EsFlow PLUS
Spident Co., Ltd.
SPIDENT CO., LTD.
FDA Registration(s)#
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 3006113314 | 3006113314 | SPIDENT CO., LTD. | 1 | N | 2026-01-01 | 312, 151B-6L NAMDONGGONGDAN INCHEON Gyeonggi KR 405-821 |
Registered Device Listings#
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 25225 | 1438532638 | K992337 | BLOSSOM POWDER FREE LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM 50 MCGM OR LESS OF TOTAL WATER EXTRACTA | FMC | 1999-08-17 |
| 25225 | 1893574777 | K261129 | OrthoFit | DYH | 2026-07-02 |
| 25225 | 1618166904 | K250566 | EsCem RMGI | EMA | 2025-06-20 |
| 25225 | 2072275483 | K250317 | EsFlow PLUS | EBF | 2025-05-30 |
| 25225 | 1509006972 | K242702 | VioSeal | KIF | 2024-11-07 |
| 25225 | 1782119742 | K242675 | FineEtch (FineEtch-10 1.2ml, FineEtch-10 5ml, FineEtch-37 1.2ml FineEtch-37 5ml, FineEtch 37% 1.2ml 20ea pack) | KLE | 2024-11-01 |
| 25225 | 1755963881 | K241445 | K-Bond Universal | KLE | 2024-07-22 |
| 25225 | 1599128436 | K231523 | EsCom250 | EBF | 2023-07-24 |
| 25225 | 2043252342 | K214076 | EsCem | EMA | 2022-12-19 |
| 25225 | 1641330325 | K214071 | Hexa-Temp | EBG | 2022-03-10 |
| 25225 | 2008820754 | K161774 | i-Sil | ELW | 2016-09-30 |
| 25225 | 2073660802 | K134022 | BASE IT | EJK | 2014-06-11 |
| 25225 | 1122420231 | K134021 | ESTEMP IMPLANT, ESTEMP CLEAR | EMA | 2014-06-10 |
| 25225 | 1779524071 | K120768 | ES FLOW | EBF | 2012-05-03 |
| 25225 | 1983473065 | K120767 | ES BOND | KLE | 2012-05-24 |
| 25225 | 1400243877 | K110428 | ESCOM 100 | EBF | 2011-02-25 |
| 25225 | 1880686524 | K100413 | TEMP IT | EBF | 2010-03-03 |
| 25225 | 1608093184 | K100290 | ESTEMP NE | EMA | 2010-02-17 |
| 25225 | 1042916115 | K093751 | CL-DC20, CL-DC21 | EBZ | 2010-02-24 |
| 25225 | 1432374370 | K092572 | CORE*IT DUAL | EBF | 2009-08-26 |
| 25225 | 1744580636 | K023755 | WINNER EAR LOOP PROCEDURE MASK, TIE-ON SURGICAL MASK & EAR LOOP PROCEDURE MASK WITH SHIELD | FXX | 2003-06-10 |
| 25225 | 1537046983 | ||||
| 25225 | 1585233427 | ||||
| 25225 | 1645003790 | ||||
| 25225 | 1655409405 | ||||
| 25225 | 1737913018 | ||||
| 25225 | 1751105504 | ||||
| 25225 | 1751919299 | ||||
| 25225 | 1867502027 | ||||
| 25225 | 2041719580 |
Product Codes Associated With Registrations#
PMN#
VioSeal
Spident Co., Ltd.
FineEtch (FineEtch-10 1.2ml, FineEtch-10 5ml, FineEtch-37 1.2ml FineEtch-37 5ml, FineEtch 37% 1.2ml 20ea pack)
Spident Co., Ltd.
K-Bond Universal
Spident Co., Ltd.
EsCom250
Spident Co., Ltd.
EsCem
Spident Co., Ltd.
Hexa-Temp
SPIDENT CO., LTD.
I-Sil
SPIDENT Co., Ltd.
BASE IT
SPIDENT CO., LTD.
ESTEMP IMPLANT, ESTEMP CLEAR
SPIDENT CO., LTD.
ES BOND
SPIDENT CO., LTD.
ES FLOW
SPIDENT CO., LTD.
ESCOM 100
SPIDENT CO., LTD.
TEMP IT
SPIDENT CO., LTD.
ESTEMP NE
SPIDENT CO., LTD.
CORE*IT DUAL
SPIDENT CO., LTD.
GUDID#
EsCem - EsCem is a dual-cured resin cement that can be self-etched and self-adhesive. It is classified as type 2 and class 3 according to ISO 4049. It is easy to handle with 'one step' system that does not need pre-treatment process. It is easy to remove excess cement, so it is possible to perform quick operation. It is also easy to identify because it has a radio-opacity(1.2 mm Al). And it offers various shades for aesthetics and color stable.
2026-04-29
EsCem - EsCem is a dual-cured resin cement that can be self-etched and self-adhesive. It is classified as type 2 and class 3 according to ISO 4049. It is easy to handle with 'one step' system that does not need pre-treatment process. It is easy to remove excess cement, so it is possible to perform quick operation. It is also easy to identify because it has a radio-opacity(1.2 mm Al). And it offers various shades for aesthetics and color stable.
2026-04-29
EsCem - EsCem is a dual-cured resin cement that can be self-etched and self-adhesive. It is classified as type 2 and class 3 according to ISO 4049. It is easy to handle with 'one step' system that does not need pre-treatment process. It is easy to remove excess cement, so it is possible to perform quick operation. It is also easy to identify because it has a radio-opacity(1.2 mm Al). And it offers various shades for aesthetics and color stable.
2026-04-29
Temro.Flow - Temp it Flow are Light-Curing Flowable Temporary Filling Material. It has characteristics of high elasticity and high compressive strength. This elastic consistency assures easy removal from cavity, even in case of undercuts, final treatment of cavity is not necessary.
2026-04-28
Temro.Flow - Temp it Flow are Light-Curing Flowable Temporary Filling Material. It has characteristics of high elasticity and high compressive strength. This elastic consistency assures easy removal from cavity, even in case of undercuts, final treatment of cavity is not necessary.
2026-04-28
EsCom250 - EsCom250 is the polymer-based dental restorative material. It can be light-cured intra orally for anterior and posterior restoration including occlusal surface. Various shades of A1, A2, A3, A3.5, A4, B1, B2, C2, D2, G1, AO2, AO3 and TW for esthetic restoration are provided. All shades of EsCom250 are radio-opaque.
2026-04-21
EsCom250 - EsCom250 is the polymer-based dental restorative material. It can be light-cured intra orally for anterior and posterior restoration including occlusal surface. Various shades of A1, A2, A3, A3.5, A4, B1, B2, C2, D2, G1, AO2, AO3 and TW for esthetic restoration are provided. All shades of EsCom250 are radio-opaque.
2026-04-21
EsCom250 - EsCom250 is the polymer-based dental restorative material. It can be light-cured intra orally for anterior and posterior restoration including occlusal surface. Various shades of A1, A2, A3, A3.5, A4, B1, B2, C2, D2, G1, AO2, AO3 and TW for esthetic restoration are provided. All shades of EsCom250 are radio-opaque.
2026-04-21
EsCom250 - EsCom250 is the polymer-based dental restorative material. It can be light-cured intra orally for anterior and posterior restoration including occlusal surface. Various shades of A1, A2, A3, A3.5, A4, B1, B2, C2, D2, G1, AO2, AO3 and TW for esthetic restoration are provided. All shades of EsCom250 are radio-opaque.
2026-04-21
EsCom250 - EsCom250 is the polymer-based dental restorative material. It can be light-cured intra orally for anterior and posterior restoration including occlusal surface. Various shades of A1, A2, A3, A3.5, A4, B1, B2, C2, D2, G1, AO2, AO3 and TW for esthetic restoration are provided. All shades of EsCom250 are radio-opaque.
2026-04-21
EsCom250 - EsCom250 is the polymer-based dental restorative material. It can be light-cured intra orally for anterior and posterior restoration including occlusal surface. Various shades of A1, A2, A3, A3.5, A4, B1, B2, C2, D2, G1, AO2, AO3 and TW for esthetic restoration are provided. All shades of EsCom250 are radio-opaque.
2026-04-21
EsCom250 - EsCom250 is the polymer-based dental restorative material. It can be light-cured intra orally for anterior and posterior restoration including occlusal surface. Various shades of A1, A2, A3, A3.5, A4, B1, B2, C2, D2, G1, AO2, AO3 and TW for esthetic restoration are provided. All shades of EsCom250 are radio-opaque.
2026-04-21
EsCom250 - EsCom250 is the polymer-based dental restorative material. It can be light-cured intra orally for anterior and posterior restoration including occlusal surface. Various shades of A1, A2, A3, A3.5, A4, B1, B2, C2, D2, G1, AO2, AO3 and TW for esthetic restoration are provided. All shades of EsCom250 are radio-opaque.
2026-04-21
EsCom250 - EsCom250 is the polymer-based dental restorative material. It can be light-cured intra orally for anterior and posterior restoration including occlusal surface. Various shades of A1, A2, A3, A3.5, A4, B1, B2, C2, D2, G1, AO2, AO3 and TW for esthetic restoration are provided. All shades of EsCom250 are radio-opaque.
2026-04-21
EsCom250 - EsCom250 is the polymer-based dental restorative material. It can be light-cured intra orally for anterior and posterior restoration including occlusal surface. Various shades of A1, A2, A3, A3.5, A4, B1, B2, C2, D2, G1, AO2, AO3 and TW for esthetic restoration are provided. All shades of EsCom250 are radio-opaque.
2026-04-21
EsCom250 - EsCom250 is the polymer-based dental restorative material. It can be light-cured intra orally for anterior and posterior restoration including occlusal surface. Various shades of A1, A2, A3, A3.5, A4, B1, B2, C2, D2, G1, AO2, AO3 and TW for esthetic restoration are provided. All shades of EsCom250 are radio-opaque.
2026-04-21
EsCom250 - EsCom250 is the polymer-based dental restorative material. It can be light-cured intra orally for anterior and posterior restoration including occlusal surface. Various shades of A1, A2, A3, A3.5, A4, B1, B2, C2, D2, G1, AO2, AO3 and TW for esthetic restoration are provided. All shades of EsCom250 are radio-opaque.
2026-04-21
EsCom250 - EsCom250 is the polymer-based dental restorative material. It can be light-cured intra orally for anterior and posterior restoration including occlusal surface. Various shades of A1, A2, A3, A3.5, A4, B1, B2, C2, D2, G1, AO2, AO3 and TW for esthetic restoration are provided. All shades of EsCom250 are radio-opaque.
2026-04-21
EsCom250 - EsCom250 is the polymer-based dental restorative material. It can be light-cured intra orally for anterior and posterior restoration including occlusal surface. Various shades of A1, A2, A3, A3.5, A4, B1, B2, C2, D2, G1, AO2, AO3 and TW for esthetic restoration are provided. All shades of EsCom250 are radio-opaque.
2026-04-21
EsCom250 - EsCom250 is the polymer-based dental restorative material. It can be light-cured intra orally for anterior and posterior restoration including occlusal surface. Various shades of A1, A2, A3, A3.5, A4, B1, B2, C2, D2, G1, AO2, AO3 and TW for esthetic restoration are provided. All shades of EsCom250 are radio-opaque.
2026-04-21
EsCom250 - EsCom250 is the polymer-based dental restorative material. It can be light-cured intra orally for anterior and posterior restoration including occlusal surface. Various shades of A1, A2, A3, A3.5, A4, B1, B2, C2, D2, G1, AO2, AO3 and TW for esthetic restoration are provided. All shades of EsCom250 are radio-opaque.
2026-04-21
EsCom250 - EsCom250 is the polymer-based dental restorative material. It can be light-cured intra orally for anterior and posterior restoration including occlusal surface. Various shades of A1, A2, A3, A3.5, A4, B1, B2, C2, D2, G1, AO2, AO3 and TW for esthetic restoration are provided. All shades of EsCom250 are radio-opaque.
2026-04-21
EsCom250 - EsCom250 is the polymer-based dental restorative material. It can be light-cured intra orally for anterior and posterior restoration including occlusal surface. Various shades of A1, A2, A3, A3.5, A4, B1, B2, C2, D2, G1, AO2, AO3 and TW for esthetic restoration are provided. All shades of EsCom250 are radio-opaque.
2026-04-21
EsCom250 - EsCom250 is the polymer-based dental restorative material. It can be light-cured intra orally for anterior and posterior restoration including occlusal surface. Various shades of A1, A2, A3, A3.5, A4, B1, B2, C2, D2, G1, AO2, AO3 and TW for esthetic restoration are provided. All shades of EsCom250 are radio-opaque.
2026-04-21
EsCom250 - EsCom250 is the polymer-based dental restorative material. It can be light-cured intra orally for anterior and posterior restoration including occlusal surface. Various shades of A1, A2, A3, A3.5, A4, B1, B2, C2, D2, G1, AO2, AO3 and TW for esthetic restoration are provided. All shades of EsCom250 are radio-opaque.
2026-04-21
EsCom250 - EsCom250 is the polymer-based dental restorative material. It can be light-cured intra orally for anterior and posterior restoration including occlusal surface. Various shades of A1, A2, A3, A3.5, A4, B1, B2, C2, D2, G1, AO2, AO3 and TW for esthetic restoration are provided. All shades of EsCom250 are radio-opaque.
2026-04-21
EsCom250 - EsCom250 is the polymer-based dental restorative material. It can be light-cured intra orally for anterior and posterior restoration including occlusal surface. Various shades of A1, A2, A3, A3.5, A4, B1, B2, C2, D2, G1, AO2, AO3 and TW for esthetic restoration are provided. All shades of EsCom250 are radio-opaque.
2026-04-21
EsCom250 - EsCom250 is the polymer-based dental restorative material. It can be light-cured intra orally for anterior and posterior restoration including occlusal surface. Various shades of A1, A2, A3, A3.5, A4, B1, B2, C2, D2, G1, AO2, AO3 and TW for esthetic restoration are provided. All shades of EsCom250 are radio-opaque.
2026-04-21
EsCom250 - EsCom250 is the polymer-based dental restorative material. It can be light-cured intra orally for anterior and posterior restoration including occlusal surface. Various shades of A1, A2, A3, A3.5, A4, B1, B2, C2, D2, G1, AO2, AO3 and TW for esthetic restoration are provided. All shades of EsCom250 are radio-opaque.
2026-04-21
EsCom250 - EsCom250 is the polymer-based dental restorative material. It can be light-cured intra orally for anterior and posterior restoration including occlusal surface. Various shades of A1, A2, A3, A3.5, A4, B1, B2, C2, D2, G1, AO2, AO3 and TW for esthetic restoration are provided. All shades of EsCom250 are radio-opaque.
2026-04-21
EsCom250 - EsCom250 is the polymer-based dental restorative material. It can be light-cured intra orally for anterior and posterior restoration including occlusal surface. Various shades of A1, A2, A3, A3.5, A4, B1, B2, C2, D2, G1, AO2, AO3 and TW for esthetic restoration are provided. All shades of EsCom250 are radio-opaque.
2026-04-21
EsCom250 - EsCom250 is the polymer-based dental restorative material. It can be light-cured intra orally for anterior and posterior restoration including occlusal surface. Various shades of A1, A2, A3, A3.5, A4, B1, B2, C2, D2, G1, AO2, AO3 and TW for esthetic restoration are provided. All shades of EsCom250 are radio-opaque.
2026-04-21
EsTemp C&B - Hexa-Temp is temporary crown and bridge resin that is used temporarily before repairing a permanent restoration. It can be self-cured resin. Filler size ranges from 0.7 to 1.2 µm, resulting in good radio-opacity and high flexural strength.
2026-04-20
EsTemp C&B - Hexa-Temp is temporary crown and bridge resin that is used temporarily before repairing a permanent restoration. It can be self-cured resin. Filler size ranges from 0.7 to 1.2 µm, resulting in good radio-opacity and high flexural strength.
2026-04-20
EsTemp C&B - Hexa-Temp is temporary crown and bridge resin that is used temporarily before repairing a permanent restoration. It can be self-cured resin. Filler size ranges from 0.7 to 1.2 µm, resulting in good radio-opacity and high flexural strength.
2026-04-20
EsTemp C&B - Hexa-Temp is temporary crown and bridge resin that is used temporarily before repairing a permanent restoration. It can be self-cured resin. Filler size ranges from 0.7 to 1.2 µm, resulting in good radio-opacity and high flexural strength.
2026-04-20
EsTemp C&B - Hexa-Temp is temporary crown and bridge resin that is used temporarily before repairing a permanent restoration. It can be self-cured resin. Filler size ranges from 0.7 to 1.2 µm, resulting in good radio-opacity and high flexural strength.
2026-04-20
EsTemp C&B - Hexa-Temp is temporary crown and bridge resin that is used temporarily before repairing a permanent restoration. It can be self-cured resin. Filler size ranges from 0.7 to 1.2 µm, resulting in good radio-opacity and high flexural strength.
2026-04-20
EsTemp C&B - Hexa-Temp is temporary crown and bridge resin that is used temporarily before repairing a permanent restoration. It can be self-cured resin. Filler size ranges from 0.7 to 1.2 µm, resulting in good radio-opacity and high flexural strength. Various shades of TW, A1, A2, A3, B1, C2, AO3 and BL for esthetic crown are provided.
2026-04-20
FineEtch - FineEtch - 10, 37 is a phosphoric acid (H3PO4) semi-gel-type agent intended for use on dentin and enamel. FineEtch will effectively remove the smear layer and help successful bonding.
2026-04-20