Today's splints are devices that can now be manufactured by additive manufacturing (3D printing). There is quite a bit of discussion about splints, biteguards, nightguards, occlusal splints and the dental laboratory's involvement in the manufacturing process. What are the legal obligations for the dental lab if they manufacture a guard with the Verisplint material from Whip Mix or another manufacturer? We hope this webinar will aid dental laboratories in navigating FDA waters for Regulatory Compliance.

 

 

John Waters
Regulatory Compliance Officer | Whip Mix
John Waters is the Regulatory Compliance Officer for Whip Mix Corporation. He has worked in some regulatory capacity for most of his career.  John has spent the last seven years in medical device-related endeavors and because of his first hand FDA experience, he understands Quality System Regulations from the Agency’s perspective. John’s extensive experience with FDA includes areas related to 510 (k) Submissions, Medical Device Reports (MDR reporting), FDA inspections, Warning letter resolution, Device classification and company classification, and many other areas.

 

 

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