| Primary Device ID | 00190746007699 |
| NIH Device Record Key | 87d7d4e6-7791-4222-97ac-cc80cc5e2ce8 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Eagle Fluorsure |
| Version Model Number | 001-915 |
| Catalog Number | 001-915 |
| Company DUNS | 044668515 |
| Company Name | AMERICAN ORTHODONTICS CORPORATION |
| 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 | 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 |
| Phone | +1(800)558-7687 |
| info@americanortho.com | |
| Phone | +1(800)558-7687 |
| info@americanortho.com | |
| Phone | +1(800)558-7687 |
| info@americanortho.com | |
| Phone | +1(800)558-7687 |
| info@americanortho.com | |
| Phone | +1(800)558-7687 |
| info@americanortho.com | |
| Phone | +1(800)558-7687 |
| info@americanortho.com | |
| Phone | +1(800)558-7687 |
| info@americanortho.com | |
| Phone | +1(800)558-7687 |
| info@americanortho.com | |
| Phone | +1(800)558-7687 |
| info@americanortho.com | |
| Phone | +1(800)558-7687 |
| info@americanortho.com | |
| Phone | +1(800)558-7687 |
| info@americanortho.com | |
| Phone | +1(800)558-7687 |
| info@americanortho.com | |
| Phone | +1(800)558-7687 |
| info@americanortho.com | |
| Phone | +1(800)558-7687 |
| info@americanortho.com | |
| Phone | +1(800)558-7687 |
| info@americanortho.com |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Away from Light |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Away from Light |
| Storage Environment Temperature | Between 20 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Away from Light |
| Storage Environment Temperature | Between 20 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Away from Light |
| Storage Environment Temperature | Between 20 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Away from Light |
| Storage Environment Temperature | Between 20 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Away from Light |
| Storage Environment Temperature | Between 20 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Away from Light |
| Storage Environment Temperature | Between 20 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Away from Light |
| Storage Environment Temperature | Between 20 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Away from Light |
| Storage Environment Temperature | Between 20 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Away from Light |
| Storage Environment Temperature | Between 20 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Away from Light |
| Storage Environment Temperature | Between 20 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Away from Light |
| Storage Environment Temperature | Between 20 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Away from Light |
| Storage Environment Temperature | Between 20 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Away from Light |
| Storage Environment Temperature | Between 20 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Away from Light |
| Storage Environment Temperature | Between 20 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Away from Light |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00190746007699 [Primary] |
| DYH | ADHESIVE, BRACKET AND TOOTH CONDITIONER, RESIN |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2018-07-06 |
| Device Publish Date | 2016-11-09 |
| 00190746070662 - NT3 | 2025-08-26 WIRE NITI FORM I LOWER 014X025 100/PK |
| 00190746070686 - NT3 | 2025-08-26 WIRE NITI FORM I UPPER 014X025 100/PK |
| 00190746070709 - NT3 | 2025-08-26 WIRE NITI FORM III LOWER 014X025 100/PK |
| 00190746070723 - NT3 | 2025-08-26 WIRE NITI FORM III UPPER 014X025 100/PK |
| 00190746064968 - NiTi Spring | 2025-08-21 NITI SPRING CLOSED COIL CONTINUOUS FORCE LIGHT 100g 9MM WITH EYELET 10/PK |
| 00190746064975 - NiTi Spring | 2025-08-21 NITI SPRING CLOSED COIL CONTINUOUS FORCE LIGHT 100g 12MM WITH EYELET 10/PK |
| 00190746064982 - NiTi Spring | 2025-08-21 NITI SPRING CLOSED COIL CONTINUOUS FORCE MED 150g 9MM WITH EYELET 10/PK |
| 00190746064999 - NiTi Spring | 2025-08-21 NITI SPRING CLOSED COIL CONTINUOUS FORCE MED 150g 12MM WITH EYELET 10/PK |