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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
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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