| Primary Device ID | 10190707108288 | 
| NIH Device Record Key | 0fe44393-7ec9-45cb-88ed-f8deabb6d9e2 | 
| Commercial Distribution Status | In Commercial Distribution | 
| Brand Name | Bite-Builder™ | 
| Version Model Number | OT-2350 | 
| Company DUNS | 062165188 | 
| Company Name | ORTHO ORGANIZERS, INC. | 
| Device Count | 10 | 
| 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 | true | 
| 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 | 
| Device Issuing Agency | Device ID | 
|---|---|
| GS1 | 00190707108281 [Primary] | 
| GS1 | 10190707108288 [Unit of Use] | 
| DYW | BRACKET, PLASTIC, 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 | 2025-10-03 | 
| Device Publish Date | 2025-09-25 | 
| 10190707115101 - TruFit™ 2.0 | 2025-10-07 TruFit™ 2.0 ASM .018 ROTH UR6 CONV SBT -10T 10DOff 29.5 (3PK) | 
| 10190707115118 - TruFit™ 2.0 | 2025-10-07 TruFit™ 2.0 ASM .018 ROTH UR6 CONV SBT -10T 10DOff 30.0 (3PK) | 
| 10190707115125 - TruFit™ 2.0 | 2025-10-07 TruFit™ 2.0 ASM .018 ROTH UR6 CONV SBT -10T 10DOff 30.5 (3PK) | 
| 10190707115132 - TruFit™ 2.0 | 2025-10-07 TruFit™ 2.0 ASM .018 ROTH UR6 CONV SBT -10T 10DOff 31.0 (3PK) | 
| 10190707115149 - TruFit™ 2.0 | 2025-10-07 TruFit™ 2.0 ASM .018 ROTH UR6 CONV SBT -10T 10DOff 31.5 (3PK) | 
| 10190707115156 - TruFit™ 2.0 | 2025-10-07 TruFit™ 2.0 ASM .018 ROTH UR6 CONV SBT -10T 10DOff 32.0 (3PK) | 
| 10190707115163 - TruFit™ 2.0 | 2025-10-07 TruFit™ 2.0 ASM .018 ROTH UR6 CONV SBT -10T 10DOff 32.5 (3PK) | 
| 10190707115170 - TruFit™ 2.0 | 2025-10-07 TruFit™ 2.0 ASM .018 ROTH UR6 CONV SBT -10T 10DOff 33.0 (3PK) | 
| Mark Image Registration | Serial | Company Trademark Application Date | 
|---|---|
|  BITE-BUILDER  77677910  3773181 Live/Registered | Ortho Technology, Inc. 2009-02-25 |