Zakresy certyfikatu

• EN ISO 13485
  

  Design and development, manufacture, distribution and warehousing of products related to dental implantology

• MDD Annex II excl. 4
  

  Products related to dental implantology

  Products included:

  - Dental Implants
  - Dental Abutments
  - Dental Drills
  - Healing Caps, dental
  - Cover Screws, dental
  - Instruments, dental

  For the following devices the scope covers only the aspects of the manufacture concerned with the securing and maintaining sterile conditions:

  - Instruments for dental impression

• MDR Ann. IX, Chapt I
  

  Products of Class llb:
  Odontological Prostheses
  - P010201 - Dental Implants and Accessories

  Products of class I, sterile:
  - Q010207 - Dental Impression Devices for Prosthetic Dentistry

  The scope of certification is limited to the aspects relating to establishing, securing and maintaining sterile conditions