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Found 22 results
510(k) Data Aggregation
K Number
K213932Device Name
A-dec 300, A-dec 500
Manufacturer
A-dec, Inc.
Date Cleared
2022-03-02
(76 days)
Product Code
EIA
Regulation Number
872.6640Why 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
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K Number
K133776Device Name
A-DEC/W&H ELECTRIC HANDPIECE MOTOR
Manufacturer
A-DEC, INC.
Date Cleared
2014-05-28
(167 days)
Product Code
EBW
Regulation Number
872.4200Why 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
K102234Device Name
A-DEC 200 DENTAL SYSTEM
Manufacturer
A-DEC, INC.
Date Cleared
2010-11-24
(107 days)
Product Code
EIA
Regulation Number
872.6640Why 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
K100647Device 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
872.4850Why 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
K082716Device 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
872.4200Why 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
K082827Device 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
872.4200Why 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
K082985Device Name
A-DEC 334/335 DELIVERY SYSTEM
Manufacturer
A-DEC, INC.
Date Cleared
2008-12-17
(71 days)
Product Code
EIA
Regulation Number
872.6640Why 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
K070663Device 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
872.4200Why 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
K051657Device Name
A-DEC SELF-CONTAINED WATER SYSTEM
Manufacturer
A-DEC, INC.
Date Cleared
2005-08-30
(70 days)
Product Code
EIA
Regulation Number
872.6640Why 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
K032757Device 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
872.6640Why 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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