Perfection Plus

Perfection Plus specialises in dental hygiene and diagnostic devices. Their portfolio includes fluoride-releasing mouthwash tablets, dental dams, prophylaxis pastes for cleaning and cavity prevention, intraoral radiography systems like the PFI and Orbis for dental X-rays, and dental impression materials such as ImpressPLUS for creating molds of teeth and gums. These products focus on oral health maintenance and diagnostic imaging.

Perfection Plus is based in the United Kingdom. Since they manufacture devices intended for the EU market, their products must comply with European medical device regulations. The company registers its devices in the EU’s eudamed database, which is mandatory for manufacturers placing medical devices on the market within the European Economic Area. Compliance with EU directives ensures their devices meet safety, performance, and regulatory requirements.

Perfection Plus’s devices are classified under EU regulations as either Class I or Class IIa. Class I devices generally pose minimal risk and may require basic conformity assessment procedures, while Class IIa devices involve moderate risk and require additional scrutiny, such as clinical evaluations or designated body involvement. The classification depends on factors like the device’s intended use, duration of contact with the body, and potential risks.

Yes, all of Perfection Plus’s devices are registered in eudamed, the EU’s centralised database for medical devices. This registry is required for manufacturers placing devices on the EU market to demonstrate compliance with EU regulations. Listing in eudamed ensures transparency, allows healthcare professionals and regulators to verify device details, and supports traceability for post-market surveillance. It is a key requirement for legal market placement under EU medical device legislation.

The intraoral radiography devices from Perfection Plus, such as the PFI and Orbis systems, fall under Class IIa classification. This classification reflects their role in capturing X-rays, which involves exposure to ionising radiation—a moderate risk requiring controlled use. Class IIa devices undergo additional conformity assessment procedures, including clinical performance evaluations and involvement of a Notified Body, to ensure they meet safety and effectiveness standards before being placed on the market.