DYX
11 FDA 510(k) clearances · Product code
90 daysmedian time to decision
260 days90th percentile
11clearances measured
FDA profile
- Official device name
- Lock, Wire, And Ligature, Intraoral
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 872.4600
- Medical specialty
- Dental
- Flags
- Implant
- Adverse events (MAUDE)
- 2005: 2
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| MINNE TIES MMF Suture System (K162046) | Summit Medical, Inc. | 2017-04-11 |
| ERCH ARCH BAR, MODEL 38-690-00 (K061271) | KLS-Martin L.P. | 2006-06-30 |
| SAFETY RELEASE ARCH BAR KIT (K031207) | Casey Surgical, LLC | 2003-07-15 |
| RAPID IMF (K030605) | Zygomatics , Ltd. | 2003-06-27 |
| LOCKJAW 15 MINUTE INTERMAXILLARY FIXATION SYSTEM,MODEL LJ100-00 (K990212) | Doctor'S Research Group, Inc. | 1999-09-14 |
| SYNTHES QUICK LOCK IMF SYSTEM (K991004) | Synthes (Usa) | 1999-06-23 |
| IMPLANTABLE PULSE GENERATORS (K925106) | Medtronic Vascular | 1993-10-06 |
| RELIANCE SHORT STICK TIE (K925712) | Reliance Orthodontic Products, Inc. | 1993-01-11 |
| DIMAC WIRES (K910090) | Instrumentations Unltd. | 1991-07-25 |
| JAW FIXATION ASSEMBLY (K863799) | Medical Products & Research, Inc. | 1986-10-14 |
| DENTAL ARCH BAR (K820944) | Unisplint Corp. | 1982-05-05 |
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Every clearance here is in the API, with alerts when new ones post.