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510(k) Data Aggregation
K Number
K250969Device Name
JET BITE; JET BLUE BITE FAST; JET BLUE BITE SUPERFAST
Manufacturer
Dent4You AG
Date Cleared
2025-06-27
(88 days)
Product Code
ELW
Regulation Number
872.3660Why did this record match?
Product Code :
ELW
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
JET BITE & JET BLUE BITE are intended for the registration of occlusion in cases where relationship between the relative positions of maxilla and mandible is required.
Device Description
Jet Bite and Jet Blue Bite are two component impression materials based on vinylpolysiloxanes used for the registration of occlusion between the maxilla and mandible. Jet Bite and Jet Blue Bite are mixed during application and applied directly to the teeth, after which the mandible is moved into centric occlusion making an impression.
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K Number
K241924Device Name
Elastic Impression Material
Manufacturer
Beijing OKVD Biological Technology Ltd.
Date Cleared
2024-12-27
(179 days)
Product Code
ELW
Regulation Number
872.3660Why did this record match?
Product Code :
ELW
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
An addition-cure vinyl polysiloxane dental impression material that is used for all crown and bridge, edentulous, orthodontic and implant impression techniques.
Device Description
The product is a kind of addition-cure silicon rubber impression material composed of vinyl polysiloxane and various fillers with neutral smell and applicable to impression in dentistry. This product is mainly composed of a matrix and a catalyst. The matrix is mainly composed of polydimethylsiloxane, vinyl silicone oil, methyl hydrogen polysiloxane, silica dioxide, ,calcium carbonate, and colorants. The catalyst is mainly composed of polydimethylsiloxane, silica dioxide, calcium carbonate, platinum catalyst, and colorants.
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K Number
K242360Device Name
Speedex Light Body; Speedex Medium; Speedex Putty; Speedex Putty Soft; Speedex Universal Activator
Manufacturer
Dent4You AG
Date Cleared
2024-11-15
(98 days)
Product Code
ELW
Regulation Number
872.3660Why did this record match?
Product Code :
ELW
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Speedex putty/putty soft
- Primary impression in the putty-wash Impression technique
- Pick-up impression in the simultaneous mixing technique
- Impressions for study models, orthodontic models, keys and protective isolation of teeth during fitting of prostheses
Speedex light body
- Correction material for the correction impression technique
- Syringe material for the two-phase impression technique
- Impression material for relining
Speedex medium
- Complete and partial prosthetics, correction material for the correction impression technique
- Monophase impression technique, simultaneous mixing technique
- Liner impression material
Speedex Universal Activator
- Activator for Speedex putty soft; Speedex light body; Speedex medium, for creating dental impressions
Device Description
Speedex is two-component impression material based on polysiloxanes. Speedex is intended for the recording of the current physical situation in a patient's mouth for the purpose of repairing, reshaping or replacing the patient's teeth. After mixing of a base and activator, the Speedex Materials form pastes which are used individually or in combination as antal impression material, usually together with a standard commerical or individual impression tray, using conventional impression techniques.
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K Number
K233954Device Name
Chemi-SiL (HB, MB, LB, LBS); Chemi-SiL Bite-Blu
Manufacturer
B&E Korea Co., Ltd.
Date Cleared
2024-02-13
(60 days)
Product Code
ELW
Regulation Number
872.3660Why did this record match?
Product Code :
ELW
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Chemi-SiL (HB, MB, LB, LBS) - Crown and bridge impression, inlay and onlay impressions
Chemi-SiL Bite-Blu - Impression of the occlusal surface
Device Description
Chemi-SiL of silicone impression materials are hydrophilic impression materials based on polyvinylsiloxane and it is used for impression of teeth or gingiva. It consists of three different consistencies (heavy body, light body, bite registration material) according to ISO 4823. And it is supplied base and catalyst in contrasting color. Each product is consisted of 1:1 base and catalyst component, packaged in two 50 mL catridges.
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K Number
K223892Device Name
DentMix VPS Impression Material
Manufacturer
Innovative Product Brands, Inc.
Date Cleared
2023-04-27
(120 days)
Product Code
ELW
Regulation Number
872.3660Why did this record match?
Product Code :
ELW
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
DentMix VPS Impression Material is intended for use with all crown and bridge, occlusal and implant impression techniques to reproduce the structure of a patient's teeth and gums.
Device Description
DentMix VPS Impression Material is an addition-reaction base/catalyst polyviny/siloxane dental impression material intended as an alternative to traditional alginate materials. It is available in regular set and fast set. Both are available in light body, regular body/monophase and heavy body.
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K Number
K213175Device Name
No Stress Impress
Manufacturer
No Stress Impress LLC
Date Cleared
2023-01-19
(478 days)
Product Code
ELW
Regulation Number
872.3660Why did this record match?
Product Code :
ELW
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
No Stress Impress is intended for use as a rebasing and relining impression material as well as for general impressions including but not limited to dentures, root surfaces, and posts.
Device Description
No Stress Impress is a thermoplastic impression material available for full or partial impressions that comes as a stick or wafer.
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K Number
K214086Device Name
Bright Impress-Light, Bright Impress-Medium, Bright Impress-Heavy, Bright Impress-Bite, Bright Impress-Putty
Manufacturer
Genoss Co., Ltd.
Date Cleared
2022-12-15
(353 days)
Product Code
ELW
Regulation Number
872.3660Why did this record match?
Product Code :
ELW
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Impression of inlay, onlay crown, and bridge preparation
- Crown, bridge impression
- Inlay and onlay impression
- Functional impression
- Denture impression
- Study model impression
Device Description
Bright Impress impression material is a fast-set of addition-reaction silicone elastomer (Vinyl polysiloxane)-based material for dental professionals, consisting of five types (Light, Medium, Heavy, Bite and Putty) with superior hydrophilicity, dimensional accuracy, high tensile strength, and resistant to deformation. It is designed for versatile impression techniques of crowns, bridges, orthodontics and implants.
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K Number
K222741Device Name
DENU Light Body(Regular, Fast), DENU Heavy Body(Regular, Fast), DENU Putty Set(Regular, Fast)
Manufacturer
HDI, Inc.
Date Cleared
2022-11-07
(59 days)
Product Code
ELW
Regulation Number
872.3660Why did this record match?
Product Code :
ELW
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
DENU Light Body(Regular, Fast) / DENU Heavy Body(Regular, Fast)
- Crown and bridge impression
- Inlay and onlay impression
- Denture impression
- Model impression
DENU Putty Set(Regular, Fast)
- Crown and bridge impression
- Inlay and onlay impression
Device Description
The DENU family of silicone impression materials consists of three different viscosities (light body, heavy body, putty) for various application systems. Products are further classified into Regular type and Fast type, depending on curing time, but there is no difference on viscosity, indications for use, or scope of use. Each device is consisted of 1:1 base and catalyst component, packaged in 560mL jars for DENU Putty set and 50mL syringes for other devices.
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K Number
K213244Device Name
Accusil Dental Impression Materials (Accusil Light Body Regular and Fast Set, Accusil Heavy Body Regular and Fast Set, Accusil Monophase Regular and Fast Set, Accusil Putty Regular and Fast Set, Accusil Bite Registration)
Manufacturer
Prevest Denpro Limited
Date Cleared
2022-09-09
(344 days)
Product Code
ELW
Regulation Number
872.3660Why did this record match?
Product Code :
ELW
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Accusil Dental Impression Material is intended to be placed on a preformed impression tray and used to reproduce the structure of a patient's teeth and gums.
Device Description
Accusil Dental Impression Materials are designed for dental applications to define and reproduce the structure of a patient's teeth and gums for producing crowns, bridges, occlusal models and dental implant restorative devices. Base and catalyst components are mixed in an equal ratio 1:1, placed into an impression tray and inserted into the patient's mouth. The material will conform to the patient's dentition and when set will produce a reproduction of the patient's teeth and occlusion.
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K Number
K221668Device Name
Dental Impression Material
Manufacturer
Chemoment Materials Co.,ltd
Date Cleared
2022-08-08
(61 days)
Product Code
ELW
Regulation Number
872.3660Why did this record match?
Product Code :
ELW
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Dental Impression Material is intended for use with all crowns, bridges, and orthodontic impression techniques to reproduce the structure of a patient's teeth and gums.
Device Description
The Dental Impression Material is a kind of addition-cure rubber impression material composed of vinyl polysiloxane and various fillers, with neutral smell and applicable to impression in dentistry.
The Dental Impression Material is very easy to mix and has good dimensional stability which helps to make precise impression taking.
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