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 - Roe Dental Laboratory; Inc

Address:

7165 E Pleasant Valley Rd

Independence

Ohio OH 44131

United States

Authorised Representative/ UK Responsible Person
Name: QUORIS3D Limited
Address:

17 Tully Road

Irvinestown

Enniskillen

Fermanagh BT94 1RL

Northern Ireland United Kingdom

Code/Term Type

Dental implant suprastructure permanent custom-made Dental implant suprastructure permanent custom-made Class IIa

Dental prosthesis bite verification device Dental prosthesis bite verification device Class IIa

Complete lower denture Complete lower denture Class IIb

Complete upper denture Complete upper denture Class IIb

Osteotomy guide single-use Osteotomy guide single-use Class IIa

Custom-made organ/bone anatomy model/surgical guide kit Custom-made organ/bone anatomy model/surgical guide kit Class IIa

Dental bridge polymer Dental bridge polymer Class IIb

Dental bridge polymer Dental bridge polymer Class IIb

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
Dental implant suprastructure permanent custom-made	Dental implant suprastructure permanent custom-made	Class IIa
Dental prosthesis bite verification device	Dental prosthesis bite verification device	Class IIa
Complete lower denture	Complete lower denture	Class IIb
Complete upper denture	Complete upper denture	Class IIb
Osteotomy guide single-use	Osteotomy guide single-use	Class IIa
Custom-made organ/bone anatomy model/surgical guide kit	Custom-made organ/bone anatomy model/surgical guide kit	Class IIa
Dental bridge polymer	Dental bridge polymer	Class IIb
Dental bridge polymer	Dental bridge polymer	Class IIb