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Found 13 results
510(k) Data Aggregation
K Number
K150129Device Name
AEU-7000L-70V IMPLANT/ENDODONTIC DENTAL SYSTEM (LIGHTED VERSION)
Manufacturer
Aseptico, Inc.
Date Cleared
2015-05-28
(127 days)
Product Code
EKX
Regulation Number
872.4200Why did this record match?
Applicant Name (Manufacturer) :
Aseptico, Inc.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The AEU-700L-70V is a drive system for instruments and tools used in dentistry for implants / surgical and endodontic procedures. The system includes an irrigation supply and a wide range of user controls designed to provide drilling during osteotomy preparation and implant placement, or endodontic therapy.
Device Description
Not Found
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K Number
K142124Device Name
AEU-6000 IMPLANT / ENDODONTIC DENTAL SYSTEM
Manufacturer
ASEPTICO, INC.
Date Cleared
2014-12-31
(149 days)
Product Code
EKX
Regulation Number
872.4200Why did this record match?
Applicant Name (Manufacturer) :
ASEPTICO, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The AEU-6000-70V and AEU-6000 are drive systems for instruments and tools used in dentistry for implants/surgical procedures and endodontic procedures. The systems include an irrigation supply and a wide range of user controls designed to provide drilling during osteotomy preparation and implant placement or endodontic therapy.
Device Description
drive systems for instruments and tools used in dentistry for implants/surgical procedures and endodontic procedures. The systems include an irrigation supply and a wide range of user controls designed to provide drilling during osteotomy preparation and implant placement or endodontic therapy.
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K Number
K130693Device Name
AEU-525 TRANSPORT III PORTABLE DENTAL SYSTEM
Manufacturer
ASEPTICO, INC.
Date Cleared
2013-08-14
(153 days)
Product Code
ELC, EIA, EKX
Regulation Number
872.4850Why did this record match?
Applicant Name (Manufacturer) :
ASEPTICO, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
To be used for endodontic and general dentistry applications.
Device Description
Not Found
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K Number
K111078Device Name
AEU-26L ELCTRONIC ENDODONTIC SYSTEM
Manufacturer
ASEPTICO, INC.
Date Cleared
2011-06-14
(57 days)
Product Code
EKX
Regulation Number
872.4200Why did this record match?
Applicant Name (Manufacturer) :
ASEPTICO, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
For use in a wide range of dental procedures including; endodontic surgeries, such as drilling in to the tooth canal, and general dentistry, such as removing carious material from the dentin.
Device Description
Model Number: AEU-26L
Classification Name: 872.4200 Dental handpiece and accessories
Product Code: EKX handpiece, direct drive, ac-powered
Primary accessories exclusive to the AEU-26L system:
- a) AEU-26L Consol (Controller)
- b) AE-250L-30 Low Voltage Electric Motor
- c) On/Off Foot Pedal
- d) Motor holder attaching bracket
The AEU-26L is software controlled and has the following features:
- a) Allows adjustment of the motor speed from 300 to 30,000 RPM
- b) Allows setting the torque applied to the motor in gram/cm
- c) Allows selection of gear ratios for different geared E-Type handpieces
- d) Allows selection of forward or reverse drive rotation
- e) Allows reciprocating drive (forward/reverse cycling)
- Allows use of a foot pedal control to operate the attached handpiece motor
- Allows the user to define their own presets for speed (RPM) and torque (gram g)
- h) Allows for attaching geared handpieces that include optics for a light.
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K Number
K101332Device Name
AMC-20 PORTABLE DENTAL CART MODEL AMC-20
Manufacturer
ASEPTICO, INC.
Date Cleared
2011-04-11
(334 days)
Product Code
EIA
Regulation Number
872.6640Why did this record match?
Applicant Name (Manufacturer) :
ASEPTICO, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The AMC-20 is a self-contained mobile dental cart that is used for general dentistry and endodontic applications.
Device Description
AMC-20 Mobile Dental Cart
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K Number
K103399Device Name
GENERAL DENISTRY MOTOR
Manufacturer
ASEPTICO, INC.
Date Cleared
2011-02-28
(101 days)
Product Code
EKX
Regulation Number
872.4200Why did this record match?
Applicant Name (Manufacturer) :
ASEPTICO, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Can be used for a wide range of dental procedures including endodontic surgeries, such as drilling into the root canal, and general dentistry, such as removing carious material from the dentin.
Device Description
Not Found
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K Number
K070866Device Name
ASC-12 PIEZOELECTRIC SCALER
Manufacturer
ASEPTICO, INC.
Date Cleared
2007-04-11
(13 days)
Product Code
ELC
Regulation Number
872.4850Why did this record match?
Applicant Name (Manufacturer) :
ASEPTICO, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The ASC-12 is an ultrasonic scaler that is intended for the following procedures:
Scaling:
Interdentium treatment
Tooth neck and subgingival treatment
Treatment of large dental calculi
Treatment of coatings and tobacco stains
Treatment of periodontal pockets
Interproximal treatment
Loosening of crowns and posts
Endodontics:
Pulp Chamber Cleaning
Canal filling by ultrasonic gutta-percha condensation
Device Description
The ASC-12 is an AC mains-powered piezoelectric ultrasonic scaler intended for scaling and endodontic procedures. The device consists of a console, a footswitch and an autoclavable handpiece with interchangeable and autoclavable scaling tips.
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K Number
K051077Device Name
E-TYPE STRAIGHT HANDPIECE, MODEL AHP-101
Manufacturer
ASEPTICO, INC.
Date Cleared
2005-05-03
(6 days)
Product Code
EGS
Regulation Number
872.4200Why did this record match?
Applicant Name (Manufacturer) :
ASEPTICO, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The AHP-101 fully autoclavable, straight, 1:1 ratio E-Type dental handpiece is intended for use in general dentistry procedures, such as removing carious material from the dentine.
Device Description
The AHP-101 is a straight, fully autoclavable, 1:1 ratio E-Type dental handpiece intended for use in general dentistry procedures. It accepts standard 2.35mm (3/32") burs and may be used with prophy angles.
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K Number
K050201Device Name
AEU-14CF EXPENDITION
Manufacturer
ASEPTICO, INC.
Date Cleared
2005-03-18
(49 days)
Product Code
EIA
Regulation Number
872.6640Why did this record match?
Applicant Name (Manufacturer) :
ASEPTICO, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The EXPEDITION offers the dental professional the capability of carrying a complete dental operative system in one transportable case. The system is suitable for performing general dental procedures anywhere there is a suitable surface to contain and be operated on internal power source. Additionally, the internal power source can be recharged using a detachable solar panel.
Device Description
The AEU-14CF Expedition is a portable electric dental system intended to provide basic dentistry capabilities in emergency and field situations. The Expedition features an "E" type autoclavable 30,000 RPM brushless micro motor with interchangeable headpieces, a 3-way air/water syringe, a self-contained water system, and an oil-less air compressor. The Expedition is powered by internal 27.6V battery packs, and may be connected to a 120V/230V AC power source or to a 12/24V vehicle battery for extended operation or recharging. A detachable solar panel is also provided for recharging the internal batteries when other sources are not available.
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K Number
K030895Device Name
ASEPTICO ENDOPEX V, MODEL AEU-40
Manufacturer
ASEPTICO, INC.
Date Cleared
2003-12-03
(257 days)
Product Code
LQY
Regulation Number
N/AWhy did this record match?
Applicant Name (Manufacturer) :
ASEPTICO, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Endopex V is used to estimate the position an endodontic file in the root canal. The devices enhances endodontic surgery by enabling the dentist to reduce the number of required radiographs.
Device Description
Using two electrodes, electrical impedance is measured between a root canal file positioned inside the tooth and another making contact with the oral cavity along the lip. The software inside the Endopex V compares the impedance values being read between its two electrodes with impedance values stored in its software database. The comparison of impedance values are than converted to readings on the LED to indicate the estimated position of the endodontic file in relation to the inside root canal and the Apical Foramen.
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