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Identifying counterfeit and non-compliant dental devices

There are a number of possible questions the dentist can consider to help identify equipment which is suspected as fake or substandard:

  • Did you pay a price that was drastically out of line with the normal price for the product?;
  • Did you buy it through an internet dealer or supplier that you didn’t know?;
  • Compare it with a similar product you know to be genuine;
  • Check the weight – copies made with cheap alloy are often much lighter;
  • Finish – there may be rough edges or poor-quality laser etching;
  • Check the company and product name and logo – are they exactly as they should be?  Copies may have small but important differences, or even mistakes;
  • Is the colour and design of the packaging exactly like the genuine product?;
  • In use – some substandard hand instruments have bent or even broken when put under some pressure;
  • The charging/power plug – it must be supplied with a NZ plug, not a Chinese or European plus with adapter – otherwise it is non-compliant;
  • Look at the CE mark – there usually is one, but can you be sure it is genuine, or even the correct one?;
  • The paperwork – if it is in a huge number of languages, including Chinese, this can be a clue that it is a copy.  Devices will also generally need instructions in English;
  • If in doubt, contact the manufacturer.  Genuine products can be tracked back through the chair of supply to confirm their authenticity.

Device Type

Potential Problem/Faults

Potential Risk

Handpiece

Excessive vibration

Bearing failure

Turbine failure

Disintegration

Ineffective in use

Patient injury

User injury

Curing light

Incorrect light emission

Incorrect timer

Dangerous charger

Electric shock (charger)

Ineffective curing

Bur

Failure in use

Ineffective action

Breaking in the mouth

Ineffective in sue

Patient injury – swallowing or inhaling fragments

User injury

Endodontic file

Failure in use

Ineffective action

Ineffective in use

Patient injury

User injury

X-ray devices

Exposure to radiation

Ineffective action

Faulty electrical system

Ineffective in use

Patient injury

User injury

Danger of electric shock

Exposure to radiation

Table 1. Table summarizing potential risks form counterfeit and non-compliant dental devices. (Source: BDIA, Dental Update, May 2016, Vol 43, No.4


Please report any counterfeit or sub-standard product to Medsafe www.medsafe.govt.nz

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