510(k) K162046
- Device
- MINNE TIES MMF Suture System
- Applicant
- SUMMIT MEDICAL, INC.
- 510(k) number
- K162046
- Product code
- DYX
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2017-04-11
- Date received
- 2016-07-25
- Regulation
- 872.4600
- Classification name
- Lock, Wire, And Ligature, Intraoral
- Medical specialty
- Dental
- Review panel
- Dental
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- Nicole Dove
- Address
- 815 Northwest Pkwy., Suite 100 St. Paul MN US 55121 55121
FDA Registration Numbers#
- 3003418325
- 3023158661
- 3008812560
- 3004215117
- 2183744
- 2080222
Source Documents#
Other 510(k) Records For Product Code DYX #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K061271 | ERCH ARCH BAR, MODEL 38-690-00 | KLS-Martin L.P. | 2006-06-30 |
| K031207 | SAFETY RELEASE ARCH BAR KIT | Casey Surgical, LLC | 2003-07-15 |
| K030605 | RAPID IMF | Zygomatics , Ltd. | 2003-06-27 |
| K990212 | LOCKJAW 15 MINUTE INTERMAXILLARY FIXATION SYSTEM,MODEL LJ100-00 | Doctor'S Research Group, Inc. | 1999-09-14 |
| K991004 | SYNTHES QUICK LOCK IMF SYSTEM | Synthes (Usa) | 1999-06-23 |
| K925106 | IMPLANTABLE PULSE GENERATORS | Medtronic Vascular | 1993-10-06 |
| K925712 | RELIANCE SHORT STICK TIE | Reliance Orthodontic Products, Inc. | 1993-01-11 |
| K910090 | DIMAC WIRES | Instrumentations Unltd. | 1991-07-25 |
| K863799 | JAW FIXATION ASSEMBLY | Medical Products & Research, Inc. | 1986-10-14 |
| K820944 | DENTAL ARCH BAR | Unisplint Corp. | 1982-05-05 |
Legacy Summary#
summary
FDA Review#
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