SureSmile® ORX00001
GUDID D746ORX000010
SureSmile Dr Starter Kit
DENTSPLY SIRONA ORTHODONTICS INC.
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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