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Orthodontic Acrylic - EUDAMED Registration D6501503BLK0

Access comprehensive regulatory information for Orthodontic Acrylic in the European Union medical device market through Pure Global AI's free database. This Class I device is registered with EU EUDAMED under Primary DI D6501503BLK0 and manufactured by Lang Dental Manufacturing Company, Inc. in United States.

This page provides complete registration details including trade name (CONTEMPORARY ORTHO JET), manufacturer information, authorized representative details, competent authority (Agence Nationale de Sรฉcuritรฉ du Mรฉdicament et des Produits de Santรฉ), and regulatory compliance data from the official EU EUDAMED medical device database. Pure Global AI offers free access to the European Union's complete medical device registry, helping global MedTech companies navigate EU MDR regulations efficiently.

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EUDAMED Official Data
Class I
D6501503BLK0
No
Orthodontic Acrylic
Trade Name: CONTEMPORARY ORTHO JET
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Device Description (EMDN)

MATERIALS FOR THE PREPARATION OF CUSTOM-MADE DENTAL DEVICES - OTHER

Device Classification
Risk Class
Class I
CND Nomenclatures Code
Q010699
Trade Name
CONTEMPORARY ORTHO JET
Implantable
No
Reusable
No
Measuring Function
No
Registration Information
Primary DI
D6501503BLK0
Basic UDI
++D650136X
Version Date
November 04, 2024
Manufacturer Last Update
April 29, 2021
Active Status
No
Manufacturer
Country
United States
Country Type
NON_EU
Address
175 Messner Drive 969 Wheeling
Email
dlang@langdental.com
Authorized Representative
SRN
FR-AR-000000182
Country
France
Address
11 RUE EMILE ZOLA GRENOBLE
Email
info@medimark-europe.com
Telephone
+33 4 76 86 43 22
Regulatory Information
Competent Authority
Agence Nationale de Sรฉcuritรฉ du Mรฉdicament et des Produits de Santรฉ
Applicable Legislation
MDR (REGULATION (EU) 2017/745 on medical devices)
Placed On The Market
Germany
Device Characteristics
Human Tissues
No
Animal Tissues
No