| Primary Device ID | 00190746075889 |
| NIH Device Record Key | 0a734b6c-dcec-483b-b61f-3329635dbe32 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | YC3 Shield |
| Version Model Number | 855-711M |
| Catalog Number | 855-711M |
| 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 | false |
| 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 | +1(800)558-7687 |
| info@americanortho.com | |
| Phone | +1(800)558-7687 |
| info@americanortho.com | |
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| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00190746075889 [Primary] |
| BRW | Protector, dental |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2020-09-14 |
| Device Publish Date | 2020-09-04 |
| 00190746151514 | YC3 CLASS III MIXED DENTITION APPLIANCE MIXED DENTITION 116/PK |
| 00190746151507 | YC3 CLASS III CORRECTION APPLIANCE PRIMARY DENTITION 140/PK |
| 00190746075889 | YC3 CLASS III MIXED DENTITION APPLIANCE MIXED DENTITION |
| 00190746075872 | YC3 CLASS III CORRECTION APPLIANCE PRIMARY DENTITION |