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510(k) K890123

CLEARFIL CR INLAY by Kuraray Co. — Product Code EBF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 31, 1989
Date Received
January 11, 1989
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

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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  • K925404 — CLEARFIL PORCELAIN BOND ACTIVATOR (January 11, 1993)
  • K912707 — CLEARFIL LINER BOND SYSTEM (August 20, 1991)
  • K912708 — CLEARFIL PHOTO ANTERIOR & LINER BOND SYSTEM (August 20, 1991)
  • K910424 — TEETHMATE-F (April 3, 1991)
  • K900690 — CLEARFIL VENEER BOND KIT (April 13, 1990)
  • K897027 — TEETHMATE-A (March 14, 1990)

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