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510(k) K820944

DENTAL ARCH BAR by Unisplint Corp. — Product Code DYX

K820944 is an FDA 510(k) premarket notification submitted by Unisplint Corp. for the device "DENTAL ARCH BAR". The FDA issued a decision of Substantially Equivalent on May 5, 1982. The device falls under product code DYX (Lock, Wire, And Ligature, Intraoral), a Class II device regulated under 21 CFR 872.4600. Unisplint Corp. has at least 1 other 510(k) clearance on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 5, 1982
Date Received
April 6, 1982
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 Unisplint Corp.

  • K830675 — ORAL SPONGE (March 24, 1983)

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)
  • 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)

FDA data resources