| Primary Device ID | D746EPOO4Y1 |
| NIH Device Record Key | 79dc75db-610d-4e63-803b-7de71ca4cd2e |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Pontic |
| Version Model Number | EPOO4-Y |
| Catalog Number | EPOO4-Y |
| 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 | D746EPOO4Y0 [Unit of Use] |
| HIBCC | D746EPOO4Y1 [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 |