Home / 510(k) Clearances / K030605

510(k) K030605

RAPID IMF by Zygomatics , Ltd. — Product Code DYX

K030605 is an FDA 510(k) premarket notification submitted by Zygomatics , Ltd. for the device "RAPID IMF". The FDA issued a decision of Substantially Equivalent on June 27, 2003. The device falls under product code DYX (Lock, Wire, And Ligature, Intraoral), a Class II device regulated under 21 CFR 872.4600.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 27, 2003
Date Received
February 25, 2003
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Lock, Wire, And Ligature, Intraoral
Device Class
Class II
Regulation Number
872.4600
Review Panel
DE
Submission Type

Other clearances for product code DYX

  • K162046 — MINNE TIES MMF Suture System (April 11, 2017)
  • K061271 — ERCH ARCH BAR, MODEL 38-690-00 (June 30, 2006)
  • K031207 — SAFETY RELEASE ARCH BAR KIT (July 15, 2003)
  • K990212 — LOCKJAW 15 MINUTE INTERMAXILLARY FIXATION SYSTEM,MODEL LJ100-00 (September 14, 1999)
  • K991004 — SYNTHES QUICK LOCK IMF SYSTEM (June 23, 1999)
  • K925106 — IMPLANTABLE PULSE GENERATORS (October 6, 1993)
  • K925712 — RELIANCE SHORT STICK TIE (January 11, 1993)
  • K910090 — DIMAC WIRES (July 25, 1991)
  • K863799 — JAW FIXATION ASSEMBLY (October 14, 1986)
  • K820944 — DENTAL ARCH BAR (May 5, 1982)

FDA data resources