Impression Material For Fabrication Of Patient-Matched Mouthguards, Over-The-Counter
Medical specialty
Dental
Device class
2
Regulation number
872.3660
Review panel
DE
Implant
N
Life sustaining/supporting
N
GMP exempt
N
Third party review
N
Summary malfunction reporting
Ineligible
Definition
An over-the-counter device that is intended to reproduce the structure of a patient's teeth and gums for the fabrication of patient-matched mouthguards/nightguards.