Certifications and Patents

Quality and health guaranteed for the patients

Behind every smile made possible by a BTLock implant there is a story to tell, but there are especially many tests, patents and certifications that make it safe and flawless.
After all, the well-being of the patient depends on the quality of the medical device: the care in the manufacture, the reliability of materials, the implants safety and the attention to packaging. All these factors place BTLock International at the top of the production in the dental field.

The quality assurance is one of the essential elements during the study and development of our products, which are made entirely in Italy in accordance with EN ISO 13485.
All BTLock products belonging to Class I feature the CE label, whereas those belonging to Class IIA and IIB are certified by the Istituto Superiore di Sanità (Notifying Body n°0373 – Italian Ministry of Health).
Conforming to the regulation of the Directive 93/42/EEC and Modification 2007/47/ CE, medical devices’ conformity is assessed before entering the market.

Furthermore, the request for international distribution has brought BTLock to conform its production to extra-UE standards in order to obtain the registration in foreign markets such as Taiwan (DOH), Brazil (Anvisa), South Korea (KFDA) and Mexico (Cofepris).
All BTLock’s implants and prosthetic options have also received the FDA long-term approval (K073458 and K083869).

Download our certifications:

Certificato UNI EN ISO 13485
Certificato N. QCT-0064-17
Certificato ANVISA
Certificato DOH
Lettera FDA K083869
Lettera FDA K073458
US Patent
Certificato KFDA
Certificato Cofepris