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Graphy Completes EU MDR Review for Five Dental 3D Printing Materials
- Source
- Dentistry Today
- Author
- Dentistry Today
- Originally at
- dentistrytoday.com(opens in a new tab)
Summary and scoring by The Bell Brief (Dr. Jennifer Bell) using the Drill-Down Protocol. Not the original publisher.
Why it matters for dental
Graphy’s EU MDR certification for five dental 3D printing materials supports material supply and local manufacturing partnerships for European dental partners.
Key points
- 01
Graphy completed the final conformity assessment review for three TeraHarz Clear products (TC-85DAC, TA-28, TR-07) and two TeraHarz products (TC-80DC, BR-23) under Regulation (EU) 2017/745.
- 02
Graphy is awaiting issuance of the certificates after completing the final conformity assessment review.
- 03
Graphy plans to expand European manufacturing and distribution partnerships, including a collaboration with Smilers, the clear aligner brand of France-based Biotech Dental.
- 04
Graphy already holds U.S. FDA 510(k) clearance and Brazil ANVISA registration and is now using the EU MDR review to strengthen materials supply in Europe.
Who should care
- Owner
- DSO
Read the original
Dentistry Today
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