3D Predict
GUDID D9393DS080
Orthodontic plastic aligner
3D SMILE USA, INC
Orthodontic appliance system, progressive Orthodontic appliance system, progressive Orthodontic appliance system, progressive Orthodontic appliance system, progressive Orthodontic appliance system, progressive Orthodontic appliance system, progressive Orthodontic appliance system, progressive Orthodontic appliance system, progressive Orthodontic appliance system, progressive Orthodontic appliance system, progressive Orthodontic appliance system, progressive Orthodontic appliance system, progressive Orthodontic appliance system, progressive Orthodontic appliance system, progressive Orthodontic progressive aligner Orthodontic progressive aligner Orthodontic progressive aligner Orthodontic progressive aligner Orthodontic progressive aligner Orthodontic progressive aligner Orthodontic progressive aligner Orthodontic progressive aligner Orthodontic progressive aligner| Primary Device ID | D9393DS080 |
| NIH Device Record Key | 13203be8-eb3d-43e7-8c9d-1d2bdc2f4dda |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | 3D Predict |
| Version Model Number | 3DS08 |
| Company DUNS | 117258618 |
| Company Name | 3D SMILE USA, INC |
| 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 | 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 |
Customer Support Contacts
| Phone | +1 (920) 332 4344 |
| support@3Dpredict.com | |
| Phone | +1 (920) 332 4344 |
| support@3Dpredict.com | |
| Phone | +1 (920) 332 4344 |
| support@3Dpredict.com | |
| Phone | +1 (920) 332 4344 |
| support@3Dpredict.com | |
| Phone | +1 (920) 332 4344 |
| support@3Dpredict.com | |
| Phone | +1 (920) 332 4344 |
| support@3Dpredict.com | |
| Phone | +1 (920) 332 4344 |
| support@3Dpredict.com | |
| Phone | +1 (920) 332 4344 |
| support@3Dpredict.com | |
| Phone | +1 (920) 332 4344 |
| support@3Dpredict.com | |
| Phone | +1 (920) 332 4344 |
| support@3Dpredict.com | |
| Phone | +1 (920) 332 4344 |
| support@3Dpredict.com | |
| Phone | +1 (920) 332 4344 |
| support@3Dpredict.com | |
| Phone | +1 (920) 332 4344 |
| support@3Dpredict.com | |
| Phone | +1 (920) 332 4344 |
| support@3Dpredict.com | |
| Phone | +1 (920) 332 4344 |
| support@3Dpredict.com | |
| Phone | +1 (920) 332 4344 |
| support@3Dpredict.com | |
| Phone | +1 (920) 332 4344 |
| support@3Dpredict.com | |
| Phone | +1 (920) 332 4344 |
| support@3Dpredict.com | |
| Phone | +1 (920) 332 4344 |
| support@3Dpredict.com | |
| Phone | +1 (920) 332 4344 |
| support@3Dpredict.com | |
| Phone | +1 (920) 332 4344 |
| support@3Dpredict.com | |
| Phone | +1 (920) 332 4344 |
| support@3Dpredict.com | |
| Phone | +1 (920) 332 4344 |
| support@3Dpredict.com |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | D9393DS080 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K200214
FDA Product Code
| NXC | Aligner, Sequential |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | false |
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2020-08-14 |
| Device Publish Date | 2020-08-06 |
Trademark Results [3D Predict]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 3D PREDICT 90818228 not registered Live/Pending |
KIYATEC Inc. 2021-07-08 |
 3D PREDICT 88733773 not registered Live/Pending |
3D Smile USA Inc. 2019-12-19 |
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