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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 K242892
Device Name Cristaline Aligners Z FLX
Applicant
Cristaline Aligners GmbH
Hanauer Strasse 1-5
Pforzheim,  DE 75181
Applicant Contact Boris Simnovski
Correspondent
Trisler Consulting (dba)
306 Turnberry Court
Lebanon,  IN  46052
Correspondent Contact Patsy Trisler
Regulation Number872.5470
Classification Product Code
NXC  
Date Received09/23/2024
Decision Date 12/19/2024
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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