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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Plate, Bone
510(k) Number K253206
Device Name METICULY Patient-specific CMF solution
Applicant
Meticuly Co., Ltd.
924 B Bldg., Rm. B116-118, B210-212
Soi Chula 7, Wang Mai, Pathum Wan
Bangkok,  TH 10330
Applicant Contact Lohwongwatana Peeranoot
Correspondent
Mdr Solutions Co., Ltd.
1435 Kanjanapisek Rd.
Bang Khae Nuea, Bang Khae
Bangkok,  TH 10160
Correspondent Contact Paweena U-Thainual
Regulation Number872.4760
Classification Product Code
JEY  
Subsequent Product Codes
DZJ   LLZ  
Date Received09/26/2025
Decision Date 07/25/2026
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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