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EN ISO 13485
Design and development, manufacture, distribution and warehousing of products related to dental implantology
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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
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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
