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510(k) Data Aggregation
K Number
K240183Device Name
Star E900 Handpiece Series
Manufacturer
DentalEZ, Inc., StarDental Division
Date Cleared
2024-09-19
(240 days)
Product Code
EGS
Regulation Number
872.4200Why did this record match?
Applicant Name (Manufacturer) :
DentalEZ, Inc
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Star E900 Handpiece Series are intended to be used for general dentistry by trained dental professionals. The intended use of the respective handpieces is dependent on the gear ratio.
Star E900 1:5 Handpiece: the removal of decayed matter, cavity and crown preparations, the removal of fillings and surface finishing of tooth and restoration surfaces.
Star E900 1:1 Handpiece: Cavity preparations, caries excavation, endodontic applications, processing of tooth and restoration surfaces.
Star E900 5:1 Handpiece: Cavity preparations, caries excavation, endodontic applications, processing of tooth and restoration surfaces.
Star E900 1:1 Straight Handpiece: prophylaxis treatment, crown preparations, polishing of tooth and restoration surfaces
Device Description
The Star E900 Handpiece Series are reusable contra-angle handpieces, driven by an ISO 3964 compliant electric micro-motor or air driven motor, that are intended for use by trained dental professionals in the field of general dentistry. The Star E900 1:5, 1:1 and 5:1 handpieces are designed for general applications to prepare dental cavities for restoration. The Star E900 1:1 Straight Handpiece is designed for prophylaxis treatment, crown preparations, polishing finishing of tooth and restoration surfaces.
The Star E900 Handpiece Series feature an ISO 3964 compliant handpiece coupling connecting them to an electric micro-motor controlled by an electric control unit or air driven motor connected to a dental delivery unit. The control unit or delivery unit supplies energy to the handpiece which powers the gears within the handpieces. Depending on the applications, the handpieces have a maximum drive speed of 8,000 to 200,000 RPM's.
These handpieces are ergonomically shaped and have glass rod fiberoptics to illuminate the oral cavity during procedures. In addition, the handpieces have multi-port water spray. The exception to the fiber optics and water spray features is the Star E900 1:1 Straight Handpiece. This handpiece does not contain any fiberoptics nor does it have water spray capabilities.
All the handpieces in the Star E900 Handpiece series are composed of stainless steel and PEEK. They can be autoclaved.
The Star E900 Handpieces use only burs with hardened, tempered steel shanks or carbide shanks which are ISO 1797 compliant.
All handpieces in this series incorporate RFID (radio frequency identification) technology. This passive RFID tag does not have a built-in energy source. The RFID tag will allow the practitioner to track the device within the office only if the practitioner has a separate reader. The RFID reader will enable the practitioner to track such things as usage and maintenance.
The handpieces, with the exception of the Star E900 1:1 Straight Handpiece, incorporate a temperature sensor to be used in the service of the device, by trained service personnel, to access excessive heat in the handpiece, indicative of mechanical failure. This feature is not accessible to the practitioner.
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K Number
K192412Device Name
SD500 Elite LubeFree High Speed Handpiece, SD500 Elite Lubricated High Speed Handpiece, SD500 Pro LubeFree High Speed Handpiece, Pro Lubricated High Speed Handpiece
Manufacturer
DentalEZ, Inc.
Date Cleared
2020-01-06
(124 days)
Product Code
EFB
Regulation Number
872.4200Why did this record match?
Applicant Name (Manufacturer) :
DentalEZ, Inc
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The SD500 High Speed Handpiece Series is used by trained dental professionals for a variety of procedures including but not limited to caries and amalgam removal, restorative work and crown preparations.
Device Description
The SD500 High-Speed Handpiece Series includes a fiber optic high speed handpiece, to be marketed as a SD500 Elite Handpiece and a non-fiber optic handpiece, to be marketed as a SD500 Pro Handpiece. Both the Elite and the Pro versions are available as lubefree or lubricated turbine handpieces. Each is a pneumatically driven handheld device with multiport water spray that is capable of reaching rotational speeds of 367,200 – 448,800 rpms at a recommended air pressure of 38 to 43 PSI. The series delivers a range of 39 - 50 watts of power providing .28 oz.-in. of stall torque at 43 psi. The handpieces are constructed of stainless steel, including the internal air and water tubes, which provide drive air to the turbine assembly and cooling water to the work site. The handpiece also uses PEEK in its construction. The handpieces incorporate either a lubefree ceramic bearing turbine assembly or a lubricated ceramic bearing turbine assembly. Both versions of the turbine assembly use a push button autochuck. The stainless steel and aluminum air driven turbine assembly provides rotation to the bur. The SD500 High-Speed Handpiece Series uses a quick disconnect coupler that allows easy connection to the dental line delivery tubing. This coupler allows for easy rotation of the handpieces when attached to the tubing. These couplers include both fiber optic and nonfiber optic versions with Type 3 or 2 connections. The fiber optic version uses LED technology to deliver the light to the handpiece. All couplers are autoclavable. The burs used with the SD500 High Speed Handpiece Series are ISO 1797-1, type 2 burs. Only burs with hardened, tempered steel shanks or carbide shanks should be used. All handpieces in this series incorporate RFID (radio frequency identification) technology. This passive RFID tag does not have a built-in energy source. The RFID tag will allow the practitioner to track the device within the office only if the practitioner has a separate reader. A reader will enable the practitioner to track such things as usage and maintenance.
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K Number
K173465Device Name
Concentrix MX-AC High-Speed Handpiece
Manufacturer
DentalEZ, Inc.
Date Cleared
2018-03-28
(140 days)
Product Code
EFB
Regulation Number
872.4200Why did this record match?
Applicant Name (Manufacturer) :
DentalEZ, Inc
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Concentrix MX-AC High-Speed Handpiece is used by trained dental professionals for a variety of procedures including but not limited to caries and amalgam removal, restorative work and crown preparations.
Device Description
The Concentrix MX-AC High-Speed Handpiece is a pneumatically driven, non-fiber optic, 2/3 line fixed backend handpiece that is capable of reaching rotational speeds of 302,000 rpms at a recommended air pressure of 32 PSI. The handpiece is constructed of stainless steel, including the internal air and water tubes which provide drive air to the turbine assembly and cooling water to the work site. The stainless steel and aluminum air driven turbine assembly provides spin to the bur and incorporates steel lubricated bearings and a push button autochuck. The burs used with the Concentrix MX-AC High Speed Handpiece are ISO 1797-1, type 2 burs. Only burs with hardened, tempered steel shanks or carbide shanks should be used.
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K Number
K162397Device Name
Titan 3 Low Speed Angle Attachments
Manufacturer
DENTALEZ, INC
Date Cleared
2017-01-19
(146 days)
Product Code
EGS
Regulation Number
872.4200Why did this record match?
Applicant Name (Manufacturer) :
DENTALEZ, INC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Titan 3 Low Speed Angle Attachments are used intraorally by trained dental professionals for drilling and preparation of dental cavities for restoration, such as fillings, as well as disking, cavity and crown preps, polishing, post and pin drilling and pin setting.
Device Description
The proposed angles are attached to a pneumatically driven low speed motor via the use of either a motor-to-angle adaptor (K960260) or 16:1 contra angle (preamendment). Air supplied to the motor (K960260) drives a gearing system through the adaptor or contra angle to the angle attachment. A torque multiplier can be used between the motor and motor-to-angle adaptor or contra angle to reduce the rpms from the motor while increasing the torque. A dental bur is inserted into the angle to perform the procedure.
There are four different angle styles that will marketed under the names Titan 3 LubeFree Angles, Titan 3 Lubricated Angles, and Five Star Prophy Angles with some variations within each style. The main differences between the styles of the proposed angles are in the mechanical chucking mechanism of the angle and prophy, the composition of the outside plating of the angle attachment and the lubrication that may be needed to maintain the attachment.
The angles are constructed of brass, which is chrome plated The internal drive gears are constructed of stainless steel.
The lubricated angles, consisting of a ball bearing manual latch angle, ball bearing auto latch angle, ball bearing auto chuck friction grip angle and a Prophy angle require daily lubrication using the recommended lubricant, Dentalube II, which is manufactured by StarDental (K070869).
The lubefree angles, consisting of a ball bearing manual latch angle, ball bearing auto latch angle, ball bearing auto chuck friction grip angle and a Prophy angle, are lubricated during the assembly process and require no further lubrication by the user.
All proposed angles are autoclavable.
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K Number
K153411Device Name
430 Torque High-Speed Handpiece Series - 430 SWL Torque High Speed Handpiece, 430 SW Torque High Speed Handpiece
Manufacturer
DENTALEZ, INC.
Date Cleared
2016-04-08
(135 days)
Product Code
EFB
Regulation Number
872.4200Why did this record match?
Applicant Name (Manufacturer) :
DENTALEZ, INC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The 430 Torque High-Speed Handpiece Series are used by trained dental professionals for a variety of procedures including but not limited to caries and amalgam removal, restorative work and crown preparation.
Device Description
The 430 Torque High-Speed Handpiece Series consists of a fiber optic high speed handpiece, marketed as a SWL and a non-fiber optic handpiece, marketed as a SW handpiece. Each is a pneumatically driven hand- held device that is capable of reaching rotational speeds of 350,000 to 450,000 rpms at a recommended air pressure of 38-43 PSI. The series delivers on average up to 20 watts of power providing .269 oz.-in. of stall torque. The handpieces are constructed of stainless steel, including the internal air and water tubes which provide drive air to the turbine assembly and cooling water to the work site. The stainless steel and aluminum air driven turbine assembly provides spin to the bur, and incorporates lubefree ceramic bearings (K905155) and a push button autochuck. The rotor is larger than the rotor of the predicate, yielding a higher cutting torque. The fiber optics in the SWL version of the handpiece are lead-free, multi-core glass rod that transmit light from the fiber optic swivel coupler to the oral cavity. The 430 Torque High-Speed handpiece Series can be assembled to quick disconnect couplers that are ISO Type 3 and ISO Type 2 connections, available as fiber optic or non-fiber optic versions, using a halogen bulb or LED technology. All couplers are autoclavable with the exception of the LED coupler that incorporates the electronics internally.
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K Number
K113301Device Name
CONCENPIECE,HIGH-SPEED HANDPIECE SERIES
Manufacturer
DENTALEZ, INC.
Date Cleared
2012-01-23
(76 days)
Product Code
EFB
Regulation Number
872.4200Why did this record match?
Applicant Name (Manufacturer) :
DENTALEZ, INC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Concentrix High-Speed Handpieces are used by trained dental professionals for a variety of procedures including but not limited to caries and amalgam removal, restorative work and crown preparations.
Device Description
The Concentrix High-Speed Handpieces are pneumatically driven, hand-held devices used by trained dental professionals to perform a variety of dental procedures.
The Concentrix MX is a non-fiber optic, 2/3 line fixed backend handpiece with a steel bearing manual chucking turbine. The Concentrix PX is a non-fiber optic, 2/3 line fixed backend handpiece with a steel bearing, push button autochuck turbine. The Concentrix FX is a non-fiber optic, 3/4 line fixed backend handpiece with a steel bearing, push button autochuck turbine. The Concentrix SX is a fiber optic, swivel handpiece with a steel bearing, push button autochuck turbine.
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K Number
K093072Device Name
STARCARE HANDPIECE MAINTENANCE UNIT
Manufacturer
DENTALEZ, INC.
Date Cleared
2009-12-28
(89 days)
Product Code
EFB
Regulation Number
872.4200Why did this record match?
Applicant Name (Manufacturer) :
DENTALEZ, INC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The StarCare Handpiece Maintenance Unit is intended for the internal cleaning, i.e purging of old lubricant, and the lubrication of air-driven high speed handpieces, electric micromotor attachments and turbines used in dentistry.
StarCare Handpiece Maintenance Unit should be used only after the handpieces have been externally cleaned and prior to sterilization.
Device Description
The StarCare Handpiece Maintenance Unit is used for the cleaning, i.e. purging of old lubricant, and lubrication of lubricated high speed handpieces, electric micromotor attachments and handpiece turbines. The unit consists of two connections for high speed handpieces, one connection for electric micromotor attachments and one connection for handpiece turbine cleaning. The unit supplies cleaner and lubricant to the connection only when a high speed handpiece or electric micromotor attachment is present. The handpiece turbine cleaning function is independent of the high speed handpiece and electric micromotor attachment cleaning and lubrication function.
Two reservoirs within the unit supply the cleaner and lubricant to the individual stations. These reservoirs are clearly marked regarding the contents of the reservoir. The cleaner and lubricant are delivered to the high speed handpiece and electric micromotor attachment connection via tubes controlled by the activation of magnetic valves. The liquid is dispensed by pressurized air to the high speed handpiece and electric micromotor attachment.
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K Number
K070869Device Name
PROPHY STAR 3 HYGIENE HANDPIECE, MODEL 264422
Manufacturer
DENTALEZ, INC.
Date Cleared
2007-06-15
(78 days)
Product Code
EFB
Regulation Number
872.4200Why did this record match?
Applicant Name (Manufacturer) :
DENTALEZ, INC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The prophy handpiece is used by trained dental professionals to perform dental prophylaxis.
Device Description
The Prophy Star 3 Hygiene Handpiece is a low speed, pneumatically driven, hand-held device intended for use by trained dental professionals for performing dental prophylaxis. The handpiece uses either an ISO standard Doriot style reusable Prophy angle or a ISO standard Doriot style disposable angle. The Prophy Star 3 Hygiene Handpiece is a Lube Free handpiece requiring no lubrication.
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