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510(k) K023819

FIBERFILL SGP by Pentron Clinical Technologies — Product Code EKM

K023819 is an FDA 510(k) premarket notification submitted by Pentron Clinical Technologies for the device "FIBERFILL SGP". The FDA issued a decision of Substantially Equivalent on March 26, 2003. The device falls under product code EKM (Gutta-Percha), a Class I device regulated under 21 CFR 872.3850. Pentron Clinical Technologies has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 26, 2003
Date Received
November 15, 2002
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 Pentron Clinical Technologies

  • K091512 — BUILD-IT LIGHT CURE (October 30, 2009)
  • K081887 — LUTE-IT II VENEER CEMENT, MODEL NO6 (August 29, 2008)
  • K072830 — RM BOND, MODEL J032 (December 4, 2007)
  • K072480 — GENERATION 8 SE ADHESIVE (November 21, 2007)
  • K072545 — ARTISTE SE FLOWABLE COMPOSITE, MODEL N280 (October 26, 2007)
  • K071500 — NANO-BOND II ADHESIVE SYSTEM (August 10, 2007)
  • K060889 — SE EPIPHANY ROOT CANAL SEALANT, MODEL N59SE (October 27, 2006)
  • K060698 — CEMENT-IT ALL PURPOSE, MODEL N97 (May 10, 2006)
  • K052106 — SIMILE FLOW (October 31, 2005)
  • K052349 — AVANTE LED CURING UNIT, MODEL N44 (October 21, 2005)

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)
  • K971641 — ANTIBACTERIAL GUTTA PERCHA (July 21, 1997)
  • K970134 — THERMAPREP PLUS OVEN (March 21, 1997)
  • K931742 — INJECT-R FILL (May 27, 1993)
  • K924825 — MICRODOSE RC-EZ (March 5, 1993)
  • K915243 — TOUCH 'N HEAT MODEL 5002, MODIFICATION (January 21, 1992)
  • K910224 — THERMAPREP (March 29, 1991)

FDA data resources