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Multi-Layer Mastery, Where Efficacy Meets Comfort

MOLEKUR™ Pro S:Volume Leader for Clinical Excellence

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Qualification

Quality & Regulatory Compliance

We have set up our own quality management system according to GMP regulations, and have been granted ISO13485:2016 and ISO9001:2015 certificates. Our MOLEKUR™ Series Clear Aligner Materials have been tested and certified by authoritative third-party institutes and have obtained NMPA, FDA, CE and other medical device registrations in many countries and regions.

  • ISO certification mark
  • NMPA medical device registration mark
  • FDA registration mark
  • CE certification mark