| Primary Device ID | D746EPOO4W1 | 
| NIH Device Record Key | e24305e0-9486-445b-a9aa-3a659061ea3f | 
| Commercial Distribution Status | In Commercial Distribution | 
| Brand Name | Pontic | 
| Version Model Number | EPOO4-W | 
| Catalog Number | EPOO4-W | 
| Company DUNS | 116903307 | 
| Company Name | DENTSPLY SIRONA ORTHODONTICS INC. | 
| Device Count | 6 | 
| DM Exempt | true | 
| 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 | true | 
| Lot Batch | true | 
| Serial Number | false | 
| Manufacturing Date | true | 
| Expiration Date | false | 
| Donation Id Number | false | 
| Contains Natural Rubber Latex | false | 
| Labeled No Natural Rubber Latex | true | 
| RX Perscription | true | 
| OTC Over-The-Counter | false | 
| Phone | +1(844)848-0137 | 
| essix.sales@dentsplysirona.com | |
| Phone | +1(844)848-0137 | 
| essix.sales@dentsplysirona.com | |
| Phone | +1(844)848-0137 | 
| essix.sales@dentsplysirona.com | |
| Phone | +1(844)848-0137 | 
| essix.sales@dentsplysirona.com | |
| Phone | +1(844)848-0137 | 
| essix.sales@dentsplysirona.com | |
| Phone | +1(844)848-0137 | 
| essix.sales@dentsplysirona.com | |
| Phone | +1(844)848-0137 | 
| essix.sales@dentsplysirona.com | |
| Phone | +1(844)848-0137 | 
| essix.sales@dentsplysirona.com | |
| Phone | +1(844)848-0137 | 
| essix.sales@dentsplysirona.com | |
| Phone | +1(844)848-0137 | 
| essix.sales@dentsplysirona.com | |
| Phone | +1(844)848-0137 | 
| essix.sales@dentsplysirona.com | |
| Phone | +1(844)848-0137 | 
| essix.sales@dentsplysirona.com | |
| Phone | +1(844)848-0137 | 
| essix.sales@dentsplysirona.com | |
| Phone | +1(844)848-0137 | 
| essix.sales@dentsplysirona.com | |
| Phone | +1(844)848-0137 | 
| essix.sales@dentsplysirona.com | |
| Phone | +1(844)848-0137 | 
| essix.sales@dentsplysirona.com | |
| Phone | +1(844)848-0137 | 
| essix.sales@dentsplysirona.com | 
| Device Issuing Agency | Device ID | 
|---|---|
| HIBCC | D746EPOO4W0 [Unit of Use] | 
| HIBCC | D746EPOO4W1 [Primary] | 
| ELM | Denture, plastic, teeth | 
| Steralize Prior To Use | false | 
| Device Is Sterile | false | 
| Public Version Status | Update | 
| Device Record Status | Published | 
| Public Version Number | 3 | 
| Public Version Date | 2023-10-30 | 
| Device Publish Date | 2016-09-24 | 
| D746EPOO4Y1 | 6pc Pontic Set - Yellow | 
| D746EPOO4W1 | 6pc Pontic Set - White |