dentsplysirona.com
essix.comPontic - 6pc Pontic Set - White
2016-09-24
Dentsply Sirona Orthodontics Inc.
FDA Registration(s)#
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 1036212 | 1036212 | Dentsply Sirona Orthodontics Inc. | 1 | Y | 2026-01-01 | 7290 26th Court East Sarasota FL US 34243 |
| 1649995 | 3001947560 | Dentsply Sirona Orthodontics Inc. | 1 | N | 2026-01-01 | 1125 E Campbell Rd Ste 100 RICHARDSON TX US 75081 |
| 2086211 | 3001586030 | Dentsply Sirona Orthodontics Inc. | 1 | Y | 2020-04-25 | 280 AVENIDA CAMPILLO STE J CALEXICO CA US 92231 |
GUDID Contact Samples#
| Source GUDID | Product | Phone | |
|---|---|---|---|
| D746ELA6G1 | Lower Anterior Pontic - Lower Anterior Pontic - Gray Set of 6 | +1(800)883-8733 | sales@essix.com |
| D746ELA6G1 | Lower Anterior Pontic - Lower Anterior Pontic - Gray Set of 6 | +1(844)848-0137 | essix.sales@dentsplysirona.com |
Registered Device Listings#
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 141239 | 1167972067 | K922499 | REFLECTIONS - CERAMIC DENTAL BRACKET | EJF | 1992-07-30 |
| 236733 | 1938443510 | K260722 | SureSmile Aligner (ASSY500020) | NXC | 2026-04-15 |
| 236733 | 1684198045 | K253565 | SureSmile Software | PNN | 2026-03-04 |
| 236733 | 1595159397 | K171860 | Sureclear aligners | NXC | 2018-01-05 |
| 141239 | 1333934395 | K163155 | MTM Clear Aligner | NXC | 2017-02-03 |
| 141239 | 1153880356 | K132145 | MTM(R) CLEAR ALIGNER | NXC | 2013-10-11 |
| 141239 | 1462096846 | K123925 | MTM CLEAR ALIGNER IN-OFFICE | NXC | 2013-05-24 |
| 141239 | 1873968171 | K092030 | ELATION MB METAL REINFORCED PLASTIC BRACKET | DYW | 2009-07-24 |
| 141239 | 1072067026 | K090454 | ALLURE MB CERAMIC BRACKETS | NJM | 2009-03-20 |
| 141239 | 1657933684 | K082974 | MYSTIQUE MB CERAMIC BRACKETS | NJM | 2008-11-07 |
| 141239 | 1676516868 | K080246 | COMPOSITE ALIGNER BUTTON | NXC | 2008-04-11 |
| 141239 | 1584116870 | K072522 | THERMOFORM SHEET MATERIALS AND ACCESSORIES | MQC | 2007-11-16 |
| 141239 | 1816627095 | K062828 | MOUTHGUARD AND ALIGNER MATERIALS | MQC | 2006-11-27 |
| 141239 | 1965015062 | K060836 | VISTADENT OC - VERSION 4 | LLZ | 2006-10-27 |
| 141239 | 1044110349 | K053368 | INTERPROXIMAL REDUCTION SYSTEM | EFB | 2006-03-29 |
| 236733 | 1117724265 | K002620 | SURESMILE SYSTEM | EIA | 2000-11-16 |
| 141239 | 1038047394 | ||||
| 141239 | 1138789642 | ||||
| 141239 | 1140794781 | ||||
| 141239 | 1147812230 | ||||
| 141239 | 1214451657 | ||||
| 141239 | 1235463921 | ||||
| 141239 | 1259858292 | ||||
| 141239 | 1265198837 | ||||
| 141239 | 1285172911 | ||||
| 141239 | 1340007421 | ||||
| 141239 | 1347116199 | ||||
| 141239 | 1406337521 | ||||
| 141239 | 1438566132 | ||||
| 141239 | 1445235455 | ||||
| 141239 | 1551896334 | ||||
| 141239 | 1624532138 | ||||
| 141239 | 1646775811 | ||||
| 141239 | 1646795082 | ||||
| 141239 | 1652769001 | ||||
| 141239 | 1666254191 | ||||
| 141239 | 1678722230 | ||||
| 141239 | 1691666886 | ||||
| 141239 | 1776896318 | ||||
| 141239 | 1840003839 | ||||
| 141239 | 1936570130 | ||||
| 141239 | 1959683304 | ||||
| 141239 | 1969505735 | ||||
| 141239 | 2008077674 | ||||
| 236733 | 2018329748 | ||||
| 141239 | 2064426041 | ||||
| 236733 | 1035737669 | ||||
| 141239 | 1035737669 | ||||
| 141239 | 1041372107 | ||||
| 141239 | 1075190190 | ||||
| 236733 | 1111104015 | ||||
| 141239 | 1324931125 | ||||
| 141239 | 1326033461 | ||||
| 141239 | 1349050331 | ||||
| 141239 | 1386001033 | ||||
| 141239 | 1389362822 | ||||
| 141239 | 1413517943 | ||||
| 141239 | 1489927009 | ||||
| 236733 | 1678722230 | ||||
| 141239 | 1731352728 | ||||
| 141239 | 1833371632 | ||||
| 141239 | 1869599463 | ||||
| 236733 | 1936570130 | ||||
| 141239 | 2046677122 |
Product Codes Associated With Registrations#
GUDID#
Pontic - 6pc Pontic Set - Yellow
2016-09-24
RETAINER BRITE® - Retainer Brite® Patient PAK 100PK
2021-05-01
Lower Anterior Pontic - Lower Anterior Pontic - Gray Set of 6
2016-09-24
Lower Anterior Pontic - Lower Anterior Pontic - White Set of 6
2016-09-24
Lower Anterior Pontic - Lower Anterior Pontic - Yellow Set of 6
2016-09-24
Essix® - Upper Lateral - Tapered Pontic - White Set of 6
2016-09-24
Essix® - Upper Lateral - Tapered Pontic - Yellow Set of 6
2016-09-24
Posterior Lower Pontic - Posterior Lower Pontic Set - Gray
2016-09-24
Posterior Lower Pontic - Posterior Lower Pontic Set - White
2016-09-24
Posterior Lower Pontic - Posterior Lower Pontic Set - Yellow
2016-09-24
Posterior Lower Pontic - Posterior Upper Pontic Set - Gray Set of 8
2016-09-24
Posterior Lower Pontic - Posterior Upper Pontic Set - White Set of 8
2016-09-24
Posterior Lower Pontic - Posterior Upper Pontic Set - Yellow Set of 8
2016-09-24
Square Upper Pontic - Square Upper Pontic - White Set of 6
2016-09-24
Square Upper Pontic - Square Upper Pontic - Yellow Set of 6
2016-09-24
Essix - Tapered Upper Anterior Pontic - Gray Set of 6
2016-09-24
Essix - Tapered Upper Anterior Pontic - White Set of 6
2016-09-24
Essix - Tapered Upper Anterior Pontic - Yellow Set of 6
2016-09-24
SpaceFile® - SpaceFile®IPR Strips-Dbl Sided-Medium/Blue
2021-12-16
N/A - Finishing Diamond - Ext. Head 5PK
2021-12-22
Retainer Retriever - RETAINER RETRIEVER - WHITE 10PK
2021-12-23
Picasso - Picasso Plus Package with multi-tip handpiece
2016-09-24
Essix A+ - "Essix A+ plastic .120mm x 5"" Square 25/PK"
2016-09-24
Essix - Essix 3mm Niteguard Laminate Clear Square PK/12
2016-09-24
DURAGUARD - DURAGUARD CLEAR .040(1mm) ROUND EACH
2016-09-24
IN-OVATION® C - IN-OVATION® C CCO 022/UR3 LT 0T 10A 2M HK
2017-06-26
IN-OVATION® C - IN-OVATION® C EURO 022/UR3 -7T 8A HK
2017-06-26
IN-OVATION® C - IN-OVATION® C Base Rx 022/UR4&5-7T0A2DHK
2017-06-26
IN-OVATION® C - IN-OVATION® C TGO 020X028/UL2 8T 9A
2017-06-26
IN-OVATION® C - IN-OVATION® C Roncone 018/LR3 -3T7A 2M
2017-06-26
IN-OVATION® C - IN-OVATION® C Roncone 022/L1&2 1T 0A
2017-06-26
ALLURE® MB - ALLURE® MB Base Rx .022 UR4 -7T 0A 2D HK
2017-06-26
MYSTIQUE® MB - MYSTIQUE® MB Roncone 022/UL1 18T 5A
2017-06-26
MYSTIQUE® MB - MYSTIQUE® MB Roncone 022/LR3 -3T 7A 2M HK
2017-06-26
Resolve® Ceramic - Resolve® Ceramic M018 U5 -7T0A0O HU
2017-06-26
Ovation® C - Ovation® C Base Rx 022/UL2 8T 9A
2017-06-26
Ovation® C - Ovation® C Base Rx 022/UL3 -2T 13A 4M
2017-06-26
IN-OVATION® C - IN-OVATION® C Base Rx 018/LR3 -11T 7A 2M
2017-06-26
IN-OVATION® C - IN-OVATION® C Base Rx 022/LR3 -11T 7A 2M HK
2017-06-26