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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 K223632
Device Name Premier's MultiMatch Universal Chameleon Restorative Composite
Applicant
Premier Dental Products Company
1710 Romano Drive
Plymouth Meeting,  PA  19462 -4500
Applicant Contact Jessica Huang
Correspondent
REGULATORY TECHNOLOGY SERVICES, LLC
1000 Westgate Drive,
Suite 510k
Saint Paul,  MN  55114
Correspondent Contact Prithul Bom
Regulation Number872.3690
Classification Product Code
EBF  
Date Received12/05/2022
Decision Date 12/06/2022
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
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