United Kingdom MHRA device registration 93486

Orthodontic progressive aligner

United Kingdom·General Medical Device·Orametrix Inc (Texas)·Registered Nov 26, 2024

Registration details

Device ID: 93486
MHRA Reference Number: 93486
Date Registered: Nov 26, 2024
Last Updated: May 8, 2024

Device classification

Device Type: General Medical Device
Devices: Orthodontic progressive aligner
Type: Custom-made - Class IIa

Manufacturer

Name: Orametrix Inc (Texas)
Address: 2350 Campbell Creek Blvd. Suite 400 Dentsply Sirona Orthodontics Inc
Richardson, Texas, United States
Created Date: Jun 23, 2021

Authorized Representative

Name: Dentsply IH Limited
Relationship Type: UK Responsible Person
Address: Building 3, The Heights Brooklands
Weybridge, Surrey, England, United Kingdom
Postcode: KT13 0NY

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About this record

Orthodontic progressive aligner is a medical device registered with the UK's Medicines and Healthcare products Regulatory Agency (MHRA) under Device ID 93486. The device is manufactured by Orametrix Inc (Texas) from United States, classified as General Medical Device. The authorized representative in the UK is Dentsply IH Limited.

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