DENTACO GmbH & Co. KG

FDA Device Registration & Listing · Essen North Rhine-Westphalia, DE · Registration 8010827

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
8010827
FEI Number
3004536970
Entity Name
DENTACO GmbH & Co. KG
City/State/Country
Essen North Rhine-Westphalia, DE
Establishment Address
Max-Keith - Str.46, Essen North Rhine-Westphalia D-45136, DE
Establishment Type(s)
Manufacture Medical Device,Manufacture Medical Device for Another Party (Contract Manufacturer)
Owner / Operator
Dentaco GmbH & Co. KG (Owner Number: 8010827)
Owner / Operator Contact Address
Max-Keith Str. 46, --, Essen, DE-NOTA D-45136, DE
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

ACCUFILM IV Scan Bite Boca Bite

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
EFH Paper, Articulation Dental Class 1 872.6140 2000-07-13
EGD Wax, Dental, Intraoral Dental Class 1 872.6890 2009-03-06

Official Correspondent

No official correspondent registered.

US Agent Details

Yasily Ogando Roa Business: Parkell, Inc Email: yogando@parkell.com Phone: (631) 3891560

Related Public Records

Same Entity

Dentaco GmbH & Co. KG
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 8010827. Last updated year: 2026. Please use registration number 8010827 when referencing this establishment in official correspondence.
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