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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Powder, Porcelain
510(k) Number K260918
Device Name Zolid Lunaris
Applicant
Amann Girrbach AG
Gewerbestrasse 10
Maeder,  AT 6841
Applicant Contact Lisa Fassing
Correspondent
Pure Global
111 Town Sq. Pl.
Suite 1203
Jersey City,  NJ  07310
Correspondent Contact Oliver Eikenberg
Regulation Number872.6660
Classification Product Code
EIH  
Date Received03/19/2026
Decision Date 06/29/2026
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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