| Primary Device ID | 00190730087904 |
| NIH Device Record Key | d2579b62-1f4c-4d23-8d67-7cace2a3bab2 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Ortho Performance® Relief Wax |
| Version Model Number | 600-008 |
| Company DUNS | 781772017 |
| Company Name | ORTHO TECHNOLOGY, INC. |
| Device Count | 1 |
| DM Exempt | true |
| 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 | 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 | 00190730087904 [Primary] |
| EGD | WAX, DENTAL, INTRAORAL |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2021-09-24 |
| Device Publish Date | 2021-09-16 |
| 00190730087966 | Orthosil™ Relief Silicone Assorted Sparkle - 50 per pack |
| 00190730087959 | Ortho Performance® Relief Wax Cotton Candy - 50 per pack |
| 00190730087942 | Ortho Performance® Relief Wax Chocolate - 50 per pack |
| 00190730087935 | Ortho Performance® Relief Wax Coconut - 50 per pack |
| 00190730087928 | Ortho Performance® Relief Wax Silver - 50 per pack |
| 00190730087911 | Ortho Performance® Relief Wax Blueberry - 50 per pack |
| 00190730087904 | Ortho Performance® Relief Wax Pineapple - 50 per pack |
| 00190730087898 | Ortho Performance® Relief Wax Bubblegum - 50 per pack |
| 00190730087881 | Ortho Performance® Relief Wax Glow - 50 per pack |
| 00190730087874 | Ortho Performance® Relief Wax Mint - 50 per pack |
| 00190730087867 | Ortho Performance® Relief Wax Cinnamon - 50 per pack |
| 00190730087850 | Ortho Performance® Relief Wax Cherry - 50 per pack |
| 00190730087843 | Ortho Performance® Relief Wax Orange - 50 per pack |
| 00190730087836 | Ortho Performance® Relief Wax Grape - 50 per pack |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() ORTHO PERFORMANCE 77341281 3613317 Live/Registered |
Ortho Technology, Inc. 2007-11-30 |