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Dental Abutment - EUDAMED Registration 00813110029492

Access comprehensive regulatory information for Dental Abutment in the European Union medical device market through Pure Global AI's free database. This Class IIb device is registered with EU EUDAMED under Primary DI 00813110029492 and manufactured by Bicon, LLC in United States.

This page provides complete registration details including trade name (Temporary), manufacturer information, authorized representative details, competent authority (Health Products Regulatory Authority, Medical Devices Department), 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 IIb
00813110029492
No
Dental Abutment
Trade Name: Temporary
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Device Description (EMDN)

ODONTOLOGICAL PROSTHESES - OTHER

Device Classification
Risk Class
Class IIb
CND Nomenclatures Code
P010299
Trade Name
Temporary
Implantable
Yes
Reusable
No
Measuring Function
No
Registration Information
Primary DI
00813110029492
Basic UDI
081311002TAbut5L
Version Date
January 14, 2025
Manufacturer Last Update
December 11, 2023
Active Status
No
Manufacturer
Manufacturer Name
Bicon, LLC
Country
United States
Country Type
NON_EU
Address
501 Arborway Boston
Email
support@bicon.com
Authorized Representative
SRN
IE-AR-000002497
Country
Ireland
Address
Unit 4, Ballycummin Village, Limerick
Email
ocoday@bicon.com
Telephone
0035361303494
Regulatory Information
Competent Authority
Health Products Regulatory Authority, Medical Devices Department
Applicable Legislation
MDR (REGULATION (EU) 2017/745 on medical devices)
Placed On The Market
Ireland
Market Available
Austria:None~None, Belgium:None~None, Bulgaria:None~None, Croatia:None~None, Cyprus:None~None, Czechia:None~None, Denmark:None~None, Estonia:None~None, Finland:None~None, France:None~None, Germany:None~None, Greece:None~None, Hungary:None~None, Iceland:None~None, Ireland:None~None, Italy:None~None, Latvia:None~None, Liechtenstein:None~None, Lithuania:None~None, Luxembourg:None~None, Malta:None~None, Netherlands:None~None, Norway:None~None, Poland:None~None, Portugal:None~None, Romania:None~None, Slovakia:None~None, Slovenia:None~None, Spain:None~None, Sweden:None~None, Türkiye:None~None, United Kingdom (Northern Ireland only):None~None
Device Characteristics
Human Tissues
No
Animal Tissues
No