- MEDIUM
- Industry
- Tier 2
- Clinical & Visual
Graphy Completes EU Medical Device Review for 3D Printing Materials
- Source
- Orthodontic Products
- Author
- OP Edit Staff
- Originally at
- orthodonticproductsonline.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 Inc completed the final conformity assessment review for five dental 3D printing materials under the EU Medical Device Regulation and now awaits certificates.
Key points
- 01
Graphy Inc completed the final conformity assessment review for five dental 3D printing materials under the EU Medical Device Regulation.
- 02
The five materials are TeraHarz Clear TC-85DAC, TA-28, TR-07, TeraHarz TC-80DC, and BR-23.
- 03
Graphy Inc holds prior US FDA 510(k) clearance and Brazil ANVISA registration for its dental materials.
- 04
Graphy Inc plans to use the EU certification to expand local manufacturing and distribution partnerships in Europe.
Who should care
- Owner
- Specialist
Read the original
Orthodontic Products
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