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510(k) K924825

MICRODOSE RC-EZ by Unicep — Product Code EKM

K924825 is an FDA 510(k) premarket notification submitted by Unicep for the device "MICRODOSE RC-EZ". The FDA issued a decision of Substantially Equivalent on March 5, 1993. The device falls under product code EKM (Gutta-Percha), a Class I device regulated under 21 CFR 872.3850. Unicep has at least 8 other 510(k) clearances on record.

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
Gutta-Percha
Device Class
Class I
Regulation Number
872.3850
Review Panel
DE
Submission Type

Other clearances by Unicep

  • K925163 — MICODOSE CHLORHEXIPREP (May 27, 1993)
  • K924823 — MICRODOSE SILANE (March 16, 1993)
  • K925162 — MICRODOSE DENTIN CONDITIONER (March 16, 1993)
  • K924821 — MICRODOSE PORCELAIN ETCHANT (March 16, 1993)
  • K924824 — MICRODOSE PIT AND FISSURE SEALANT-CLEAR OR WHITE (March 16, 1993)
  • K924827 — MICRODOSE POTASSIUM OXYLATE (March 5, 1993)
  • K924826 — MICRODOSE TOTAL ETCHANT (March 5, 1993)
  • K924822 — MICRODOSE ENAMEL ETCHANT (March 5, 1993)

Other clearances for product code EKM

  • K073369 — EI DOWNPAK BARRIER SLEEVES (February 27, 2008)
  • K070246 — DOWN PAK (February 16, 2007)
  • K051573 — TGP (GUTTA PERCHA CONTAINING TETRACYCLINE OR DOXYCYCLINE) (June 26, 2006)
  • K042870 — ENDO TWINN (January 11, 2005)
  • K023819 — FIBERFILL SGP (March 26, 2003)
  • K971641 — ANTIBACTERIAL GUTTA PERCHA (July 21, 1997)
  • K970134 — THERMAPREP PLUS OVEN (March 21, 1997)
  • K931742 — INJECT-R FILL (May 27, 1993)
  • K915243 — TOUCH 'N HEAT MODEL 5002, MODIFICATION (January 21, 1992)
  • K910224 — THERMAPREP (March 29, 1991)

FDA data resources