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510(k) K990212

LOCKJAW 15 MINUTE INTERMAXILLARY FIXATION SYSTEM,MODEL LJ100-00 by Doctor'S Research Group, Inc. — Product Code DYX

K990212 is an FDA 510(k) premarket notification submitted by Doctor'S Research Group, Inc. for the device "LOCKJAW 15 MINUTE INTERMAXILLARY FIXATION SYSTEM,MODEL LJ100-00". The FDA issued a decision of Substantially Equivalent on September 14, 1999. The device falls under product code DYX (Lock, Wire, And Ligature, Intraoral), a Class II device regulated under 21 CFR 872.4600. Doctor'S Research Group, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 14, 1999
Date Received
January 22, 1999
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 by Doctor'S Research Group, Inc.

  • K051487 — DRG LARYNGEAL AUGMENTATION IMPLANT DEVICE (December 22, 2005)
  • K041018 — DRG SOFTRELEASE (October 18, 2004)
  • K012535 — DRG DISPOSABLE VAGINAL SPECULUM (March 1, 2002)
  • K012003 — DRG REACTION CHAMBER/SAFETY TIP (February 12, 2002)
  • K011736 — DRG QUICKMIX (January 30, 2002)
  • K013786 — DRG ORTHOHEX SS BONE SCREW (December 17, 2001)
  • K002047 — DRG PURETONE STETHOSCOPE WITH DRG ANTIMICROBIAL, STETHOSCOPE DIAPHRAGM, MODEL PT (November 22, 2000)
  • K991714 — DRG CONVENTIONAL ELECTRONIC DIGITAL STETHOSCOPE, MODEL ECHOP 200-00 (December 10, 1999)
  • K990920 — DRG TITANIUM BONE PLATE (June 10, 1999)
  • K981881 — DRG SHERLOCK MF BONE SCREW, COCRMO SELF-TAPPING, TI ALLOY SELF-TAPPING/SELF DRIL (December 2, 1998)

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)
  • K030605 — RAPID IMF (June 27, 2003)
  • 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