SureSmile® ORX00001
GUDID D746ORX000010
SureSmile Dr Starter Kit
DENTSPLY SIRONA ORTHODONTICS INC.
Dental abrasive strip, reusable Dental abrasive strip, reusable Dental abrasive strip, reusable Dental abrasive strip, reusable Dental abrasive strip, reusable Dental abrasive strip, reusable Dental abrasive strip, reusable Dental abrasive strip, reusable Dental abrasive strip, reusable Dental abrasive strip, reusable Dental abrasive strip, reusable Dental abrasive strip, reusable Dental abrasive strip, reusable Dental abrasive strip, reusable Dental abrasive strip, reusable Dental abrasive strip, reusable Dental abrasive strip, reusable Dental abrasive strip, reusable Dental abrasive strip, reusable Dental abrasive strip, reusable Dental abrasive strip, reusable Dental abrasive strip, reusable Dental abrasive strip, reusable Dental abrasive strip, reusable Dental abrasive strip, reusable Dental abrasive strip, reusable Dental abrasive strip, reusable Dental abrasive strip, reusable Dental abrasive strip, reusable| Primary Device ID | D746ORX000010 |
| NIH Device Record Key | 42889caf-f90d-4699-8105-db26b8e59edc |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | SureSmile® |
| Version Model Number | ORX00001 |
| Catalog Number | ORX00001 |
| Company DUNS | 116903307 |
| Company Name | DENTSPLY SIRONA ORTHODONTICS INC. |
| Device Count | 3 |
| DM Exempt | true |
| Pre-market Exempt | false |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | true |
| 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 |
Customer Support Contacts
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | D746ORX000010 [Unit of Use] |
| HIBCC | D746ORX000011 [Primary] |
FDA Product Code
| EGS | Handpiece, contra- and right-angle attachment, dental |
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 | 2021-05-10 |
| Device Publish Date | 2021-05-01 |
On-Brand Devices [SureSmile®]
| D746ORX000060 | SureSmile Dr Starter Kit, EU |
| D746ORX000010 | SureSmile Dr Starter Kit |
| D746ORX000051 | SureSmile® Aligner Patient Kit (Global) |
Trademark Results [SureSmile]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 SURESMILE 97058764 not registered Live/Pending |
Dentsply Sirona Orthodontics Inc. 2021-10-04 |
 SURESMILE 75818755 2724644 Live/Registered |
ORAMETRIX, INC. 1999-10-08 |
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