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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Material, Tooth Shade, Resin
510(k) Number K222583
Device Name Stela Capsule System
Applicant
Sdi Limited
3-15 Brunsdon St., Bayswater
Melbourne,  AU 3153
Applicant Contact Quynh Jewell
Correspondent
Sdi Limited
3-15 Brunsdon St., Bayswater
Melbourne,  AU 3153
Correspondent Contact Quynh Jewell
Regulation Number872.3690
Classification Product Code
EBF  
Subsequent Product Code
KLE  
Date Received08/26/2022
Decision Date 10/28/2022
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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