| Primary Device ID | D746531030 |
| NIH Device Record Key | 8e112d7a-0ee3-473b-ace2-3ed9739ac894 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | N/A |
| Version Model Number | 53103 |
| Catalog Number | 53103 |
| Company DUNS | 116903307 |
| Company Name | DENTSPLY SIRONA ORTHODONTICS INC. |
| Device Count | 10 |
| 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 | 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 |
| Phone | +1(844)848-0137 |
| essix.sales@dentsplysirona.com | |
| Phone | +1(844)848-0137 |
| essix.sales@dentsplysirona.com | |
| Phone | +1(844)848-0137 |
| essix.sales@dentsplysirona.com | |
| Phone | +1(844)848-0137 |
| essix.sales@dentsplysirona.com | |
| Phone | +1(844)848-0137 |
| essix.sales@dentsplysirona.com | |
| Phone | +1(844)848-0137 |
| essix.sales@dentsplysirona.com | |
| Phone | +1(844)848-0137 |
| essix.sales@dentsplysirona.com | |
| Phone | +1(844)848-0137 |
| essix.sales@dentsplysirona.com | |
| Phone | +1(844)848-0137 |
| essix.sales@dentsplysirona.com | |
| Phone | +1(844)848-0137 |
| essix.sales@dentsplysirona.com | |
| Phone | +1(844)848-0137 |
| essix.sales@dentsplysirona.com | |
| Phone | +1(844)848-0137 |
| essix.sales@dentsplysirona.com | |
| Phone | +1(844)848-0137 |
| essix.sales@dentsplysirona.com | |
| Phone | +1(844)848-0137 |
| essix.sales@dentsplysirona.com | |
| Phone | +1(844)848-0137 |
| essix.sales@dentsplysirona.com | |
| Phone | +1(844)848-0137 |
| essix.sales@dentsplysirona.com | |
| Phone | +1(844)848-0137 |
| essix.sales@dentsplysirona.com |
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | D746531030 [Unit of Use] |
| HIBCC | D746531031 [Primary] |
| EHM | Strip, Polishing Agent |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[D746531030]
Moist Heat or Steam Sterilization
[D746531030]
Moist Heat or Steam Sterilization
[D746531030]
Moist Heat or Steam Sterilization
[D746531030]
Moist Heat or Steam Sterilization
[D746531030]
Moist Heat or Steam Sterilization
[D746531030]
Moist Heat or Steam Sterilization
[D746531030]
Moist Heat or Steam Sterilization
[D746531030]
Moist Heat or Steam Sterilization
[D746531030]
Moist Heat or Steam Sterilization
[D746531030]
Moist Heat or Steam Sterilization
[D746531030]
Moist Heat or Steam Sterilization
[D746531030]
Moist Heat or Steam Sterilization
[D746531030]
Moist Heat or Steam Sterilization
[D746531030]
Moist Heat or Steam Sterilization
[D746531030]
Moist Heat or Steam Sterilization
[D746531030]
Moist Heat or Steam Sterilization
[D746531030]
Moist Heat or Steam Sterilization
[D746531030]
Moist Heat or Steam Sterilization
[D746531030]
Moist Heat or Steam Sterilization
[D746531030]
Moist Heat or Steam Sterilization
[D746531030]
Moist Heat or Steam Sterilization
[D746531030]
Moist Heat or Steam Sterilization
[D746531030]
Moist Heat or Steam Sterilization
[D746531030]
Moist Heat or Steam Sterilization
[D746531030]
Moist Heat or Steam Sterilization
[D746531030]
Moist Heat or Steam Sterilization
[D746531030]
Moist Heat or Steam Sterilization
[D746531030]
Moist Heat or Steam Sterilization
[D746531030]
Moist Heat or Steam Sterilization
[D746531030]
Moist Heat or Steam Sterilization
[D746531030]
Moist Heat or Steam Sterilization
[D746531030]
Moist Heat or Steam Sterilization
[D746531030]
Moist Heat or Steam Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2021-12-30 |
| Device Publish Date | 2021-12-22 |
| D807K190055001 | MTM® NO TRACE (TM) 018 UL/4-4 |
| D807K189551921 | In-Ovation R RNC/BASE/EURO 018 UL5-5 CS-BC HK |
| D807K100551921 | In-Ovation C/R RNC/BASE/EURO 018 UL5-5 CS-BC HK |
| D80738331071 | TEW T 018/U&L3 WD 7T STD |
| D80738322141 | TEW T 022/U2 MED 14T STD |
| D80738321141 | TEW T 018/U2 MED 14T STD |
| D80738311221 | TEW T 018/U1 WD 22T |
| D80738282251 | TEW 022/L6 WD -25T STD |
| D80738282101 | TEW 022/L6 WD -10T STD |
| D80738221141 | TEW 018/U2 MED 14T STD |
| D80738211471 | TEW 018/U1 XWD 22T |
| D80738211221 | TEW 018/U1 WD 22T STD |
| D80738211151 | TEW 018/U1 WD 15T STD |
| D80737691121 | LWS T 018/L1-2 NAR |
| D80737442221 | TEW D 022/U&L4-5 MED |
| D80737392221 | TEW T 022/L1-2 MED |
| D80737391221 | TEW T 018/L1-2 MED |
| D80737391121 | TEW T 018/L1-2 NAR |
| D80737382421 | TEW T 022/U&L6 XWD |
| D80737382321 | TEW T 022/U&L6 WD |
| D80737381321 | TEW T 018/U&L6 WD |
| D80737362101 | TEW T 022/L1-2 NAR LP TAP |
| D80737361201 | TEW T 018/L1-2 MED LP TAP |
| D80737361101 | TEW T 018/L1-2 NAR LP TAP |
| D80737352211 | TEW T 022/U4-5 MED OW TAP |
| D80737352201 | TEW T 022/L4-5 MED LP TAP |
| D80737351211 | TEW T 018/U4-5 MED OW TAP |
| D80737342321 | TEW T 022/U&L4-5 WD |
| D80737342221 | TEW T 022/U&L4-5 MED |
| D80737341221 | TEW T 018/U&L4-5 MED |
| D80737337321 | TEW T 022/UL3 WD PST |
| D80737336321 | TEW T 022/UR3 WD PST |
| D80737332321 | TEW T 022/U&L3 WD |
| D80737332221 | TEW T 022/U&L3 MED |
| D80737332201 | TEW T 022/L3 MED LP |
| D80737331321 | TEW T 018/U&L3 WD |
| D80737331221 | TEW T 018/U&L3 MED |
| D80737322221 | TEW T 022/U2 MED |
| D80737321221 | TEW T 018/U2 MED |
| D80737312421 | TEW T 022/U1 XWD |
| D80737312321 | TEW T 022/U1 WD |
| D80737311421 | TEW T 018/U1 XWD |
| D80737311321 | TEW T 018/U1 WD |
| D80737292221 | TEW 022/L1-2 MED |
| D80737292121 | TEW 022/L1-2 NAR |
| D80737291221 | TEW 018/L1-2 MED |
| D80737291121 | TEW 018/L1-2 NAR |
| D80737282421 | TEW 022/U&L6 XWD |
| D80737282321 | TEW 022/U&L6 WD |
| D80737281421 | TEW 018/U&L6 XWD |