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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Orthodontic Software
510(k) Number K262378
Device Name Dr.AlignNavi
Applicant
InnoDtech, Inc.
Rm. 312, Bldg. A, Business Support Center, 123 Cheomdangwagi
Gwangju,  KR 61005
Applicant Contact Hyeon gu Lee
Correspondent
CTNS Corp.
Rm. 1113 And 1114, 2 Nongshim-Ro
Gunpo-Si, Gyeonggi-Do,  KR 14548
Correspondent Contact Eunsol Jung
Regulation Number872.5470
Classification Product Code
PNN  
Subsequent Product Code
LLZ  
Date Received07/13/2026
Decision Date 10/07/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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