| Primary Device ID | 00190730011619 |
| NIH Device Record Key | d5f83b90-8352-4ab4-b3fe-c55ded12537c |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | High Heat Bite Stick |
| Version Model Number | OT-600-199 |
| Company DUNS | 781772017 |
| Company Name | ORTHO TECHNOLOGY, INC. |
| 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 | false |
| 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 | 00190730011619 [Primary] |
| ECS | PUSHER, BAND, 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 | 2019-05-10 |
| Device Publish Date | 2019-05-02 |
| 10190730084535 - Clear Advantage | 2025-08-01 Splint Material .020“ 50 sheets per pack |
| 10190730084542 - Clear Advantage | 2025-08-01 Splint Material .030“ – FOIL packaging of 50 |
| 10190730084559 - Clear Advantage | 2025-08-01 Splint Material .040“ 50 sheets per pack |
| 10190730084566 - Clear Advantage | 2025-08-01 Splint Material .060“ – FOIL packaging of 25 |
| 10190730084573 - Clear Advantage | 2025-08-01 Splint Material .080“ 25 sheets per pack |
| 10190730084580 - Sports Advantage | 2025-08-01 Mouthguard Plastic Clear .080“ 25 sheets per pack |
| 10190730084597 - Sports Advantage | 2025-08-01 Mouthguard Plastic Clear .040“ 25 sheets per pack |
| 00190730084682 - Ortho Technology | 2024-09-26 Boone Gauge Stainless Steel |