Mask Fitter by Bellus3D

Model Description

Model ID
3DPX-013836
Category Labware & Devices
Device Use
General Equipment or Adapter
Keyword(s) 3D Printed Face Mask
Bellus3D's Face Mask Fitter is a plastic frame that helps to improve the seal with surgical masks or similar face masks. It is made using a Bellus3D face scan (created with the Bellus3D FaceApp) and a 3D printer to precisely fit a person's facial geometry.

Attached is one example that fits about 15% of the population. You can download the Bellus3D FaceApp (https://apps.apple.com/us/app/bellus3d-faceapp/id1352268131), scan your face and output a personalized STL to use on your 3D printer. You don't need to create an account or pay to make your own, personalized Mask Fitter.

Mask Fitter is a personalized device intended for use by individuals. More information can be found here: https://bellus3d.com/solutions/facemask.html

Attribution Instructions:
By Bellus3D, Inc. https://bellus3d.com/solutions/facemask.html


Reviewer Notes






The following refers to: 3dpx-013836

The FDA has authorized production of face mask outside of the normal clearance pathway during the Covid-19 pandemic, based on Part 5, section D of the “Enforcement Policy for Face Masks and Respirators During the Coronavirus Disease (COVID-19) Public Health Emergency Guidance for Industry and Food and Drug Administration Staff.”

This face mask has undergone review in a clinical setting and is recommended when fabricated as instructed.

RESOLVED:

05.02.20 For documentation purposes, we cannot accept links to external websites for printing instructions, instructions for use, etc. Instructions need to be included as a PDF or as text on the NIH 3D Print Exchange website.

Files

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TDP Category Type Filename Size
General Instructions application/pdf How to Make Bellus3D_s Face Mask Fitter.pdf 628.28 KB
STL File Bellus3Dcontour5C_0.stl 534.65 KB
Blender-generated-x3d Bellus3Dcontour5C_0.stl60c12bbaac4f9.x3d 353.15 KB

Zip


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Part Information

Additional Owner's Names

tspurgeon

AMCPR Type

designPackage

Model Number

3DPX-012836

Review Process

simple

Public

Yes
2021-06-09T20:57:51

Materials

Polymer

AM Process

Unknown / Multiple

Quality Standards

Submission Path

production

Assembly Required

No
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