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510(k) Data Aggregation

    K Number
    K213932
    Device Name
    A-dec 300, A-dec 500
    Manufacturer
    A-dec, Inc.
    Date Cleared
    2022-03-02

    (76 days)

    Product Code
    EIA
    Regulation Number
    872.6640
    Why did this record match?
    Applicant Name (Manufacturer) :

    A-dec, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The A-dec Delivery System is intended to provide a mounting location to providing arr, water, vacuum, and electrical power to dental devices for use during diagnostic treatment by licensed health care professionals. Delivery systems may be mounted to dental carts, dental cabinets, and walls.
    Device Description
    Not Found
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    K Number
    K133776
    Device Name
    A-DEC/W&H ELECTRIC HANDPIECE MOTOR
    Manufacturer
    A-DEC, INC.
    Date Cleared
    2014-05-28

    (167 days)

    Product Code
    EBW
    Regulation Number
    872.4200
    Why did this record match?
    Applicant Name (Manufacturer) :

    A-DEC, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The A-dec/W&H Electric Motor kit is a device system comprised of a control unit that drives a DC electric micromotor that is activated by means of a footswitch. It is intended for use in general dental applications such as: cutting a tooth for cavity preparation, crown preparation, crown finishing, inlay, filing, polishing, prophylaxis, and endodontic treatment, with use of a straight, right-angle, or contra-angle ISO E-type handpiece attachment of equal speed, gear-reduction speed, or gear-increasing speed.
    Device Description
    The A-dec/W&H Electric Motel EA-53 is designed to accommodate existing and new Alegra, Proxeo, Endea, and Synea handpiece attachments for the purpose of performing dental restoration procedures. When equipped with the electric micromotor, the handpiece attachments provide the same effective drive force as would be provided by existing air motors. The significant advantage to driving a handpiece with the electric micromotor is the near-constant torque applied by the electric brushless micromotor. With air motor drive, the handpiece will tend to stall in extreme torque situations. The near-constant torque applied by the electric micromotor results in a more uniform and efficient dental reduction of the operatory site. The electric micromotor is autoclavable. This system will be used in an integrated configuration on the dental operatory chair system. The motor controller is contained within the control head (dental unit) and acquires +24 VAC from the chair system 300W power supply secondary voltage output. The handpiece tubing extends from the control head to the ISO-E coupler. The micromotor is attached to the coupler on one end and attached on the other (output) end to a handpiece attachment suitable for the intended dental procedure. This system will include: Motor Controller, Electric Micromotor, Handpiece tubing with E-connector.
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    K Number
    K102234
    Device Name
    A-DEC 200 DENTAL SYSTEM
    Manufacturer
    A-DEC, INC.
    Date Cleared
    2010-11-24

    (107 days)

    Product Code
    EIA
    Regulation Number
    872.6640
    Why did this record match?
    Applicant Name (Manufacturer) :

    A-DEC, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The A-dec 200 Dental System and accessories are intended for use in general dental applications by providing the dental practitioner a user interface to control operation of the dental chair and attached dental devices. The system delivers air, water, vacuum and electricity to allow the dental practitioner an intuitive control center for all common and normal patient treatment procedures performed in the dental operatory.
    Device Description
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    K Number
    K100647
    Device Name
    A-DEC/W&H SYNEA SONIC SCALER HANDPIECE, MODELS ZA-55, ZA-55 L, ZA-55 LM, ZA-55M, SF1LM
    Manufacturer
    A-DEC, INC.
    Date Cleared
    2010-07-09

    (123 days)

    Product Code
    ELC
    Regulation Number
    872.4850
    Why did this record match?
    Applicant Name (Manufacturer) :

    A-DEC, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The A-dec/W&H ZA-55 Synea Sonic Scaler Handpiece Attachment is intended for use in dental treatment procedures. The pneumatically operated sonic device can be used, in conjunction with the appropriate tips, for the removal of supra and subgingival calculus, and teeth cleaning procedures.
    Device Description
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    K Number
    K082716
    Device Name
    A-DEC/W&H ALEGRA AIR-DRIVEN HIGHSPEED HANDPIECE, MODEL TE-97, TE-98, A-DEC/W&H ALEGRA HANDPIECE ATTACHMENT, MODEL HE-43
    Manufacturer
    A-DEC, INC.
    Date Cleared
    2009-01-15

    (120 days)

    Product Code
    EFB
    Regulation Number
    872.4200
    Why did this record match?
    Applicant Name (Manufacturer) :

    A-DEC, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The A-dec/W&H Alegra Air-Driven Highspeed Handpiece is an air-powered dental device. This device is designed for removing carious material and excess filling material, cavity and crown preparation, root canal preparations, finishing tooth preparations, restorations and polishing teeth. The A-dec/W&H Alegra Handpiece Attachment is powered by either an air-motor or electric motor and is intended for use in general dentistry. This device is designed for removing carious material and excess filling material, cavity and crown preparation, root canal preparations, finishing tooth preparations, restorations and polishing teeth.
    Device Description
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    K Number
    K082827
    Device Name
    A-DEC/W&H PROFIN RECIPROCATING CONTRA-ANGLE HANDPIECE ATTACHMENT
    Manufacturer
    A-DEC, INC.
    Date Cleared
    2009-01-07

    (104 days)

    Product Code
    EFB
    Regulation Number
    872.4200
    Why did this record match?
    Applicant Name (Manufacturer) :

    A-DEC, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The A-dec/W&H Synea Profin reciprocating contra-angle handpiece attachment is intended for use in removing protrusions or excess of filling materials and cements, preparation, finishing and polishing in the interdental and subgingival regions, stripping, vibrating of inlays using Dentatus tips and root canal preparations using endodontic files.
    Device Description
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    K Number
    K082985
    Device Name
    A-DEC 334/335 DELIVERY SYSTEM
    Manufacturer
    A-DEC, INC.
    Date Cleared
    2008-12-17

    (71 days)

    Product Code
    EIA
    Regulation Number
    872.6640
    Why did this record match?
    Applicant Name (Manufacturer) :

    A-DEC, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The A-dec 334/335 Delivery System Dental Unit and accessories are intended for use in general dental applications by providing the dental practitioner a user interface to control operation of the dental chair and attached dental devices. The system delivers air, water, vacuum and electricity to allow the dental practitioner an intuitive control center for all common and normal patient treatment procedures performed in the dental operatory.
    Device Description
    The A-dec 334/335 Delivery System Dental Unit and accessories are intended for use in general dental applications by providing the dental practitioner a user interface to control operation of the dental chair and attached dental devices. The system delivers air, water, vacuum and electricity to allow the dental practitioner an intuitive control center for all common and normal patient treatment procedures performed in the dental operatory.
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    K Number
    K070663
    Device Name
    A-DEC/W&H SYNEA AIR-DRIVEN HIGHSPEED HANDPIECE, MODEL TA-98, TA-97, A-DEC/W&H SYNEA HANDPIECE ATTACHMENT
    Manufacturer
    A-DEC, INC.
    Date Cleared
    2007-07-05

    (118 days)

    Product Code
    EFB
    Regulation Number
    872.4200
    Why did this record match?
    Applicant Name (Manufacturer) :

    A-DEC, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The A-dec/W&H Synea Air-Driven Highspeed Handpiece is an air-powered dental handpiece for use in general dentistry. This device is designed for removing carious material and excess filling material, cavity and crown preparation, root canal preparations, finishing tooth preparations, restorations and polishing teeth. The A-dec/W&H Synea Handpiece Attachment is powered by either an air-motor or electric micromotor for use in general dentistry. This device is designed for removing carious material and excess filling material, cavity and crown preparation, root canal preparations, finishing tooth preparations, restorations and polishing teeth.
    Device Description
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    K Number
    K051657
    Device Name
    A-DEC SELF-CONTAINED WATER SYSTEM
    Manufacturer
    A-DEC, INC.
    Date Cleared
    2005-08-30

    (70 days)

    Product Code
    EIA
    Regulation Number
    872.6640
    Why did this record match?
    Applicant Name (Manufacturer) :

    A-DEC, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The A-dec Self-Contained Water System with Antimicrobial AlphaSan" is intended for use in general dental applications by providing water to the dental syringe, various handpiece ancillary devices, and cuspidor cup-fill. When used according to manufacturer's instructions, and in conjunction with the cleaner tablet ICX", the Antimicrobial AlphaSan" contained in the bottle helps to reduce microbial contamination.
    Device Description
    A-dec Self-Contained Water System
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    K Number
    K032757
    Device Name
    A-DEC SELF-CONTAINED WATER SYSTEM, MODEL 0.7 LITER BOTTLE & 2 LITER BOTTLE
    Manufacturer
    A-DEC, INC.
    Date Cleared
    2003-12-10

    (96 days)

    Product Code
    EIA
    Regulation Number
    872.6640
    Why did this record match?
    Applicant Name (Manufacturer) :

    A-DEC, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The A-dec Self-Contained Water System is intended for use in providing water to the dental syringe, various handpiece devices, and cuspidor cup-fill. The system allows for flushing and waterline maintenance to help prevent contamination and maintain clean dental unit waterlines.
    Device Description
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