Quality

Quality and excellence in our products is vital to IPD. We operate with strict quality controls to obtain functional products that comply with market expectations. The following certificates show our commitment:

• ISO 9001 - Quality Management System Certification.
• ISO 13485 - Quality Management System Certification.
• CE Mark.
• Medical Device Single Audit Program (MDSAP) - Certification.

IPD also operates in the following markets:

•  USA 
  IPD is registered in the FDA’s Establishment and Device Listing database, with Registration Number 3016954909.
• Canada
  IPD has the Medical Device Establishment Licence from Health Canada, MDEL No. 18296.

The FDA currently requires milling centers, especially those serving as finished abutment manufacturers, to have a valid Establishment Registration and maintain a consistent Quality Management System to qualify as a Validated Milling Center (VMC). IPD is supporting its partners in navigating these requirements. Since July 2022, our 510(k)-Class II devices fall under product codes NHA & PNP, validating the digital dentistry workflow and simplifying compliance. By utilizing our prosthetic components and following our CAD-CAM design parameters and recommendations, milling centers are not required to become a VMC, avoiding associated implications.