Lock, Wire, And Ligature, Intraoral
The Intraoral Wire Lock and Ligature is a dental device used to secure arch wires to orthodontic brackets or to ligate teeth together for immobilization, and it is placed and retained within the oral cavity during treatment. It is classified as FDA Class 2, indicating moderate risk, and requires 510(k) clearance before marketing. The product code is DYX and the applicable regulation is 21 CFR 872.4600, under the Dental medical specialty. This device is an implant.
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Basic Information
- Product Code
- DYX
- Device Class
- FDA class 2
- Regulation Number
- 872.4600
- Medical Specialty
- Dental
- Review Panel
- DE
- Submission Type
- 1
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 11 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K162046 | MINNE TIES MMF Suture System | Apr 11, 2017 | Substantially Equivalent | Summit Medical, Inc. |
| K061271 | ERCH ARCH BAR, MODEL 38-690-00 | Jun 30, 2006 | Substantially Equivalent | KLS-Martin L.P. |
| K031207 | SAFETY RELEASE ARCH BAR KIT | Jul 15, 2003 | Substantially Equivalent | Casey Surgical, LLC |
| K030605 | RAPID IMF | Jun 27, 2003 | Substantially Equivalent | Zygomatics , Ltd. |
| K990212 | LOCKJAW 15 MINUTE INTERMAXILLARY FIXATION SYSTEM,MODEL LJ100-00 | Sep 14, 1999 | Substantially Equivalent | Doctor'S Research Group, Inc. |
| K991004 | SYNTHES QUICK LOCK IMF SYSTEM | Jun 23, 1999 | Substantially Equivalent | Synthes (Usa) |
| K925106 | IMPLANTABLE PULSE GENERATORS | Oct 06, 1993 | Substantially Equivalent | Medtronic Vascular |
| K925712 | RELIANCE SHORT STICK TIE | Jan 11, 1993 | Substantially Equivalent | Reliance Orthodontic Products, Inc. |
| K910090 | DIMAC WIRES | Jul 25, 1991 | Substantially Equivalent | Instrumentations Unltd. |
| K863799 | JAW FIXATION ASSEMBLY | Oct 14, 1986 | Substantially Equivalent | Medical Products & Research, Inc. |
| K820944 | DENTAL ARCH BAR | May 05, 1982 | Substantially Equivalent | Unisplint Corp. |
FEI Numbers
This FDA classification entry is associated with 6 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 6 registration numbers. Click on an entry to view related FDA registrations.