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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Dental Barriers And Sleeves
510(k) Number K261956
Device Name Dental Barriers and Sleeves (AB0006)
Applicant
ANI Co., Ltd.
4f, Bldg. B
182, Saneop-Ro 156beon-Gil
Suwon-Si, Gyeonggi-Do,  KR 16648
Applicant Contact Seongcheol Kim
Correspondent
JNM KOREA CO.,Ltd
206, 207, 306, Gunpo-It Valley
17 Gosan-Ro 14beon-Gil
Gunpo-Si, Gyeonggi-Do,  KR 15850
Correspondent Contact Bobae Jung
Regulation Number878.4370
Classification Product Code
PEM  
Date Received06/11/2026
Decision Date 09/08/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel Dental
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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