Admira Fusion 2805
GUDID E22128050
Universal nanohybrid ORMOCER restorative material.
VOCO GmbH
Dental composite resin Dental composite resin Dental composite resin Dental composite resin Dental composite resin Dental composite resin Dental composite resin Dental composite resin Dental composite resin Dental composite resin Dental composite resin Dental composite resin Dental composite resin Dental composite resin Dental composite resin Dental composite resin Dental composite resin| Primary Device ID | E22128050 |
| NIH Device Record Key | 34744f4d-c8a2-442a-99f3-bddbfbc859d2 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Admira Fusion |
| Version Model Number | 2805 |
| Catalog Number | 2805 |
| Company DUNS | 316699578 |
| Company Name | VOCO GmbH |
| Device Count | 15 |
| 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 | false |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | false |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
Customer Support Contacts
| Phone | 999-999-9999 |
| xxx@xx.xx | |
| Phone | 999-999-9999 |
| xxx@xx.xx | |
| Phone | 999-999-9999 |
| xxx@xx.xx | |
| Phone | 999-999-9999 |
| xxx@xx.xx | |
| Phone | 999-999-9999 |
| xxx@xx.xx | |
| Phone | 999-999-9999 |
| xxx@xx.xx | |
| Phone | 999-999-9999 |
| xxx@xx.xx | |
| Phone | 999-999-9999 |
| xxx@xx.xx | |
| Phone | 999-999-9999 |
| xxx@xx.xx | |
| Phone | 999-999-9999 |
| xxx@xx.xx | |
| Phone | 999-999-9999 |
| xxx@xx.xx | |
| Phone | 999-999-9999 |
| xxx@xx.xx | |
| Phone | 999-999-9999 |
| xxx@xx.xx | |
| Phone | 999-999-9999 |
| xxx@xx.xx | |
| Phone | 999-999-9999 |
| xxx@xx.xx | |
| Phone | 999-999-9999 |
| xxx@xx.xx | |
| Phone | 999-999-9999 |
| xxx@xx.xx |
Operating and Storage Conditions
| Storage Environment Temperature | Between 4 Degrees Celsius and 23 Degrees Celsius |
| Storage Environment Temperature | Between 4 Degrees Celsius and 23 Degrees Celsius |
| Storage Environment Temperature | Between 4 Degrees Celsius and 23 Degrees Celsius |
| Storage Environment Temperature | Between 4 Degrees Celsius and 23 Degrees Celsius |
| Storage Environment Temperature | Between 4 Degrees Celsius and 23 Degrees Celsius |
| Storage Environment Temperature | Between 4 Degrees Celsius and 23 Degrees Celsius |
| Storage Environment Temperature | Between 4 Degrees Celsius and 23 Degrees Celsius |
| Storage Environment Temperature | Between 4 Degrees Celsius and 23 Degrees Celsius |
| Storage Environment Temperature | Between 4 Degrees Celsius and 23 Degrees Celsius |
| Storage Environment Temperature | Between 4 Degrees Celsius and 23 Degrees Celsius |
| Storage Environment Temperature | Between 4 Degrees Celsius and 23 Degrees Celsius |
| Storage Environment Temperature | Between 4 Degrees Celsius and 23 Degrees Celsius |
| Storage Environment Temperature | Between 4 Degrees Celsius and 23 Degrees Celsius |
| Storage Environment Temperature | Between 4 Degrees Celsius and 23 Degrees Celsius |
| Storage Environment Temperature | Between 4 Degrees Celsius and 23 Degrees Celsius |
| Storage Environment Temperature | Between 4 Degrees Celsius and 23 Degrees Celsius |
| Storage Environment Temperature | Between 4 Degrees Celsius and 23 Degrees Celsius |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | E22128050 [Unit of Use] |
| HIBCC | E22128051 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K150784
FDA Product Code
| EBF | Material, Tooth Shade, Resin |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | false |
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2023-11-14 |
| Device Publish Date | 2023-11-06 |
On-Brand Devices [Admira Fusion]
| E22128091 | Universal nanohybrid ORMOCER restorative material. |
| E22128061 | Universal nanohybrid ORMOCER restorative material. |
| E22128041 | Universal nanohybrid ORMOCER restorative material. |
| E22128031 | Universal nanohybrid ORMOCER restorative material. |
| E22128011 | Universal nanohybrid ORMOCER restorative material. |
| E22128001 | Universal nanohybrid ORMOCER restorative material. |
| E22127991 | Universal nanohybrid ORMOCER restorative material. |
| E22127981 | Universal nanohybrid ORMOCER restorative material. |
| E22127961 | Universal nanohybrid ORMOCER restorative material. |
| E22127941 | Universal nanohybrid ORMOCER restorative material. |
| E22127921 | Universal nanohybrid ORMOCER restorative material. |
| E22127911 | Universal nanohybrid ORMOCER restorative material. |
| E22127901 | Universal nanohybrid ORMOCER restorative material. |
| E22127881 | Universal nanohybrid ORMOCER restorative material. |
| E22127871 | Universal nanohybrid ORMOCER restorative material. |
| E22127861 | Universal nanohybrid ORMOCER restorative material. |
| E22127851 | Universal nanohybrid ORMOCER restorative material. |
| E22127841 | Universal nanohybrid ORMOCER restorative material. |
| E22127831 | Universal nanohybrid ORMOCER restorative material. |
| E22127821 | Universal nanohybrid ORMOCER restorative material. |
| E22127811 | Universal nanohybrid ORMOCER restorative material. |
| E22127801 | Universal nanohybrid ORMOCER restorative material. This kit contains different shades of Admira |
| E22127791 | Universal nanohybrid ORMOCER restorative material. |
| E22127781 | trial set |
| E22127761 | Universal nanohybrid ORMOCER restorative material. |
| E22127751 | Universal nanohybrid ORMOCER restorative material. |
| E22127731 | Universal nanohybrid ORMOCER restorative material. |
| E22127721 | Universal nanohybrid ORMOCER restorative material. |
| E22127711 | Universal nanohybrid ORMOCER restorative material. |
| E22127701 | Universal nanohybrid ORMOCER restorative material. |
| E22127681 | Universal nanohybrid ORMOCER restorative material. |
| E22127661 | Universal nanohybrid ORMOCER restorative material. |
| E22127641 | Universal nanohybrid ORMOCER restorative material. |
| E22127631 | Universal nanohybrid ORMOCER restorative material. |
| E22127621 | Universal nanohybrid ORMOCER restorative material. |
| E22127601 | Universal nanohybrid ORMOCER restorative material. |
| E22127591 | Universal nanohybrid ORMOCER restorative material. |
| E22127581 | Universal nanohybrid ORMOCER restorative material. |
| E22127571 | Universal nanohybrid ORMOCER restorative material. |
| E22127561 | Universal nanohybrid ORMOCER restorative material. |
| E22127551 | Universal nanohybrid ORMOCER restorative material. |
| E22127541 | Universal nanohybrid ORMOCER restorative material. |
| E22127521 | Shade guide. |
| E22127511 | Universal nanohybrid ORMOCER restorative material. |
| E22127501 | Universal nanohybrid ORMOCER restorative material. This kit contains different shades of Admira |
| E22128050 | Universal nanohybrid ORMOCER restorative material. |
| E22127771 | Universal nanohybrid ORMOCER restorative material. |
Trademark Results [Admira Fusion]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 ADMIRA FUSION 79248428 not registered Live/Pending |
VOCO GmbH 2018-11-09 |
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