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510(k) K862129

SET CANAL SEALER PASTE by Endo Technic Corp. — Product Code EKM

K862129 is an FDA 510(k) premarket notification submitted by Endo Technic Corp. for the device "SET CANAL SEALER PASTE". The FDA issued a decision of Substantially Equivalent on July 22, 1986. The device falls under product code EKM (Gutta-Percha), a Class I device regulated under 21 CFR 872.3850. Endo Technic Corp. has at least 9 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 22, 1986
Date Received
June 4, 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 Endo Technic Corp.

  • K990908 — MILLENNIUM (May 27, 1999)
  • K971459 — DERMALASE (July 18, 1997)
  • K925079 — LAPAROSCOPIC INST. (SCISSORS,FORCEPS,NEEDLEHOLDER) (August 24, 1994)
  • K930756 — LAPAROSCOPIC IRRIGATION/ASPIRATION HANDPIECE (March 9, 1994)
  • K925114 — LAPAROSCOPIC INSTRUMENTS (February 28, 1994)
  • K924058 — TROCAR (March 30, 1993)
  • K914825 — 1-125 ENDOSEED (March 19, 1992)
  • K910200 — LASER-35 (May 9, 1991)
  • K864976 — SOLUSET CALCIUM DEMINERALIZING SOLUTION (February 27, 1987)

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