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510(k) K924827

MICRODOSE POTASSIUM OXYLATE by Unicep — Product Code LBH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 5, 1993
Date Received
September 28, 1992
Clearance Type
Traditional
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 Unicep

  • K925163 — MICODOSE CHLORHEXIPREP (May 27, 1993)
  • K924821 — MICRODOSE PORCELAIN ETCHANT (March 16, 1993)
  • K924823 — MICRODOSE SILANE (March 16, 1993)
  • K925162 — MICRODOSE DENTIN CONDITIONER (March 16, 1993)
  • K924824 — MICRODOSE PIT AND FISSURE SEALANT-CLEAR OR WHITE (March 16, 1993)
  • K924826 — MICRODOSE TOTAL ETCHANT (March 5, 1993)
  • K924825 — MICRODOSE RC-EZ (March 5, 1993)
  • K924822 — MICRODOSE ENAMEL ETCHANT (March 5, 1993)

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