DYX · Lock, Wire, And Ligature, Intraoral
Dental · 21 CFR 872.4600 · Class 2
Overview
| Product Code | DYX |
|---|---|
| Device Name | Lock, Wire, And Ligature, Intraoral |
| Regulation | 21 CFR 872.4600 |
| Device Class | Class 2 |
| Review Panel | Dental |
| Implant | Yes |
Identification
An intraoral ligature and wire lock is a metal device intended to constrict fractured bone segments in the oral cavity. The bone segments are stabilized by wrapping the ligature (wire) around the fractured bone segments and locking the ends together.
Classification Rationale
Class II.
Cleared Devices (11)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K162046 | MINNE TIES MMF Suture System | Summit Medical, Inc. | Apr 11, 2017 | SESE |
| K061271 | ERCH ARCH BAR, MODEL 38-690-00 | KLS-Martin L.P. | Jun 30, 2006 | SESE |
| K031207 | SAFETY RELEASE ARCH BAR KIT | Casey Surgical, LLC | Jul 15, 2003 | SESE |
| K030605 | RAPID IMF | Zygomatics , Ltd. | Jun 27, 2003 | SESE |
| K990212 | LOCKJAW 15 MINUTE INTERMAXILLARY FIXATION SYSTEM,MODEL LJ100-00 | Doctor'S Research Group, Inc. | Sep 14, 1999 | SESE |
| K991004 | SYNTHES QUICK LOCK IMF SYSTEM | Synthes (Usa) | Jun 23, 1999 | SESE |
| K925106 | IMPLANTABLE PULSE GENERATORS | Medtronic Vascular | Oct 6, 1993 | SESE |
| K925712 | RELIANCE SHORT STICK TIE | Reliance Orthodontic Products, Inc. | Jan 11, 1993 | SESE |
| K910090 | DIMAC WIRES | Instrumentations Unltd. | Jul 25, 1991 | SESE |
| K863799 | JAW FIXATION ASSEMBLY | Medical Products & Research, Inc. | Oct 14, 1986 | SESE |
| K820944 | DENTAL ARCH BAR | Unisplint Corp. | May 5, 1982 | SESE |
Top Applicants
- Zygomatics , Ltd. — 1 clearance
- Unisplint Corp. — 1 clearance
- Synthes (Usa) — 1 clearance
- Summit Medical, Inc. — 1 clearance
- Reliance Orthodontic Products, Inc. — 1 clearance
