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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 K253191
Device Name DCMhotbond zircon
Applicant
Dental Creativ Management GmbH
Breite St. 16
18055, Rostock,
Mecklenburg-Vorpommerin,  DE
Applicant Contact Milija Mitrovic
Correspondent
Trisler Consulting (Dba)
306 Turnberry Ct.
Lebanon,  IN  46052
Correspondent Contact Patsy Trisler
Regulation Number872.6660
Classification Product Code
EIH  
Date Received09/26/2025
Decision Date 05/21/2026
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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