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 |