Public Access Database for Medical Device Registration

Registration does not represent any form of accreditation, certification or approval by the UK Competent Authority(MHRA)
Where a conformity assessment certificate is listed as expired, existing products already placed on the market prior to the expiry may not be affected by this expiry and can continue to be used. This expiry stops new products being placed on the market until there is a new certificate of conformity

Manufacturer's By Name

By Device

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Manufacturer's Devices - EnvisionTEC GmbH

Address:

Brüsseler Str. 51

Gladbeck

NRW 45968

Germany

Authorised Representative/ UK Responsible Person
Name: Emergo Consulting (UK) Limited
Address:

Compass House Vision Park Histon c/o Cr360 – UL International

Cambridge

CB24 9BZ

England United Kingdom

Code/Term Type

Custom-made mouthguard Custom-made mouthguard Class IIa

Dental occlusal splint custom-made Dental occlusal splint custom-made Class IIa

Dental impression tray material Dental impression tray material Class I

Denture base resin kit Denture base resin kit Class I

Dental guided surgery reference plate Dental guided surgery reference plate Class I

Resin artificial teeth Resin artificial teeth Class I

Contact details

Freedom of information

0203 080 7272 (manned 10:00-16:00 hours working days) device.registrations@mhra.gov.uk

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Code/Term		Type
Custom-made mouthguard	Custom-made mouthguard	Class IIa
Dental occlusal splint custom-made	Dental occlusal splint custom-made	Class IIa
Dental impression tray material	Dental impression tray material	Class I
Denture base resin kit	Denture base resin kit	Class I
Dental guided surgery reference plate	Dental guided surgery reference plate	Class I
Resin artificial teeth	Resin artificial teeth	Class I