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510(k) K223632

Premier's MultiMatch Universal Chameleon Restorative Composite by Premier Dental Products Company — Product Code EBF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 6, 2022
Date Received
December 5, 2022
Clearance Type
Traditional
Expedited Review
No
Third Party Review
Yes

Device Classification

Device Name
Material, Tooth Shade, Resin
Device Class
Class II
Regulation Number
872.3690
Review Panel
DE
Submission Type

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  • K132526 — KNIT-PAK+ (November 26, 2013)
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  • K083695 — TRAXODENT (April 28, 2009)
  • K062683 — ENAMEL PRO VARNISH (November 21, 2006)
  • K062166 — ENAMEL PRO (November 21, 2006)
  • K061998 — PREMIER SELF-ETCHING BOND ENHANCER (October 4, 2006)
  • K061997 — PREMIER SELF-ETCHING ENAMEL SEALANT (October 4, 2006)

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