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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name aligner, sequential
510(k) Number K210763
Device Name Inman Digital Clear Aligners
Inman Orthodontic Laboratories, Inc.
3953 NW 126th Avenue
Coral Springs,  FL  33065
Applicant Contact Donal P. Inman
Trisler Consulting
7949 Beaumont Green East Drive
Indianapolis,  IN  46250
Correspondent Contact Patsy J. Trisler
Regulation Number872.5470
Classification Product Code
Date Received03/15/2021
Decision Date 09/29/2021
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No