| Primary Device ID | 00810021430171 |
| NIH Device Record Key | 26878cd8-2a18-4e6b-8cd0-11df26d4d3dc |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | DCI Edge |
| Version Model Number | LT4 |
| Company DUNS | 032221423 |
| Company Name | DCI International, LLC |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | true |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | false |
| Lot Batch | false |
| Serial Number | false |
| Manufacturing Date | true |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | false |
| OTC Over-The-Counter | false |
| Phone | 503-537-2445 |
| regulatory@dcionline.com | |
| Phone | 503-537-2445 |
| regulatory@dcionline.com | |
| Phone | 503-537-2445 |
| regulatory@dcionline.com | |
| Phone | 503-537-2445 |
| regulatory@dcionline.com | |
| Phone | 503-537-2445 |
| regulatory@dcionline.com | |
| Phone | 503-537-2445 |
| regulatory@dcionline.com | |
| Phone | 503-537-2445 |
| regulatory@dcionline.com | |
| Phone | 503-537-2445 |
| regulatory@dcionline.com | |
| Phone | 503-537-2445 |
| regulatory@dcionline.com | |
| Phone | 503-537-2445 |
| regulatory@dcionline.com | |
| Phone | 503-537-2445 |
| regulatory@dcionline.com | |
| Phone | 503-537-2445 |
| regulatory@dcionline.com | |
| Phone | 503-537-2445 |
| regulatory@dcionline.com | |
| Phone | 503-537-2445 |
| regulatory@dcionline.com | |
| Phone | 503-537-2445 |
| regulatory@dcionline.com | |
| Phone | 503-537-2445 |
| regulatory@dcionline.com | |
| Phone | 503-537-2445 |
| regulatory@dcionline.com | |
| Phone | 503-537-2445 |
| regulatory@dcionline.com |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00810021430171 [Primary] |
| EAZ | Light, Operating, Dental |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2023-06-26 |
| Device Publish Date | 2023-06-16 |
| 00810021432380 | DCI Edge Over the Patient Auto Dental Unit Series 5 |
| 00810021432175 | DCI Edge Over the Patient Auto Dental Unit Series 4 |
| 00810021430928 | DCI Edge Side Delivery Auto Dental Unit Series 5 |
| 00810021430898 | DCI Edge Side Delivery Auto Dental Unit Series 4 |
| 00810021430843 | DCI Edge Swing Mount with Auto Dental Unit Series 5 |
| 00810021430775 | DCI Edge Swing Mount with Auto Dental Unit Series 4 |
| 00810021430669 | 12 O'clock Cabinet Mount Delivery System |
| 00810021430522 | Orthodontic Chair |
| 00810021430508 | Series 4 Dental Chair w/50 Watt Transformer, 230V |
| 00810021430492 | Series 4 Dental Chair w/50 Watt Transformer |
| 00810021430485 | Series 5 Dental Chair w/200 Watt Transformer, 230V |
| 00810021430478 | Series 5 Dental Chair w/200 Watt Transformer |
| 00810021430447 | Cabinet Mount Series 5 Light |
| 00810021430416 | Wall Mount Series 5 Light |
| 00810021430362 | Track Mount Series 5 Light |
| 00810021430324 | System Mount Series 4 Light |
| 00810021430300 | Post Mount Series 5 Light |
| 00810021430249 | Ceiling Mount Series 5 Light |
| 00810021430218 | Ceiling Mount Series 4 Light |
| 00810021430195 | Post Mount Series 4 Light |
| 00810021430171 | Track Mount Series 4 Light |
| 00810021430157 | Wall Mount Series 4 Light |
| 00810021430140 | Cabinet Mount Series 4 Light |
| 00810021430133 | Post Mount Reliance Light |
| 00810021430010 | System Mount Series 5 Light |
| 00810021432526 | Edge Automatic Control Cart |
| 00810021435268 | Ortho Cabinet |
| 00810021435275 | 12 O'Clock Floor Mount Delivery Series 5 |
| 00810021439327 | Series 5 12 O'Clock Floor Mount, Work Surface Only |
| 00810021439297 | Rear Mount on Chair w/Cuspidor and Assistants Arm, Series 5 |
| 00810021439280 | Rear Mount on Chair w/Cuspidor, Series 5 |
| 00810021439273 | Rear Mount International, Prep for Canttani |
| 00810021439266 | Rear Mount International, Prep for Durr |
| 00810021439259 | Rear Mount Assistant's Package, 1 Syringe, 1 HVE & 1 SE |
| 00810021439242 | Rear Mount Assistant's Pkg. |
| 00810021439235 | Rear Mount on Chair, Series 5 |
| 00810021439228 | Rear Mount on Chair w/Cuspidor and Assistants Arm, Series 4 |
| 00810021439211 | Rear Mount on Chair w/Cuspidor, Series 4 |
| 00810021439204 | Rear Mount Assistant's Package, 3 HP |
| 00810021439198 | Rear Mount on Chair, Series 4 |
| 00810021438924 | Series 4 Automatic Control Cart for 3 HP w/Premium Vacuum |
| 00810021438917 | Series 4 Automatic Control Cart for 3HP, Self-Contained |
| 00810021438825 | Series 4 Manual Control Cart for 2 HP |
| 00810021438818 | Series 4 Manual Control Cart for 2 HP w/Standard Vacuum |
| 00810021438801 | Series 4 Manual Control Cart for 2 HP w/Premium Vacuum |
| 00810021438795 | Operatory Support Cart w/Assistant's Package H-Frame |
| 00810021438788 | Operatory Support Cart w/Assistant's Package U-Frame |
| 00810021438771 | DCI Edge Over the Patient Euro-Style Dental Unit w/Large PMU, Cuspidor and PMU Assistant, Gray |
| 00810021438764 | DCI Edge Over the Patient Auto Dental Unit w/Large PMU, Cuspidor and PMU Assistant, Gray |
| 00810021438757 | DCI Edge Over the Patient Auto Dental Unit w/Large PMU and PMU Assistant Mount, Gray |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() DCI EDGE 85808338 4548566 Live/Registered |
DCI INTERNATIONAL, LLC 2012-12-20 |