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510(k) K863638

GUTTA PERCHA POINTS by Endodent, Inc. — Product Code EKM

K863638 is an FDA 510(k) premarket notification submitted by Endodent, Inc. for the device "GUTTA PERCHA POINTS". The FDA issued a decision of Substantially Equivalent on October 30, 1986. The device falls under product code EKM (Gutta-Percha), a Class I device regulated under 21 CFR 872.3850. Endodent, Inc. has at least 2 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 30, 1986
Date Received
September 17, 1986
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 Endodent, Inc.

  • K863411 — GUTTA PERCHA (October 30, 1986)
  • K830814 — POINT, PAPER ENDODONTIC (April 6, 1983)

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