| Primary Device ID | D8410491E1A |
| NIH Device Record Key | f33b8dd1-9bf1-4371-ae5d-282bed7fce5b |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | TAP ELITE AND DREAM |
| Version Model Number | 0491E&D |
| Company DUNS | 006335558 |
| Company Name | Dyna Flex of Missouri, L.P. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | true |
| Lot Batch | false |
| Serial Number | false |
| Manufacturing Date | false |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | D8410491E1A [Primary] |
| LRK | Device, Anti-Snoring |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2018-03-29 |
| Device Publish Date | 2017-02-10 |
| D8410056G19 - ADJUSTABLE HERBST | 2018-07-06 ORAL SLEEP APNEA APPLIANE |
| D84100911Z - EZ-Align | 2018-07-06 Clear Sequential Aligner System |
| D8410091L1D - EZ-Align | 2018-07-06 Sequential Aligner (Lower Tray) |
| D84101101R - Dorsal Appliance | 2018-07-06 Dorsal oral sleep apnea device (Anti Snoring) |
| D84101511W - LISA APPLIANCE | 2018-07-06 LISA ORAL SLEEP APNEA APPLIANCE |
| D8410091U1M - EZ-Align | 2018-03-29 Orthodontic Plastic Bracket (Sequential Aligners). Upper Tray |
| D84104841 - EMA APPLIANCE | 2018-03-29 EMA ORAL SLEEP APNEA APPLIANCE |
| D84104911 - TAP 1 & 3 | 2018-03-29 TAP ORAL SLEEP APNEA DEVICE |