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510(k) Data Aggregation
K Number
K250566Device Name
EsCem RMGI
Manufacturer
Spident Co., Ltd.
Date Cleared
2025-06-20
(114 days)
Product Code
EMA
Regulation Number
872.3275Why did this record match?
Applicant Name (Manufacturer) :
Spident Co., Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Final cementation of
- Metal inlays, onlays, crowns and bridges
- Resin inlays, onlays, crowns and bridges
- Ceramic inlays
- Zirconia crowns and bridges
- Metal, ceramic and fiber posts
Device Description
EsCem RMGI is a radiopaque resin modified glass ionomer luting cement corresponding to ISO 9917-2, Class 3. This product facilitates the removal of excess cement through the tack-cure option, allowing for quick treatment. The contents consisting of base and catalyst are provided in a dual syringe and are used to cement indirect restoration by mixing the two types of paste.
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K Number
K242702Device Name
VioSeal
Manufacturer
SPIDENT CO., LTD.
Date Cleared
2024-11-07
(59 days)
Product Code
KIF
Regulation Number
872.3820Why did this record match?
Applicant Name (Manufacturer) :
SPIDENT CO., LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Permanent obturation of root canals of the permanent teeth in combination with root canal points
Device Description
VioSeal is the epoxy resin-based root canal sealer in the dual syringe for easy mixing and injection and is mixed with the 1:1 mixing ratio. It contains inorganic fillers which has good biocompatibility, physical and chemical properties and produces a complete obturation. Therefore, VioSeal has good biocompatibility with the root canal tissues.
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K Number
K242675Device Name
FineEtch (FineEtch-10 1.2ml, FineEtch-10 5ml, FineEtch-37 1.2ml FineEtch-37 5ml, FineEtch 37% 1.2ml 20ea pack)
Manufacturer
Spident Co., Ltd.
Date Cleared
2024-11-01
(56 days)
Product Code
KLE
Regulation Number
872.3200Why did this record match?
Applicant Name (Manufacturer) :
Spident Co., Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
· Pretreatment etchant before resin (help to having a strong bonding strength between resin and teeth)
· Remove smear layer of dentin and enamel
• Pretreatment etchant before sealant (help to having a strong bonding strength between sealant and teeth)
Device Description
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.
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K Number
K241445Device Name
K-Bond Universal
Manufacturer
Spident Co., Ltd.
Date Cleared
2024-07-22
(61 days)
Product Code
KLE
Regulation Number
872.3200Why did this record match?
Applicant Name (Manufacturer) :
Spident Co., Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
-Bonding of all direct composite restorations
-Bonding of dual/self cure composite and core build-ups
-Repairs of composite fillings
-Root surface desensitization
Device Description
K-Bond Universal is a bonding system that offers exceptional bonding strength through a convenient single bottle application. This single-component bonding agent is specifically formulated to effectively bond various types of direct composite restorations to dentin, enamel, as well as composite.
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K Number
K231523Device Name
EsCom250
Manufacturer
Spident Co., Ltd.
Date Cleared
2023-07-24
(59 days)
Product Code
EBF
Regulation Number
872.3690Why did this record match?
Applicant Name (Manufacturer) :
Spident Co., Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
- Direct anterior and posterior restorations
- Restoration of fractured (broken) teeth due to trauma
- Restoration of deciduous teeth
- Direct restorative for diastema closure
Device Description
EsCom250 is the polymer-based dental restorative material. It can be light-cured intra orally for anterior and posterior restoration including occlusal surface. Filler size ranges from 16nm to 1.2 um. 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 radioopaque.
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K Number
K214076Device Name
EsCem
Manufacturer
SPIDENT CO., LTD.
Date Cleared
2022-12-19
(357 days)
Product Code
EMA
Regulation Number
872.3275Why did this record match?
Applicant Name (Manufacturer) :
SPIDENT CO., LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Final cementation of all-ceramic, metal-based inlays, onlays, posts, crown and bridge
Device Description
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, and 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(1.2mm Al). And it offers various shades for aesthetics and color stable.
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K Number
K214071Device Name
Hexa-Temp
Manufacturer
SPIDENT CO., LTD.
Date Cleared
2022-03-10
(73 days)
Product Code
EBG
Regulation Number
872.3770Why did this record match?
Applicant Name (Manufacturer) :
SPIDENT CO., LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Self-curing temporary crown resin that is used temporarily before repairing a permanent restoration
Device Description
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. Hexa-Temp contains about 38% inorganic filler. Inorganic filler has a size of 16nm ~ 3.22µm.
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K Number
K161774Device Name
i-Sil
Manufacturer
SPIDENT Co., Ltd.
Date Cleared
2016-09-30
(94 days)
Product Code
ELW
Regulation Number
872.3660Why did this record match?
Applicant Name (Manufacturer) :
SPIDENT Co., Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
- Impression material in a dual phase impression technique
- Precise duplication of models
- Capturing multiple unit impressions
Device Description
i-Sil is impression material. It has 5 types: Heavy, Medium, Light, Putty and Bite.
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K Number
K134022Device Name
BASE IT
Manufacturer
SPIDENT CO., LTD.
Date Cleared
2014-06-11
(163 days)
Product Code
EJK
Regulation Number
872.3250Why did this record match?
Applicant Name (Manufacturer) :
SPIDENT CO., LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Base it is a light-cured, radiopaque dental liner and base material that Contains calcium bydroxyl apatite in a urethane dimethacrylate oligomer. Base it is used to line cavity preparations before restoration.
Device Description
Base it is light-cured Cavity Liner. It is radiopaque cavity liner and base material specially formulated for use with adhesives, composites and conventional restorative materials. It has urethane dimethacrylate base and is similar in chemistry to dental composites.
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K Number
K134021Device Name
ESTEMP IMPLANT, ESTEMP CLEAR
Manufacturer
SPIDENT CO., LTD.
Date Cleared
2014-06-10
(162 days)
Product Code
EMA
Regulation Number
872.3275Why did this record match?
Applicant Name (Manufacturer) :
SPIDENT CO., LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
EsTemp Implant, EsTemp Clear is a non-eugenol temporary cement for luting implantretained crowns, bridges, inlays, onlay and splints.
Device Description
Estemp temporary resin cement series consists of EsTemp Implant & EsTemp Clear. Each is designed to be suitable for various applications such as cementing temporary crowns, bridges, inlays and splints. They are available in an automix dual barrel syringe. It is light-curing temporary filling materials
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