Inman Digital Clear Aligners

Aligner, Sequential

Inman Orthodontic Laboratories, Inc.

The following data is part of a premarket notification filed by Inman Orthodontic Laboratories, Inc. with the FDA for Inman Digital Clear Aligners.

Pre-market Notification Details

Device IDK210763
510k NumberK210763
Device Name:Inman Digital Clear Aligners
ClassificationAligner, Sequential
Applicant Inman Orthodontic Laboratories, Inc. 3953 NW 126th Avenue Coral Springs,  FL  33065
ContactDonal P. Inman
CorrespondentPatsy J. Trisler
Trisler Consulting 7949 Beaumont Green East Drive Indianapolis,  IN  46250
Product CodeNXC  
CFR Regulation Number872.5470 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-03-15
Decision Date2021-09-29

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