| Primary Device ID | 00810126506313 |
| NIH Device Record Key | 3801341b-2d31-43c2-856e-64f7b621c0d6 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Dream by 3D Dental |
| Version Model Number | USTP-T8 |
| Company DUNS | 080194935 |
| Company Name | 3D DENTAL DESIGNS AND DEVELOPMENT, LLC |
| Device Count | 1 |
| 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 | false |
| 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 |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00810126506313 [Primary] |
| ELC | Scaler, Ultrasonic |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2026-03-13 |
| Device Publish Date | 2026-03-05 |
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| 00817169029274 | Bi-Level Premium Toothbrush 72/Box |
| 00817169029267 | Adult Denture Brushes 12/Bag |
| 00817169029250 | Adult Premier Cleaner Toothbrush 72/Box |
| 00817169029243 | Adult Disposable Toothbrush Prepasted 144/Box |
| 00817169029236 | Childrens Toothbrush Sparkly 144/Box |
| 00817169024187 | Dream - Disposable Prophy Angle - Firm - 500pk |
| 00817169024170 | Dream - Disposable Prophy Angle - Soft - 144pk |
| 00817169024163 | Dream - Disposable Prophy Angle - Firm - 144pk |
| 00817169024156 | Dream - Disposable Prophy Angle - Soft - 100pk |
| 00817169024149 | Dream - Disposable Prophy Angle - Firm - 100pk |
| 00810126504371 | Adult Toothbrush Twist Compact 72/Box |
| 00817169029892 | Children's Toothbrush Extra soft 72/Box |
| 00810126506320 | T9 Scaler Tip For EMS Style unit |
| 00810126506313 | T8 Scaler Tip For EMS Style unit |
| 00810126506306 | T7 Scaler Tip For EMS Style unit |
| 00810126506290 | T6 Scaler Tip For EMS Style unit |
| 00810126506283 | T5 Scaler Tip For EMS Style unit |
| 00810126506276 | T4 Scaler Tip For EMS Style unit |
| 00810126506269 | T3 Scaler Tip For EMS Style unit |
| 00810126506252 | T2 Scaler Tip For EMS Style unit |
| 00810126506245 | T1 Scaler Tip For EMS Style unit |
| 00810126506238 | E1 Scaler Tip For EMS Style unit |