| Primary Device ID | 00190746062896 |
| NIH Device Record Key | d2f5f287-d4b0-450d-bcfb-d305ccbd227b |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | BracePaste Fluoride Sealant Kit |
| Version Model Number | 020-039668 |
| Catalog Number | 020-039668 |
| 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 | 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 | +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 | |
| 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 |
| Storage Environment Temperature | Between 10 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Away from Light |
| Storage Environment Temperature | Between 10 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Away from Light |
| Storage Environment Temperature | Between 10 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Away from Light |
| Storage Environment Temperature | Between 10 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Away from Light |
| Storage Environment Temperature | Between 10 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Away from Light |
| Storage Environment Temperature | Between 10 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Away from Light |
| Storage Environment Temperature | Between 10 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Away from Light |
| Storage Environment Temperature | Between 10 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Away from Light |
| Storage Environment Temperature | Between 10 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Away from Light |
| Storage Environment Temperature | Between 10 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Away from Light |
| Storage Environment Temperature | Between 10 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Away from Light |
| Storage Environment Temperature | Between 10 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Away from Light |
| Storage Environment Temperature | Between 10 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Away from Light |
| Storage Environment Temperature | Between 10 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Away from Light |
| Storage Environment Temperature | Between 10 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Away from Light |
| Storage Environment Temperature | Between 10 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Away from Light |
| Storage Environment Temperature | Between 10 Degrees Celsius and 25 Degrees Celsius |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00190746062896 [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 | 2024-11-05 |
| Device Publish Date | 2024-10-28 |
| 00190746061356 - Cleo | 2025-01-22 COSMETIC CLEO UR BIC 018 T-7 A=0 R=0 |
| 00190746062964 - Mini Master Series | 2025-01-22 DB BKT MINI MS UR CEN 022 T+22 A+5 R=0 GP |
| 00190746062971 - Mini Master Series | 2025-01-22 DB BKT MINI MS UL CEN 022 T+22 A+5 R=0 GP |
| 00190746062988 - Mini Master Series | 2025-01-22 DB BKT MINI MS UR LAT 022 T+14 A+8 R=0 GP |
| 00190746063008 - Mini Master Series | 2025-01-22 DB BKT MINI MS UL LAT 022 T+14 A+8 R=0 GP |
| 00190746063015 - Mini Master Series | 2025-01-22 DB BKT MINI MS UR CUSP 022 T=0 A+7 R=0 GP |
| 00190746063022 - Mini Master Series | 2025-01-22 DB BKT MINI MS UL CUSP 022 T=0 A+7 R=0 GP |
| 00190746063046 - Mini Master Series | 2025-01-22 DB BKT MINI MS LR CUSP 022 T=0 A+5 R=0 BEV GP |