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 - Orametrix Inc (Texas)

Address:

2350 Campbell Creek Blvd. Suite 400 Dentsply Sirona Orthodontics Inc

Richardson

Texas 75082

United States

Authorised Representative/ UK Responsible Person
Name: Dentsply IH Limited
Address:

Building 3 The Heights Brooklands

Weybridge

Surrey KT13 0NY

England United Kingdom

Code/Term Type

CAD/CAM software CAD/CAM software Class IIa

Orthodontic progressive aligner Orthodontic progressive aligner Class IIa

Orthodontic archwire Orthodontic archwire Class IIa

Orthodontic retainer Orthodontic retainer Class IIa

Orthodontic appliance positioning tray Orthodontic appliance positioning tray 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
CAD/CAM software	CAD/CAM software	Class IIa
Orthodontic progressive aligner	Orthodontic progressive aligner	Class IIa
Orthodontic archwire	Orthodontic archwire	Class IIa
Orthodontic retainer	Orthodontic retainer	Class IIa
Orthodontic appliance positioning tray	Orthodontic appliance positioning tray	Class I