Home / 510(k) Clearances / K061271

510(k) K061271

ERCH ARCH BAR, MODEL 38-690-00 by KLS-Martin L.P. — Product Code DYX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 30, 2006
Date Received
May 5, 2006
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 KLS-Martin L.P.

  • K253660 — KLS Martin Pure Pectus System (February 20, 2026)
  • K250988 — KLS Martin Pure Pectus System (December 11, 2025)
  • K250865 — KLS Martin IPS Forearm System (November 14, 2025)
  • K252573 — KLS Martin Cranial Implants - MR Conditional; K944565: KLS-Martin Micro Osteosyn (November 10, 2025)
  • K233721 — KLS Martin Drill-Free MMF Screw (September 17, 2024)
  • K241314 — KLS Martin Oral-Max Implants MR Conditional (bundled) (August 16, 2024)
  • K241018 — KLS Martin Orthopedic Implants - MR Conditional (July 12, 2024)
  • K230211 — CranioXpand (November 21, 2023)
  • K222624 — KLS Martin LINOS Wrist System (May 25, 2023)
  • K222397 — KLS Martin Level One Rib Fixation System (March 29, 2023)

Other clearances for product code DYX

  • K162046 — MINNE TIES MMF Suture System (April 11, 2017)
  • 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)
  • K820944 — DENTAL ARCH BAR (May 5, 1982)