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510(k) K925404

CLEARFIL PORCELAIN BOND ACTIVATOR by Kuraray Co. — Product Code KLE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 11, 1993
Date Received
October 23, 1992
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Agent, Tooth Bonding, Resin
Device Class
Class II
Regulation Number
872.3200
Review Panel
DE
Submission Type

Other clearances by Kuraray Co.

  • K990040 — CLEARFIL SE BOND (February 4, 1999)
  • K951813 — CARIES DETECTOR (July 11, 1995)
  • K933030 — PANAVIA 21 (February 24, 1994)
  • K925383 — PHOTO CLEARFIL OPAQUER (January 28, 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)
  • K890123 — CLEARFIL CR INLAY (March 31, 1989)

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