inc. Email: usagent@ajwtech.com Phone: (813) 6452855

Related Public Records

Same Entity

Erkodent Erich Kopp 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 8010662. Last updated year: 2026. Please use registration number 8010662 when referencing this establishment in official correspondence.
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