| Primary Device ID | 00190730004505 |
| NIH Device Record Key | 1fce4cc6-0e2b-42a0-8685-352203b3ba55 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Metal Primer |
| Version Model Number | OT-ME |
| Company DUNS | 781772017 |
| Company Name | ORTHO TECHNOLOGY, INC. |
| Device Count | 1 |
| DM Exempt | true |
| 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 | false |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | true |
| Expiration Date | true |
| 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 | 00190730004505 [Primary] |
| DYH | ADHESIVE, BRACKET AND TOOTH CONDITIONER, RESIN |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2018-07-06 |
| Device Publish Date | 2016-09-24 |
| 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 |