| Primary Device ID | 00190746150753 | 
| NIH Device Record Key | 6978ec47-ec2d-4b44-8c34-5d42ff504161 | 
| Commercial Distribution Status | In Commercial Distribution | 
| Brand Name | 300 Series Facebow | 
| Version Model Number | 852-375 | 
| Catalog Number | 852-375 | 
| 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 | |
| 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 | 
| Device Issuing Agency | Device ID | 
|---|---|
| GS1 | 00190746150753 [Primary] | 
| KCR | FACEBOW | 
| Steralize Prior To Use | false | 
| Device Is Sterile | false | 
| Public Version Status | New | 
| Device Record Status | Published | 
| Public Version Number | 1 | 
| Public Version Date | 2019-10-08 | 
| Device Publish Date | 2019-09-30 | 
| 00190746150760 | FACEBOW LOOP STYLE SHORT OUTER BOW 045 SIZE 6 118MM | 
| 00190746150753 | FACEBOW LOOP STYLE SHORT OUTER BOW 045 SIZE 5 111MM | 
| 00190746150746 | FACEBOW LOOP STYLE SHORT OUTER BOW 045 SIZE 4 104MM | 
| 00190746150739 | FACEBOW LOOP STYLE SHORT OUTER BOW 045 SIZE 3 97MM | 
| 00190746150722 | FACEBOW LOOP STYLE SHORT OUTER BOW 045 SIZE 2 90MM | 
| 00190746150715 | FACEBOW LOOP STYLE W/BAYONET 045 SIZE 5 111MM | 
| 00190746150708 | FACEBOW LOOP STYLE W/BAYONET 045 SIZE 4 104MM | 
| 00190746150692 | FACEBOW LOOP STYLE W/BAYONET 045 SIZE 3 97MM | 
| 00190746150685 | FACEBOW LOOP STYLE W/BAYONET 045 SIZE 2 90MM | 
| 00190746150678 | FACEBOW LOOP STYLE 051 SIZE 6 118MM | 
| 00190746150661 | FACEBOW LOOP STYLE 051 SIZE 5 111MM | 
| 00190746150654 | FACEBOW LOOP STYLE 051 SIZE 4 104MM | 
| 00190746150647 | FACEBOW LOOP STYLE 051 SIZE 3 97MM | 
| 00190746150630 | FACEBOW LOOP STYLE 051 SIZE 2 90MM | 
| 00190746150616 | FACEBOW SHORT OUTER BOW 045 | 
| 00190746150609 | FACEBOW STANDARD OUTER BOW 045 | 
| 00190746150593 | FACEBOW LOOP STYLE 045 SIZE 6 118MM | 
| 00190746150586 | FACEBOW LOOP STYLE 045 SIZE 5 111MM | 
| 00190746150579 | FACEBOW LOOP STYLE 045 SIZE 4 104MM | 
| 00190746150562 | FACEBOW LOOP STYLE 045 SIZE 39 7MM | 
| 00190746150555 | FACEBOW LOOP STYLE 045 SIZE 2 90MM | 
| 00190746150623 | FACEBOW LONG OUTER BOW 045 |