| Primary Device ID | 00190746007835 |
| NIH Device Record Key | 8d4571c4-84e4-4640-86fe-9e9c62da33af |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Procelain Conditioner |
| Version Model Number | 001-966 |
| Catalog Number | 001-966 |
| 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 |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Away from Light |
| 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 |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00190746007835 [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 |
| 00190746067549 - PowerScope | 2026-04-01 FIXED FUNCT POWERSCOPE RIGHT MECHANISM |
| 00190746067563 - PowerScope | 2026-04-01 FIXED FUNCT POWERSCOPE LEFT MECHANISM |
| 00190746067587 - PowerScope | 2026-04-01 FIXED FUNCT POWERSCOPE ALT ATTACHMENT NUTS 5 RIGHT AND 5 LEFT |
| 00190746153273 - PowerScope | 2026-04-01 FIXED FUNCT POWERSCOPE ATTACHMENT NUTS 5 RIGHT AND 5 LEFT |
| 00190746202742 - PowerScope | 2026-04-01 FIXED FUNCT POWERSCOPE 5/KIT |
| 00190746202759 - PowerScope | 2026-04-01 FIXED FUNCT POWERSCOPE 1/KIT |
| 00190746191602 - Empower Bracket | 2026-03-31 DB BKT SL EMPOWER V-SLOT INTERACT UR CEN 018 T+12 A+5 R=0 |
| 00190746191619 - Empower Bracket | 2026-03-31 DB BKT SL EMPOWER V-SLOT INTERACT UR LAT 018 T+8 A+9 R=0 |