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510(k) K253513

MultiMatch Flow Chameleon AntiMicrobial Composite by Premier Dental Products Company — Product Code EBF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 7, 2025
Date Received
November 6, 2025
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

Other clearances by Premier Dental Products Company

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  • K141839 — PREMIER ETCH (November 17, 2014)
  • K132526 — KNIT-PAK+ (November 26, 2013)
  • K131212 — PREMIER CERAMIC PRIMER (August 26, 2013)
  • 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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  • K252465 — Any-Core (December 5, 2025)
  • K253236 — G-BLOCK (September 29, 2025)
  • K253053 — Dura-Crown (CB21-A1/CB21-A2/CB21-A3/CB21-B1) (September 23, 2025)
  • K251946 — G aenial Universal Injectable II (August 29, 2025)
  • K251283 — Once-Fil Flow (June 6, 2025)
  • K250317 — EsFlow PLUS (May 30, 2025)
  • K251578 — BEAUTIFIL II (May 27, 2025)