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510(k) K897027

TEETHMATE-A by Kuraray Co. — Product Code EBC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 14, 1990
Date Received
December 18, 1989
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Sealant, Pit And Fissure, And Conditioner
Device Class
Class II
Regulation Number
872.3765
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)
  • 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)
  • K890123 — CLEARFIL CR INLAY (March 31, 1989)

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