| Primary Device ID | 00190746074776 | 
| NIH Device Record Key | 76727e82-4018-4137-89f8-000072d0a57e | 
| Commercial Distribution Status | In Commercial Distribution | 
| Brand Name | Bondable Retainer | 
| Version Model Number | 855-283 | 
| Catalog Number | 855-283 | 
| 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 | |
| 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 | |
| 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 | 
| Device Issuing Agency | Device ID | 
|---|---|
| GS1 | 00190746074776 [Primary] | 
| DYT | MAINTAINER, SPACE PREFORMED, ORTHODONTIC | 
| Steralize Prior To Use | false | 
| Device Is Sterile | false | 
| Public Version Status | New | 
| Device Record Status | Published | 
| Public Version Number | 1 | 
| Public Version Date | 2019-07-02 | 
| Device Publish Date | 2019-06-24 | 
| 00190746075063 | SPACE MAINTAINER 23MM RIGHT 5/PKG | 
| 00190746075056 | SPACE MAINTAINER 23MM LEFT 5/PKG | 
| 00190746075049 | SPACE MAINTAINER 21MM RIGHT 5/PKG | 
| 00190746075032 | SPACE MAINTAINER 21MM LEFT 5/PKG | 
| 00190746075025 | SPACE MAINTAINER 19MM RIGHT 5/PKG | 
| 00190746075018 | SPACE MAINTAINER 19MM LEFT 5/PKG | 
| 00190746075001 | SPACE MAINTAINER 17MM RIGHT 5/PKG | 
| 00190746074998 | SPACE MAINTAINER 17MM LEFT 5/PKG | 
| 00190746074974 | RETAINER MAX LATERAL TO LATERAL 20MM 5/PKG | 
| 00190746074967 | RETAINER MAX LATERAL TO LATERAL 18MM 5/PKG | 
| 00190746074950 | RETAINER MAX LATERAL TO LATERAL 16MM 5/PKG | 
| 00190746074943 | RETAINER MAX LATERAL TO LATERAL 14MM 5/PKG | 
| 00190746074929 | RETAINER BICUSPID TO BICUSPID 42MM | 
| 00190746074912 | RETAINER BICUSPID TO BICUSPID 40MM | 
| 00190746074905 | RETAINER BICUSPID TO BICUSPID 38MM | 
| 00190746074899 | RETAINER BICUSPID TO BICUSPID 36MM | 
| 00190746074868 | RETAINER MAX CENTRAL TO CENTRAL 7.5MM 5/PKG | 
| 00190746074851 | RETAINER MAX CENTRAL TO CENTRAL 9MM 5/PKG | 
| 00190746074844 | RETAINER MAX CENTRAL TO CENTRAL 6MM 5/PKG | 
| 00190746074837 | RETAINER MAX CENTRAL TO CENTRAL 4MM 5/PKG | 
| 00190746074820 | RETAINER MAND CUSPID TO CUSPID 22MM HARD 5/PKG | 
| 00190746074813 | RETAINER MAND CUSPID TO CUSPID 22MM 5/PKG | 
| 00190746074806 | RETAINER MAND CUSPID TO CUSPID 30MM HARD 5/PKG | 
| 00190746074790 | RETAINER MAND CUSPID TO CUSPID 30MM 5/PKG | 
| 00190746074783 | RETAINER MAND CUSPID TO CUSPID 28MM HARD 5/PKG | 
| 00190746074776 | RETAINER MAND CUSPID TO CUSPID 28MM 5/PKG | 
| 00190746074769 | RETAINER MAND CUSPID TO CUSPID 26MM HARD 5/PKG | 
| 00190746074752 | RETAINER MAND CUSPID TO CUSPID 26MM 5/PKG | 
| 00190746074745 | RETAINER MAND CUSPID TO CUSPID 24MM HARD 5/PKG | 
| 00190746074738 | RETAINER MAND CUSPID TO CUSPID 24MM 5/PKG | 
| 00190746152894 | RETAINER MAND CUSPID TO CUSPID 22MM 100/PK | 
| 00190746152887 | RETAINER MAND CUSPID TO CUSPID 30MM 100/PK | 
| 00190746152870 | RETAINER MAND CUSPID TO CUSPID 28MM 100/PK | 
| 00190746152863 | RETAINER MAND CUSPID TO CUSPID 26MM 100/PK | 
| 00190746152856 | RETAINER MAND CUSPID TO CUSPID 24MM 100/PK | 
| 00190746074936 | RETAINER MAX LATERAL TO LATERAL KIT OF 20 | 
| 00190746074882 | RETAINER BICUSPID TO BICUSPID KIT OF 20 | 
| 00190746074875 | RETAINER MAX CENTRAL TO CENTRAL KIT OF 20 | 
| 00190746074721 | RETAINER MAND CUSPID TO CUSPID KIT OF 20 - HARD | 
| 00190746074714 | RETAINER MAND CUSPID TO CUSPID KIT OF 20 |