DENTAL ARCH BAR
FDA 510(k) clearance K820944 · decided 1982-05-05
Clearance details
- K-number
- K820944
- Device name
- DENTAL ARCH BAR
- Applicant
- Unisplint Corp.
- Decision
- Substantially Equivalent
- Date received
- 1982-04-06
- Decision date
- 1982-05-05
- Days to decision
- 29 days
- Clearance type
- Traditional
- Product code
- DYX
- Device class
- 2
- Regulation number
- 872.4600
- Medical specialty
- Dental
- Advisory committee
- Dental
- Location
- Walker, MI, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| 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 |
Recalls involving this device
No recalls on record reference this clearance.