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510(k) K090597

FLUORILAQ SODIUM FLUORIDE CAVITY VARNISH by Pascal Co., Inc. — Product Code LBH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 16, 2009
Date Received
March 5, 2009
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Varnish, Cavity
Device Class
Class II
Regulation Number
872.3260
Review Panel
DE
Submission Type

Other clearances by Pascal Co., Inc.

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  • K012889 — BANICIDE LIQUID CHEMICAL STERILANT/HIGH-LEVEL DISINFECTANT (May 27, 2003)
  • K030488 — FLUORILAQ (May 2, 2003)
  • K912632 — OCCLUDE (January 17, 1992)
  • K911259 — HYDENT (June 6, 1991)

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