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Dental Tribune United Kingdom Edition

I am sure there are many dental practices and labo- ratories out there scratch- ing their heads in wonderment with regards to the Medical De- vice Directives, which has been a legal requirement for dentists since March 2010, and covers a vast amount of dental and med- ical materials used on patients. A statement of manufacture is a prescription of the device that has been prescribed, who it was prescribed by, and what the product is. It informs the patient of the manufacturer and the materials used. It also states standard after care advice of how to care for the device that has been prescribed and issued. Barrage of questions Our group dental arts studio is made up of six practices and we use many different laboratories so when this task was set before me I knew it would take some organisation, however I was unprepared for the barrage of questions that came flowing in from many of the labs. Due to my frustration at what should have been a simple task I did some research and made a couple of phone calls to find out that I was not the only person who was struggling to make some sense of the Medi- cal Device Directive. As this is a legal require- ment it concerned me, and I wanted to implement it as soon as possible to avoid any future repercussions. What I under- stood was that it was the den- tist’s responsibility to liaise with their lab with regards to the statement of manufac- ture, which must be supplied with all laboratory work that gets placed into our patient’s mouths. Changes have been made to this Medical Device Directive 93/42/EC to improve the standard of appliances pro- vided to patients to ensure good and ongoing patient care. All dentists were notified about the directive require- ment and made aware of their ‘We are all worms. But I believe that I am a glow-worm’ Sharon Holmes provides some advice on understanding the Medical Device Directive page 10DTà ‘What I understood was that it was the dentist’s responsi- bility to liaise with their lab with re- gards to the state- ment of manufac- ture, which must be supplied with all laboratory work that gets placed into our patient’s mouths’ February 14-20, 20118 Practice Management United Kingdom Edition DECAPINOL® creates an invisible barrier that prevents bacteria from adhering to the tooth surfaces. ■ Clinically effective in prevention against plaque and gingivitis as shown in multiple clinical studies ■ Unlike other dental products DECAPINOL® gently and safely protects against gingivitis ■ Preventative against periodontitis DECAPINOL® promotes a healthy long-term plaque management. ■ Maintains a healthy balanced oral micro flora ■ No semi-permanent staining ■ Minimal alcohol content ■ No interaction with Sodium Lauryl Sulfate (SLS) Start recommending DECAPINOL® Stop plaque coming back! Healthy plaque management DECAPINOL® mouthwash and toothpaste – A new and intelligent way to manage gingivitis and prevent periodontitis. 1-0-2010-8-1-2-1 For more information please contact the customer care line on: +44(0)1483 410600 or email decapinol@sinclairpharma.com or visit www.decapinol.com DECAPINOL® is registered as a Medical Device IIa and patent protected. Sinclair Decapinol Ad 20 08 10 260x179.indd 1 30/9/10 11:06:48