The Medicines and Healthcare products Regulatory Agency (MHRA) is warning dentists about the potential danger of buying and using counterfeit and unapproved dental equipment. This follows the seizure of over 12,000 different pieces of poor quality dental equipment imported into the UK from China and Pakistan and sold on auction websites such as eBay, Amazon and Alibaba in the past 6 months.

The MHRA – the UK’s regulator for medical devices and medicines – has six ongoing investigations involving the purchase of counterfeit and unapproved dental equipment such as high-speed hand piece drills from auction websites by UK dentists. The seized items include:

24 dental x-ray machines that emit high levels of radiation

384 hand-piece drills that could malfunction and disintegrate inside patient’s mouths

3,242 poor quality root canal files that could break

While there is no evidence to suggest that buying equipment from auction websites is a widespread or deliberate practice among dentists, the MHRA is concerned about the growing range of dental equipment that is being advertised to dentists at cheap prices, both online and at dental trade fairs in China.

The MHRA issued a safety alert to all dentistry professionals in January 2014, following an incident in November 2013 when a counterfeit product for drilling and cleaning teeth shattered while being used on a patient. The patient was unharmed but the MHRA aims to raise awareness among dentistry professionals so that other patients are not put at risk.

Alastair Jeffrey, the MHRA's Head of Enforcement, said:

“Dentists must source their dental equipment from reputable suppliers. Purchasing from auction websites and being unable to verify the integrity of the seller has the potential to increase risks to patients and cause reputational damage to the dental profession.

“The MHRA has seized large amounts of cheaply-priced, counterfeit and unapproved dental equipment. This equipment looks like the genuine product, and often has false CE approval markings but it is potentially dangerous to patients and the dental staff using it.

“We are working with the British Dental Industry Association, the British Dental Association, eBay, Amazon and other auction websites to tackle this problem and remove the advertisements for this equipment. Dentists or members of the public can contact the MHRA if they suspect that they may have information about counterfeit or unapproved dental equipment through our Adverse Incident Centre at This e-mail address is being protected from spambots. You need JavaScript enabled to view it or 020 3080 7080.”

Tony Reed, British Dental Industry Association’s Executive Director, said: “We are delighted to be working closely with the MHRA to raise awareness of counterfeit and non-compliant products through our Counterfeit and Substandard Instruments and Devices Initiative (CSIDI).”

Dr Barry Cockcroft, NHS England’s Chief Dental Officer said, “This is important work by the MHRA. It is imperative for patient safety that dentists do not purchase equipment, from any source where they cannot be confident of the origin or quality.”

Notes to Editor

1. The MHRA has seized over 12,000 individual pieces of counterfeit and non-approved dental equipment since April this year. About 40 per cent are counterfeit and 60 per cent are non-compliant with European medical device regulations. Below is a breakdown of the items of equipment the MHRA has seized:

Equipment classed as a Class 3 high-risk medical device:
24 Dental X-ray machines that emit cancer-causing radiation
Equipment classed as a Class 2A medium-risk medical device

3242 root canal files
683 dental curing lights
384 Hand piece drills including fast drills (184 counterfeit, 200 non-compliant)
37 Air Motors,
14 Air syringes

Equipment classed as a Class 1 low-risk medical device:

7638 including dental scalers, wax carving sets, retractors, prophy powder, autoclaves, intra oral tips, microbrushes, mixing tips, face masks, surgical gloves, saliva injectors, sterile Indicator strips, amalgamators, micro brushes, scaler tips, apex locators, prophy brushes

2. The MHRA showcased this equipment at the British Dental Industry Association’s Dental Showcase exhibition in London in October 2014. Photographs are available on request.

3. The MHRA’s Medical Device Alert to dentistry professionals in January 2014 can be viewed here

4. The British Dental Industry Association’s initiative to promote awareness about counterfeit and unapproved dental equipment can be viewed here (external link)

5. The MHRA is responsible for regulating all medicines and medical devices in the UK by ensuring they work and are as safe as is reasonably possible. Underpinning all our work is strong and evidence-based judgements to ensure that the benefits justify any risks. The MHRA is a centre of the Medicines and Healthcare Products Regulatory Agency which also includes the National Institute for Biological Standards and Control (NIBSC) and the Clinical Practice Research Datalink (CPRD). The MHRA is an executive agency of the Department of Health.