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Found 4 results
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?
Applicant Name (Manufacturer) :
Dent4You AG
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
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?
Applicant Name (Manufacturer) :
Dent4You AG
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
K240801Device Name
BioSonic US200 Ultrasonic Scaler (60034537)
Manufacturer
Dent4You AG
Date Cleared
2024-07-01
(98 days)
Product Code
ELC
Regulation Number
872.4850Why did this record match?
Applicant Name (Manufacturer) :
Dent4You AG
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Ultrasonic Applications for:
- All sub-gingival and supra-gingival scaling and routine prophylaxis procedures.
- Periodontal therapy
Device Description
The BioSonic US200 Ultrasonic Scaler is an ultrasonic scaling unit that is used in sub-gingival and supra-gingival scaling and routing prophylaxis procedures, and periodontal therapy. The BioSonic US200 Ultrasonic Scaler includes the main unit, handpiece, footswitch, removable sheath, and a selection of scaler inserts. This device generates high frequency waves that cause the tip of the scaler insert to vibrate at 25kHz or 30kHz depending on the scaler insert used.
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K Number
K223142Device Name
Coltolux Comfort LED Curing Light
Manufacturer
Dent4You AG
Date Cleared
2022-12-22
(79 days)
Product Code
EBZ
Regulation Number
872.6070Why did this record match?
Applicant Name (Manufacturer) :
Dent4You AG
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Coltolux Comfort LED Curing Light is indicated for the polymerization of intra- and extraoral dental restorations fabricated from materials (commonly referred to as visible light cured dental restoratives and/or composites and/or dental adhesives) that contain Camphorquinone as the photoinitiator.
Device Description
The proposed Coltolux Comfort LED Curing Light (Coltolux Comfort) is used for the polymerization of light-cured resin materials used in dental restorations. The Coltolux Comfort incorporates a focused high-power LED to produce light in the "deep blue" spectrum (wavelength 440 - 470 nm) for activating Camphorquinone (CQ) photo-initiators. The device is utilized by placement of the lens within close proximity to the surface of the material to be cured, activation of the curing light via the pushbutton switch, and retention of the tip near the dental material until the composite is cured.
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