| Primary Device ID | 00190746056352 |
| NIH Device Record Key | 645a7630-5329-4061-9212-f889d284dcda |
| Commercial Distribution Discontinuation | 2018-12-17 |
| Commercial Distribution Status | Not in Commercial Distribution |
| Brand Name | Auxillary |
| Version Model Number | 851-639 |
| Catalog Number | 851-639 |
| Company DUNS | 044668515 |
| Company Name | AMERICAN ORTHODONTICS CORPORATION |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | true |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | true |
| Device Combination Product | false |
| Single Use | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | false |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Phone | 800-558-7687 |
| info@americnaortho.com |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00190746056352 [Primary] |
| ECO | Spring, Orthodontic |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 4 |
| Public Version Date | 2018-12-18 |
| Device Publish Date | 2017-10-25 |
| 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 |