SureSmile®
GUDID 90856379007118
Indirect Bonding (IDB) Tray
ORAMETRIX, INC.
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| NIH Device Record Key | 52757392-1a96-4dcd-8281-06fe6ce1f627 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | SureSmile® |
| Version Model Number | DIGI-500128 |
| Company DUNS | 053101262 |
| Company Name | ORAMETRIX, INC. |
| Device Count | 1 |
| DM Exempt | false |
| 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 | false |
| Serial Number | true |
| 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 |
|---|---|
| GS1 | 90856379007118 [Primary] |
FDA Product Code
| EBH | Material, Impression Tray, Resin |
| QJJ | Indirect Bonding Tray |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | false |
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2021-11-09 |
| Device Publish Date | 2021-05-28 |
On-Brand Devices [SureSmile® ]
| 00856379007269 | Retainer |
| 90856379007118 | Indirect Bonding (IDB) Tray |
| 00856379007252 | Arch wire 18x18 CUNITI-NITI |
| 00856379007245 | Arch wire 19x25 BETA TITANIUM |
| 00856379007238 | Arch wire 17x25 BETA TITANIUM |
| 00856379007221 | Arch wire 16x22 BETA TITANIUM |
| 00856379007214 | Arch wire 16x16 BETA TITANIUM |
| 00856379007207 | Arch wire 16round BETA TITANIUM |
| 00856379007191 | Arch wire 16x16 NITI |
| 00856379007184 | Arch wire 16x22 AZURLOY-ELGILOY |
| 00856379007177 | Arch wire 19x25 ELGILOY |
| 00856379007160 | Arch wire 17x25 ELGILOY |
| 00856379007153 | Arch wire 19x25 CUNITI-NITI |
| 00856379007146 | Arch wire 17x25 CUNITI-NITI |
| 00856379007139 | Arch wire 16x22 CUNITI-NITI |
| 00856379007122 | Arch wire 16round CUNITI-NITI |
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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