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510(k) Data Aggregation
K Number
K242530Device Name
HF-Etchant Hydrofluoric Acid Etching Gel
Manufacturer
Rizhao HuGe Biomaterials Company, Ltd.
Date Cleared
2024-12-20
(116 days)
Product Code
KLE, EIH, PME
Regulation Number
872.3200Why did this record match?
Product Code :
KLE
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Used for extraoral etching of various types of resin bonded porcelain/ceramic restorations (veneers, crowns, and inlays) prior to the bonding and cementation procedure.
Device Description
HF-Etchant Hydrofluoric Acid Etching Gel is composed of water, hydrofluoric acid, thickening agent and pigment. It is a water soluble and miscible flowable gel. Using a disposable dispensing tip, the Hydrofluoric acid etching gel can be directly applied onto the porcelain/ceramic surface. Its color is red, which can be identified easily on tooth or a repairing surface with contrast. HF-Etchant Hydrofluoric Acid Etching Gel is delivered in syringes.
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K Number
K242749Device Name
TopCEM Ceramic Primer Ceramic Coupling Agent
Manufacturer
Rizhao HuGe Biomaterials Company, Ltd.
Date Cleared
2024-11-08
(57 days)
Product Code
KLE, EMA
Regulation Number
872.3200Why did this record match?
Product Code :
KLE
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
TopCEM Ceramic Primer Ceramic Coupling Agent serves as priming agent and is used to create a durable adhesion between luting composites and glass/oxide ceramic, metal, composite and fiberreinforced composite restorations.
Device Description
TopCEM Ceramic Primer Ceramic Coupling Agent is common oral cementation repair auxiliary materials. In the process of using the product, TopCEM Ceramic Primer Ceramic Coupling Agent is placed between the prosthesis and resin adhesives, which can form the bonding layer of tooth tissue - light cure dental adhesive layer - resin cement layer - ceramic coupling agent - prosthesis, so as to achieve better bonding effect. TopCEM Ceramic Primer Ceramic Coupling Agent does not have direct contact with tooth tissue during use. TopCEM Ceramic Primer Ceramic Coupling Agent is mainly composed of silane coupling agent, acid acrylate and volatile organic solvent.
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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?
Product Code :
KLE
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
K240153Device Name
Ceramic Etchant (HF-5 and HF-9)
Manufacturer
Liaoning Upcera Co., Ltd
Date Cleared
2024-10-02
(257 days)
Product Code
KLE, EIH, PME
Regulation Number
872.3200Why did this record match?
Product Code :
KLE
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Ceramic Etchant is intended for etching the porcelain veneers, crowns, and inlays extraorally. It is also used for pretreating the porcelain veneers, crowns, and inlays extraorally before bonding.
Device Description
Not Found
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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?
Product Code :
KLE
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
K241056Device Name
Light Cure Adhesive
Manufacturer
Sincera Technology (Changchun) Co., Ltd.
Date Cleared
2024-07-16
(89 days)
Product Code
KLE
Regulation Number
872.3200Why did this record match?
Product Code :
KLE
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Light Cure Adhesive can be used as a strict self-etch dental bonding agent, or in combination with the traditional total etch or enamel etch procedures:
- Direct bonding under a light-cured composite or compomer fillings/resin modified glass ionomer restoratives;
- Repair of dental restorations of ceramic, composites and/or metal alloys;
- Indirect dental restoration applications in combination with resin cement for cementation of all sorts of dental restorations including crowns, bridges, inlays/onlays, veneers, dental posts and other restorations made from materials of metals/alloys, metal-ceramic and/or porcelain, composites, and their combinations.
Device Description
Not Found
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K Number
K240743Device Name
Peak Universal Bond
Manufacturer
Ultradent Products, Inc.
Date Cleared
2024-03-20
(2 days)
Product Code
KLE
Regulation Number
872.3200Why did this record match?
Product Code :
KLE
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Use for virtually all etching and bonding needs in restorative dentistry for patients of all ages. Peak Universal Bond is used for desensitizing/sealing of tooth structure.
Peak Universal Bond adhesive bonds to the following materials:
- · Dentin and Enamel
- · Porcelain, Zirconia
- Metal
- · Composite
Device Description
Peak™M Universal Bond is a bottle, syringe, or unit dose delivered bonding resin. It can be used with selfetch or with total etch techniques. It is 7.5% filled with an ethyl alcohol solvent carrier and will cure with most high intensity lights including LEDs. Peak Universal Bond adhesive contains 0.2% chlorhexidine which may ensure long term bond strengths. Its mode of action produces a mechanical occlusion of dentin tubules by the resins, thus reducing tooth hypersensitivity.
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K Number
K231039Device Name
CLEARFIL Universal Bond Quick 2
Manufacturer
Kuraray Noritake Dental Inc.
Date Cleared
2023-12-13
(245 days)
Product Code
KLE
Regulation Number
872.3200Why did this record match?
Product Code :
KLE
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
- [1] Direct restorations using light-cured composite resin
- [2] Sealing of a prepared cavity or abutment tooth as a pretreatment for indirect restorations
- [3] Treatment of exposed root surfaces
- [4] Treatment of hypersensitive teeth
- [5] Intraoral repairs of fractured restorations
- [6] Post cementation and core build-ups
- [7] Cementation of indirect restorations
Device Description
CLEARFIL Universal Bond Quick 2 consists of BOND and K-ETCHANT Syringe. BOND is a light-cure bonding agent that allows for the treatment of dentin, enamel, and prosthetic materials. Depending on the indication, BOND is used as self-etching or with K-ETCHANT Syringe for selective enamel etching or total-etching procedures. BOND is intended to be used for both direct and indirect restorations. CLEARFIL DC Activator activates the dual-curing mechanism of BOND; however, the addition of CLEARFIL DC Activator to the adhesive is not required when using BOND with CLEARFIL DC CORE PLUS, self-adhesive resin cements manufactured by Kuraray Noritake Dental Inc. (Kuraray's self-adhesive cements, e.g. PANAVIA SA Cement Universal) or PANAVIA Veneer LC. K-ETCHANT Syringe is an etching gel that consists of 35 % phosphoric acid aqueous solution and colloidal silica.
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K Number
K232978Device Name
DX. Bond V Dental Bonding Adhesive
Manufacturer
Sino-Dentex Co., Ltd.
Date Cleared
2023-09-22
(366 days)
Product Code
KLE
Regulation Number
872.3200Why did this record match?
Product Code :
KLE
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
1.Bonding for all Classes of direct composite restoration 2.Bonding for indirect procedures involving metal, porcelain, and composite
Device Description
DX. Bond V Dental Bonding Adhesive is a multi-purpose dental bonding adhesive for all classes of direct composite restoration as well as for indirect procedures involving metal, porcelain and composite. DX. Bond V is also used for amalgam, self- cure composite and orthodontic brackets bonding. DX. Bond V consists of methylmethacrylates and solvent. After applied to bonding area with thin layer, methylmethacrylates are initiated by free radical with blue light and then polymerized to form cross-linking polymer network resulting in solid and strong bonding membrane. The adhesive is dropped onto a mixing pad before application.
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K Number
K231696Device Name
Fusion Bond 5, Fusion Bond 7, Fusion Bond DC, Renew MDP, Renew Universal
Manufacturer
Prevest Denpro Limited
Date Cleared
2023-08-11
(60 days)
Product Code
KLE
Regulation Number
872.3200Why did this record match?
Product Code :
KLE
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Fusion Bond 5 is indicated for direct composite or compomer restorations, adhesive cementation, and composite repair.
Fusion Bond 7 is indicated for bonding of composites to tooth structure, core build up, and adhesive cementation of crown & bridges, including inlays and onlays.
Fusion Bond DC is indicated for direct light cure composite or compomer restorations, core build up, and adhesive cementation of crown & bridges, including inlays and onlays.
Renew MDP is indicated for bonding of dual cure, light cure or self cure composite or compomer restorations to tooth structure. treatment of hypersensitive teeth, and intraoral repairs of fractured restorations.
Renew Universal is indicated for direct bonding of light-cured compomers to tooth structure, bonding of dual-cured core build up composites to tooth structure as long as these materials are light-cured. intraoral repair of composite, metal-based and zirconia /alumina-based restorations, intraoral repair of ceramic restorations in combination with a silane coupling agent, treatment of hypersensitive teeth, and cavity sealing as a pretreatment for indirect restorations.
Device Description
Prevest Denpro Tooth Bonding Agents attach different types of restorations to teeth.
Fusion Bond 5 is a light curing single component bonding agent. It primes and bonds in one step to attach restorations of composites, copomers, amalgams, and porcelains to tooth structures. Tooth structures should have a 37% phosphoric acid etchant application of Fusion Bond 5.
Fusion Bond 7 is a light curing single component bonding agent. It etches, primes, and bonds in one step to attach restorations of composites, copomers, amalgams, and porcelains to tooth structures.
Fusion Bond DC is a dual cure bonding direct and indirect restorations. Enamel and dentin surfaces should be conditioned with 37% phosphoric acid etchant before application of Fusion Bond DC. It is a two component adhesive with bonding agent and activator.
Renew MDP is a light curing single component bondines etching, priming and bonding in one bottle. It is an ethanol-water based dental adhesive containing 10-Methacryloyloxydececyl Dihydrogen Phosphate (10-MDP) a functional monomer which helps in bonding to dentin and cut and un-cut enamel. Renew MDP works with light-cured and dual-cured composite materials.
Renew Universal is a light curing single component bondines etching, priming and bonding. Renew Universal contains a combination of functional monomers such as 10-MDP and 4-META. Renew Universal works with light-cured and dual-cured composite materials.
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