Surgical devices · 21 CFR 872 Subpart E
Intraoral Wire Lock and Ligature
FDA device type “Lock, Wire, And Ligature, Intraoral”.
- Companies listing it
- 62 makers
- Brands and models
- 11
- 510(k) clearances
- 110 in five years
- FDA name
- Lock, Wire, And Ligature, Intraoral
510(k) clearances per year, 1976–2026
Companies that list DYX
6 companies currently list this device type with FDA.
| Company | Country | Role | Brands and models listed | Clearances | Latest |
|---|---|---|---|---|---|
| SYNTHES (USA) Products LLC | United States | Maker | AND LIGATURE · INTRAORAL · LOCK · SYNTHES QUICK LOCK IMF SYSTEM | 7 | 2020 |
| Invisian Medical LLC | United States | Maker | Minne Ties Agile MMF | — | — |
| Integra LifeSciences Corporation | United States | Contract manufacturer | Integra · Jarit · Miltex · Padgett · +1 | 2 | 2014 |
| STERIS Corporation | United States | Contract sterilizer | — | — | — |
| E A Beck & Company | United States | Repacker / relabeler | LOCK, WIRE, AND LIGATURE, INTRAORAL | — | — |
| Avalign Technologies | United States | Contract manufacturer | — | — | — |
510(k) clearances
| Decided | 510(k) | Device | Applicant |
|---|---|---|---|
| 11 Apr 2017 | K162046 | MINNE TIES MMF Suture System | Summit Medical, LLC |
| 30 Jun 2006 | K061271 | ERCH ARCH BAR, MODEL 38-690-00 | KLS Martin SE & Co. KG |
| 15 Jul 2003 | K031207 | SAFETY RELEASE ARCH BAR KIT | Casey Surgical, LLC |
| 27 Jun 2003 | K030605 | RAPID IMF | Zygomatics , Ltd. |
| 14 Sep 1999 | K990212 | LOCKJAW 15 MINUTE INTERMAXILLARY FIXATION SYSTEM,MODEL LJ100-00 | Doctor'S Research Group, Inc. |
| 23 Jun 1999 | K991004 | SYNTHES QUICK LOCK IMF SYSTEM | Synthes (Usa) |
| 6 Oct 1993 | K925106 | IMPLANTABLE PULSE GENERATORS | Medtronic Vascular |
| 11 Jan 1993 | K925712 | RELIANCE SHORT STICK TIE | Reliance Orthodontic Products, Inc. |
| 25 Jul 1991 | K910090 | DIMAC WIRES | Instrumentations Unltd. |
| 14 Oct 1986 | K863799 | JAW FIXATION ASSEMBLY | Medical Products & Research, Inc. |
| 5 May 1982 | K820944 | DENTAL ARCH BAR | Unisplint Corp. |
Official records: FDA product classification for DYX · 21 CFR 872.4600.
Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026