Home / 510(k) Clearances / K911118

510(k) K911118

DTF-1000LL,DTF-1000 by Cp Medical — Product Code EIB

K911118 is an FDA 510(k) premarket notification submitted by Cp Medical for the device "DTF-1000LL,DTF-1000". The FDA issued a decision of Substantially Equivalent on November 20, 1991. The device falls under product code EIB (Syringe, Irrigating (Dental)), a Class I device regulated under 21 CFR 872.4565. Cp Medical has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 20, 1991
Date Received
March 12, 1991
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Syringe, Irrigating (Dental)
Device Class
Class I
Regulation Number
872.4565
Review Panel
DE
Submission Type

Other clearances by Cp Medical

  • K173922 — C-PTFETM Surgical Suture (March 26, 2018)
  • K094028 — CP-FIBER (ORTHOFIBER) (March 18, 2010)
  • K072229 — MONOSWIFT (October 5, 2007)
  • K071550 — PRE-WAXED NEEDLES WITH GOLD FIDUCIARY MARKERS (July 18, 2007)
  • K060987 — OSCERA7 SYNTHETIC ABSORBABLE BONE WAX, MODEL OS31 (November 2, 2006)
  • K041894 — ORTHOFIBER (September 17, 2004)
  • K034062 — CP SLEEVE AND RIVER SLEEVE (January 30, 2004)
  • K024372 — CP MEDICAL BONE WAX (June 19, 2003)
  • K030786 — MONO-SWIFT (May 6, 2003)
  • K030351 — STAINLESS STEEL SURGICAL SUTURE, NON-ABSORBABLE (March 28, 2003)

Other clearances for product code EIB

  • K874543 — MODEL OPO-32 IRRIGATION SLEEVE (January 14, 1988)
  • K822411 — SYSTEM 80 FACEPLATE-IN-THE-EAR #F1 (July 12, 1983)
  • K760570 — ROBINSON MIDDLE EAR PROSTHESIS (September 21, 1976)

FDA data resources