Medical Device Classification and Declaration of Conformity
We hereby declare that the above-mentioned products meet the provisions of the United Kingdom Medical Devices Regulations 2002 as they apply in Great Britain (SI 2002 No 618, as amended).
According to MEDDEV 2.4/1 rev.9, Classification of medical devices, Rule 12, this stand-alone software is a Class I medical device (without measuring function).
According to MEDDEV 2.1.6 Qualification & classification of standalone Software, this is stand-alone software (reference page 7, paragraph 2.1).
According to EN62304, specifically the flowchart in section 4.3, this stand-alone software is safety class A.
Intended Use
AssistDent is an aid in the diagnosis of proximal surface caries; carious lesions that are present in the enamel and carious lesions that have penetrated into the dentine. It is not intended for primary diagnosis but is to be used as an adjunct to the dentist’s conventional sources of diagnostic information. It is designed to assist dentists to detect carious lesions that are difficult to detect or would require significant effort to identify. The final diagnostic decision rests with the dentist.
Indications for Use
Users
The use of this product to analyse patient data is restricted to qualified dentists, dental therapists and dental hygienists, regulated by the statutory regulatory bodies to prescribe radiographs, take them, process and interpret them for dental caries.
Patients
Patients, on whose images the product is applied, are restricted to adults attending their dentist for a dental examination and who receive digital intra-oral radiographs as part of their examination procedure.
Contraindications
The product should not be used to analyse primary teeth. The product should not be used to analyse images other than those intended to detect dental caries.
Warnings and Precautions
AssistDent is an advisory tool. AssistDent does not provide a definitive diagnosis of caries or tooth identification, rather it alerts the dentist to suspicious regions. Inspecting the regions of interest highlighted by AssistDent can be used as one element of the overall clinical information gathered when making a decision to diagnose caries.
The software may highlight regions that are not caries, and it is the dentist’s final decision whether these should be investigated further. AssistDent is not guaranteed to find all caries. It is the responsibility of the dentist to investigate areas where no regions of interest are highlighted. The software may mislabel teeth and it is the dentist’s duty to verify that the correct teeth are treated.
Angel Investors
The Northern Powerhouse Investment Fund and The University of Manchester, the company has strong financial backing from institutional investors Mercia Asset Management and Catapult Ventures.
AssistDent® is a registered trademark of Manchester Imaging Limited in Australia, Canada, European Union, New Zealand, United Kingdom, United States of America.