(46 days)
Aseptico's AEU-925 VCT can be used for a wide range of dental procedures including;
-
Dental endodontic surgeries, such as drilling into the root canal.
-
General dentistry, such as removing carious material from the dentine.
-
Performing dental implant surgeries, such as perforating the bone, and tapping and threading procedures required before placement of implant prosthetics.
This programmable dental system digitally controls the speed, direction and torque of a low voltage dental motor. Each dental system has programmed into memory a library of speed and torque settings for commonly used Endodontic files and dental implants. The AEU-925 can also be programmed by the dentist to hold in memory six speed and torque settings that they prefer to use most. The speed and torque limiting features are intended to reduce overtightening of Endodontic files and dental implants.
List of features:
-
- Stores speed and torque settings in its "Library" that can be recalled later
-
- Allows the operator to select the "mode" of operation from either "Implant" or "Endodontic" operation.
-
- Has a built in dynamometer to calibrate the handbiece, motor and console prior to use.
-
- Uses the autoclavable motor AE-9A-30.
-
- Has a built in water pump to provide irrigation
-
- Allows connectivity to a personal computer to upload new settings,
-
- Foot control AE-19 can be used to activate water on/off, change forward/reverse direction of the drill, scroll through various presets that are in the program menu,
-
- Allows the operator to use voice commands to step through library of preset speed and torque values.
The provided document is a 510(k) summary for a dental handpiece and accessories device (Aseptico VCT Versatile Control Technology Model AEU-925). It describes the device's features, intended use, and indicates its substantial equivalence to previously marketed predicate devices. However, this document does not contain any information regarding acceptance criteria, performance studies, sample sizes, expert involvement, ground truth establishment, or any of the other specific details requested in your prompt regarding device performance and validation.
The 510(k) summary is a regulatory document to establish substantial equivalence for market clearance, not typically a detailed report on a device's performance validation against specific acceptance criteria.
Therefore, I cannot populate the table or answer your questions based on the provided text. The document states that the device "digitally controls the speed, direction and torque of a low voltage dental motor" and has "speed and torque limiting features intended to reduce overtightening of Endodontic files and dental implants," but it does not provide any quantitative data or studies to prove these claims against specific metrics.
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Aseptico Inc. 8333 216th St SE Woodinville, WA 98072 Telephone 425.487.315 Fax 360 668-8722 www.aseptico.com grant@aseptico.com
KO30163
510(k) Summary
MAR 0 3 2003
Grant Ramaley Contact:
Date Prepared: September 16, 2002
Trade or Proprietary Name: Aseptico VCT Versatile Control Technology Model AEU-925
Classification Name: 872.4200 Dental Handpiece and Accessories
Description of characteristics
This programmable dental system digitally controls the speed, direction and torque of a low voltage dental motor. Each dental system has programmed into memory a library of speed and torque settings for commonly used Endodontic files and dental implants. The AEU-925 can also be programmed by the dentist to hold in memory six speed and torque settings that they prefer to use most. The speed and torque limiting features are intended to reduce overtightening of Endodontic files and dental implants.
List of features:
-
- Stores speed and torque settings in its "Library" that can be recalled later
-
- Allows the operator to select the "mode" of operation from either "Implant" or "Endodontic" operation.
-
- Has a built in dynamometer to calibrate the handbiece, motor and console prior to use.
-
- Uses the autoclavable motor AE-9A-30.
-
- Has a built in water pump to provide irrigation
-
- Allows connectivity to a personal computer to upload new settings,
-
- Foot control AE-19 can be used to activate water on/off, change forward/reverse direction of the drill, scroll through various presets that are in the program menu,
-
- Allows the operator to use voice commands to step through library of preset speed and torque values.
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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is a stylized symbol that resembles three abstract human figures or birds in flight, arranged in a layered, overlapping manner.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR 0 3 2003
Aseptico, Incorporated C/O Mr. Charles Mack Responsible Third Party Official Underwriters Laboratories, Incorporated 2600 N. W. Lake Road Camas, Washington 98601-8542
Re: K030163
Trade/Device Name: Aseptico's AEU-925 VCT Versatile Command Technology Regulation Number: 872.4200 Regulation Name: Dental Handpiece and Accessories Regulatory Class: I Product Code: EKX Dated: February 13, 2003 Received: February 21, 203
Dear Mr. Mack:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
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Page 2 - Mr. Mack
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (301) 594-4613. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours.
Susan Roman
Susan Runner, DDS, MA Interim Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Page of
510(k) Number K030163
Dental Handpiece and Accessories Device Name:
Indications For Use:
Aseptico's AEU-925 VCT can be used for a wide range of dental procedures including;
-
Dental endodontic surgeries, such as drilling into the root canal.
-
General dentistry, such as removing carious material from the dentine.
-
Performing dental implant surgeries, such as perforating the bone, and tapping and threading procedures required before placement of implant prosthetics.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use سمد (Per CFR 801.109)
(Optional Format 1-2-96)
§ 872.4200 Dental handpiece and accessories.
(a)
Identification. A dental handpiece and accessories is an AC-powered, water-powered, air-powered, or belt-driven, hand-held device that may include a foot controller for regulation of speed and direction of rotation or a contra-angle attachment for difficult to reach areas intended to prepare dental cavities for restorations, such as fillings, and for cleaning teeth.(b)
Classification. Class I.