| Primary Device ID | E22115271 |
| NIH Device Record Key | afd101e7-7f12-4db0-8d09-20f274fabdd2 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | AlignerFlow LC |
| Version Model Number | 1527 |
| Catalog Number | 1527 |
| Company DUNS | 316699578 |
| Company Name | VOCO GmbH |
| Device Count | 1 |
| 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 |
| 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 |
| Storage Environment Temperature | Between 4 Degrees Celsius and 28 Degrees Celsius |
| Storage Environment Temperature | Between 4 Degrees Celsius and 28 Degrees Celsius |
| Storage Environment Temperature | Between 4 Degrees Celsius and 28 Degrees Celsius |
| Storage Environment Temperature | Between 4 Degrees Celsius and 28 Degrees Celsius |
| Storage Environment Temperature | Between 4 Degrees Celsius and 28 Degrees Celsius |
| Storage Environment Temperature | Between 4 Degrees Celsius and 28 Degrees Celsius |
| Storage Environment Temperature | Between 4 Degrees Celsius and 28 Degrees Celsius |
| Storage Environment Temperature | Between 4 Degrees Celsius and 28 Degrees Celsius |
| Storage Environment Temperature | Between 4 Degrees Celsius and 28 Degrees Celsius |
| Storage Environment Temperature | Between 4 Degrees Celsius and 28 Degrees Celsius |
| Storage Environment Temperature | Between 4 Degrees Celsius and 28 Degrees Celsius |
| Storage Environment Temperature | Between 4 Degrees Celsius and 28 Degrees Celsius |
| Storage Environment Temperature | Between 4 Degrees Celsius and 28 Degrees Celsius |
| Storage Environment Temperature | Between 4 Degrees Celsius and 28 Degrees Celsius |
| Storage Environment Temperature | Between 4 Degrees Celsius and 28 Degrees Celsius |
| Storage Environment Temperature | Between 4 Degrees Celsius and 28 Degrees Celsius |
| Storage Environment Temperature | Between 4 Degrees Celsius and 28 Degrees Celsius |
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | E22115271 [Primary] |
| DYH | Adhesive, Bracket And Tooth Conditioner, Resin |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2023-12-14 |
| Device Publish Date | 2023-12-06 |
| E22115291 | AlignerFlow LC is a flowable, light-curing and fluorescent nanohybrid composite for aligner atta |
| E22115281 | AlignerFlow LC is a flowable, light-curing and fluorescent nanohybrid composite for aligner atta |
| E22115271 | AlignerFlow LC is a flowable, light-curing and fluorescent nanohybrid composite for aligner atta |
| E22115261 | AlignerFlow LC is a flowable, light-curing and fluorescent nanohybrid composite for aligner atta |