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Impression Material For Fabrication Of Patient-Matched Mouthguards, Over-The-Counter

FDA product code SHI · 3 cleared devices

Class 2 Dental
Regulation
21 CFR 872.3660
Review panel
DE
Implant
No
Life sustaining
No
Third party review
No
GMP exempt
No
Clearance span
2026-02-25 – 2026-09-16

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.

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