Summary of Safety and Clinical Performance (SSCP)

The SSCP is intended to provide public access to an updated summary of clinical data and other information about the safety, risks, benefits, and clinical performance of implantable medical devices and Class III medical devices.Please note, the SSCP is not intended to give general advice on the diagnosis or treatment of a particular medical condition.

On this page you may request access to the SSCP documents prepared for the medical devices manufactured by B.J.M. Laboratories which are classified as “Implantable” according to Regulation (EU) 2017/745, otherwise referred to as MDR.

Risk Class of the Medical Device: IIa.
Classification System: Classification Rule 8 in Annex VIII, Chapter III of the Regulation (EU) 2017/745.
Applicable Codes for Classification: MDN 1103, MDT 2006, MDT 2011 of the Regulation (EU) 2017/2185.

SSCP documents are available for the following medical devices:
o Bonding Agents: Prima 2000, Prima Quick (Prime and Bond), Auto-Cure Activator.
o Endodontics: Root Canal Sealer.
o Glass Ionomer Cements: Q-Glass.
o Permanent Adhesive Resin Cements: High-Q-Bond, High-Q-Bond SE, Zirconite.
o Core Build Up Restoratives: Q-Core.
o Long Term Temporary Resin Cement: Q-Temp.

Please note that the SSCP documents will only be made available here temporarily until such a time that the EUDAMED system is fully operational, upon which, all access to the files will be granted through EUDAMED.
Furthermore, please consider that, although available to the public in general, due to all medical devices manufactured by B.J.M. Laboratories being made for use by dental professionals only, the SSCP documents provided are specifically targeted towards those professionals and are not applicable to the patient.

If you would like access to the SSCP documents, please fill in this application here.
You will be sent a one-time password for access to the files within 5 business days.
Please note, if not used, the password will expire within 24 hours.