Primary Device ID | 00856379007207 |
NIH Device Record Key | 01e30176-9443-4edf-9aff-6536533f1060 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | SureSmile® |
Version Model Number | ASSY-000469 |
Catalog Number | ASSY-000469 |
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 |
Device Issuing Agency | Device ID |
---|---|
GS1 | 00856379007207 [Primary] |
DZC | Wire, Orthodontic |
Steralize Prior To Use | false |
Device Is Sterile | false |
Public Version Status | Update |
Device Record Status | Published |
Public Version Number | 2 |
Public Version Date | 2022-05-17 |
Device Publish Date | 2021-05-28 |
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 |
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 |