Impression Material For Fabrication Of Patient-Matched Mouthguards, Over-The-Counter
SHI · Class II — Moderate Risk (510(k) clearance required) · Dental · 21 CFR 872.3660
Classification
FDA Product Code
SHI
Device class
Class II — Moderate Risk (510(k) clearance required)
Regulation
21 CFR 872.3660
Review panel
DE
Medical specialty
Dental
Submission type
1
GMP exempt
N
Life sustaining
N
Implant
N
Third-party review
N
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.