VisCalor 6108
GUDID E221610810
VisCalor is a light-curing, radiopaque, nano-hybrid restorative material. Set contains Futurabond U
VOCO GmbH
Dentine bonding agent/set Dentine bonding agent/set Dentine bonding agent/set Dentine bonding agent/set Dentine bonding agent/set Dentine bonding agent/set Dentine bonding agent/set Dentine bonding agent/set Dentine bonding agent/set Dentine bonding agent/set Dentine bonding agent/set Dentine bonding agent/set Dentine bonding agent/set Dentine bonding agent/set Dentine bonding agent/set Dentine bonding agent/set Dentine bonding agent/set Dentine bonding agent/set Dentine bonding agent/set Dentine bonding agent/set Dentine bonding agent/set Dentine bonding agent/set Dentine bonding agent/set Dentine bonding agent/set Dentine bonding agent/set Dentine bonding agent/set Dentine bonding agent/set Dentine bonding agent/set| Primary Device ID | E221610810 |
| NIH Device Record Key | b65d0f02-6a8e-4c83-8b3c-97190b1c360c |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | VisCalor |
| Version Model Number | 6108 |
| Catalog Number | 6108 |
| Company DUNS | 316699578 |
| Company Name | VOCO GmbH |
| Device Count | 80 |
| 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 | true |
| 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 | |
| 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 |
| 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 | E22161081 [Primary] |
| HIBCC | E221610810 [Unit of Use] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K130486
FDA Product Code
| EMA | Cement, Dental |
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 | 2021-01-18 |
| Device Publish Date | 2021-01-08 |
On-Brand Devices [VisCalor]
| E22161230 | VisCalor is a light-curing, radiopaque, nano-hybrid restorative material. |
| E22161220 | VisCalor is a light-curing, radiopaque, nano-hybrid restorative material. |
| E22161210 | VisCalor is a light-curing, radiopaque, nano-hybrid restorative material. |
| E22161200 | VisCalor is a light-curing, radiopaque, nano-hybrid restorative material. |
| E22161190 | VisCalor is a light-curing, radiopaque, nano-hybrid restorative material. |
| E22161180 | VisCalor is a light-curing, radiopaque, nano-hybrid restorative material. |
| E22161170 | VisCalor is a light-curing, radiopaque, nano-hybrid restorative material. |
| E22161160 | VisCalor is a light-curing, radiopaque, nano-hybrid restorative material. |
| E22161150 | VisCalor is a light-curing, radiopaque, nano-hybrid restorative material. |
| E22161140 | VisCalor is a light-curing, radiopaque, nano-hybrid restorative material. |
| E22161130 | VisCalor is a light-curing, radiopaque, nano-hybrid restorative material. |
| E22161101 | VisCalor is a light-curing, radiopaque, nano-hybrid restorative material. |
| E221610910 | VisCalor is a light-curing, radiopaque, nano-hybrid restorative material. |
| E221610810 | VisCalor is a light-curing, radiopaque, nano-hybrid restorative material. Set contains Futurabon |
| E221610710 | VisCalor is a light-curing, radiopaque, nano-hybrid restorative material. Set contains Caps Warm |
| E22161060 | VisCalor is a light-curing, radiopaque, nano-hybrid restorative material. Set contains VisCalor |
Trademark Results [VisCalor]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 VISCALOR 79255870 5929430 Live/Registered |
VOCO GmbH 2019-02-25 |
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.