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510(k) K925163

MICODOSE CHLORHEXIPREP by Unicep — Product Code ECM

K925163 is an FDA 510(k) premarket notification submitted by Unicep for the device "MICODOSE CHLORHEXIPREP". The FDA issued a decision of Substantially Equivalent on May 27, 1993. The device falls under product code ECM (Band, Preformed, Orthodontic), a Class I device regulated under 21 CFR 872.5410. Unicep has at least 8 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 27, 1993
Date Received
October 13, 1992
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Band, Preformed, Orthodontic
Device Class
Class I
Regulation Number
872.5410
Review Panel
DE
Submission Type

Other clearances by Unicep

  • K924824 — MICRODOSE PIT AND FISSURE SEALANT-CLEAR OR WHITE (March 16, 1993)
  • K924823 — MICRODOSE SILANE (March 16, 1993)
  • K925162 — MICRODOSE DENTIN CONDITIONER (March 16, 1993)
  • K924821 — MICRODOSE PORCELAIN ETCHANT (March 16, 1993)
  • K924827 — MICRODOSE POTASSIUM OXYLATE (March 5, 1993)
  • K924822 — MICRODOSE ENAMEL ETCHANT (March 5, 1993)
  • K924825 — MICRODOSE RC-EZ (March 5, 1993)
  • K924826 — MICRODOSE TOTAL ETCHANT (March 5, 1993)

Other clearances for product code ECM

  • K872471 — TITANE SL DENTAL BURR (September 11, 1987)

FDA data resources