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510(k) K832654

HEATED GUTTA PERCHA DELIVERY SYSTEM by Unitek Corp. — Product Code EKM

K832654 is an FDA 510(k) premarket notification submitted by Unitek Corp. for the device "HEATED GUTTA PERCHA DELIVERY SYSTEM". The FDA issued a decision of Substantially Equivalent on September 26, 1983. The device falls under product code EKM (Gutta-Percha), a Class I device regulated under 21 CFR 872.3850. Unitek Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 26, 1983
Date Received
August 8, 1983
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 Unitek Corp.

  • K944286 — METAL-LINED TRANSCEND CERAMIC BRACKET (November 29, 1994)
  • K933501 — ALASTIK (April 28, 1994)
  • K940165 — ALASTIK (March 7, 1994)
  • K923999 — ALASTIK NS (June 24, 1993)
  • K924645 — TRANSCEND SERIES 6000 DEBONDING INSTRUMENTS (November 25, 1992)
  • K924295 — DEBRACKETING INSTRUMENT (November 23, 1992)
  • K923432 — GERMAN MINI DYNALOCK (October 30, 1992)
  • K911271 — ADHESIVE PRECOATED BRACKETS (May 29, 1991)
  • K910288 — NONSTAINING ALASTIKS (March 29, 1991)
  • K890529 — ALASTIGARD (March 9, 1989)

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)
  • K924825 — MICRODOSE RC-EZ (March 5, 1993)
  • K915243 — TOUCH 'N HEAT MODEL 5002, MODIFICATION (January 21, 1992)

FDA data resources