OMNIARCH® 77-612-03
GUDID D80777612031
OmniArch® VS 022/L1 UNIV 0T 0A
DENTSPLY SIRONA ORTHODONTICS INC.
Orthodontic bracket, metal| Primary Device ID | D80777612031 |
| NIH Device Record Key | 5045babc-ca80-4048-8b20-58e0465c1045 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | OMNIARCH® |
| Version Model Number | 77-612-03 |
| Catalog Number | 77-612-03 |
| Company DUNS | 116903307 |
| Company Name | DENTSPLY SIRONA ORTHODONTICS INC. |
| Device Count | 10 |
| DM Exempt | true |
| 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 | 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 | D80777612030 [Unit of Use] |
| HIBCC | D80777612031 [Primary] |
FDA Product Code
| EJF | BRACKET, METAL, ORTHODONTIC |
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 | 2020-02-10 |
| Device Publish Date | 2019-09-30 |
On-Brand Devices [OMNIARCH®]
| D807K77552921 | OMNIARCH® RNC 022 UL/5-5 CS-BC HK |
| D807K77055621 | OMNIARCH® EURO 022 UL/5-5 CS-BC HK |
| D807K77055611 | OMNIARCH® EURO 022 UL/5-5 CS HK |
| D807K77055301 | OMNIARCH® BI-DIMENSIONAL® UL/5-5 CS HK |
| D807K77055281 | OMNIARCH® CETLIN® 022 UL/5-5 CS HK |
| D807K77055231 | OMNIARCH® Base Rx 022 UL/5-5 CS HK |
| D807K77055221 | OMNIARCH® Base Rx 022 UL/5-5 CS-BC HK |
| D807K77055131 | OMNIARCH® Base Rx 018 UL/5-5 CS HK |
| D807K77055121 | OMNIARCH® Base Rx 018 UL/5-5 CS-BC HK |
| D80777652331 | OmniArch® VS 022/L5 -17T OB |
| D80777652071 | OmniArch® Base Rx 022/L5 22NT UNIV OB |
| D80777652031 | OmniArch® VS 022/L5 UNIV -17T 0A |
| D80777652001 | OmniArch® Base Rx 022/L5 22NT 0A UNIV |
| D80777651721 | OmniArch® M-P 018/L5 17NT 0A |
| D80777651331 | OmniArch® VS 018/L5 -17T OB |
| D80777651071 | OmniArch® Base Rx 018/L5 22NT UNIV OB |
| D80777651031 | OmniArch® VS 018/L5 UNIV -17T 0A |
| D80777651001 | OmniArch® Base Rx 018/L5 22NT 0A UNIV |
| D80777642341 | OmniArch® VS BI-DIMENSIONAL® 022/L4-5 0T0A OB |
| D80777642331 | OmniArch® VS 022/L4 -11T OB |
| D80777642071 | OmniArch® Base Rx 022/L4 17NT UNIV OB |
| D80777642041 | OmniArch® VS BI-DIMENSIONAL® 022/L4-5 0T 0A |
| D80777642031 | OmniArch® VS 022/L4 UNIV -11T 0A |
| D80777642001 | OmniArch® Base Rx 022/L4 17NT 0A UNIV |
| D80777641721 | OmniArch® M-P 018/L4 11NT 0A |
| D80777641701 | OmniArch® M-P 018/L4-5 0T 0A |
| D80777641341 | OmniArch® VS BI-DIMENSIONAL® 018/L4-5 0T0A OB |
| D80777641331 | OmniArch® VS 018/L4 -11T OB |
| D80777641071 | OmniArch® Base Rx 018/L4 17NT UNIV OB |
| D80777641041 | OmniArch® VS BI-DIMENSIONAL® 018/L4-5 0T 0A |
| D80777641031 | OmniArch® VS 018/L4 UNIV -11T 0A |
| D80777641001 | OmniArch® Base Rx 018/L4 17NT 0A UNIV |
| D80777612901 | OmniArch® RNC 022/L1-2 1T 0A |
| D80777612601 | OmniArch® EURO 022/L1&2 UNIV 6NT 0A |
| D80777612231 | OmniArch® VS 022/L1-2 -5T 0A |
| D80777612061 | OmniArch® XTQ 022/L1-2 6T 0OF |
| D80777612031 | OmniArch® VS 022/L1 UNIV 0T 0A |
| D80777612021 | OmniArch® EXT 022/L1 UNIV -5T 0A TW |
| D80777612001 | OmniArch® Base Rx 022/L1-2 1NT 0A UNIV |
| D80777611901 | OmniArch® RNC 018/L1-2 1T 0A |
| D80777611601 | OmniArch® EURO 018 LOWER 1&2 -6T 0A 0OF |
| D80777611401 | OmniArch® HAS 018/L1&2 UNIV 0T 0A |
| D80777611061 | OmniArch® XTQ 018/L1-2 6T 0OF |
| D80777611031 | OmniArch® VS 018/L1 UNIV 0T 0A |
| D80777611021 | OmniArch® EXT 018/L1 UNIV -5T 0A TW |
| D80777611001 | OmniArch® Base Rx 018/L1-2 1NT 0A UNIV |
| D80777552601 | OmniArch® EURO 022/U5 7NT |
| D80777552001 | OmniArch® Base Rx 022/U5 7NT 0A UNIV |
| D80777551601 | OmniArch® EURO 018 UPR R&L 5 -7T0A0OF |
| D80777551001 | OmniArch® Base Rx 018/U5 7NT 0A UNIV |
Trademark Results [OMNIARCH]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 OMNIARCH 86639771 5263240 Live/Registered |
OMNIARCH FINANCIAL INC. 2015-05-22 |
 OMNIARCH 86639760 5279081 Live/Registered |
OMNIARCH FINANCIAL INC. 2015-05-22 |
 OMNIARCH 75184516 2144215 Live/Registered |
DENTSPLY SIRONA INC. 1996-10-21 |
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