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.

Device Description

Aseptico's autoclavable handpieces are intended to be used by dental professionals for a broad range of intra-oral dental procedures. These handpieces integrate requirements specified in International Standard ISO 7785-2 "Dental handpieces - Part 2: Straight and geared angle handpieces". This standard describes in precise detail how dental handpieces are typically designed and should perform, including withstanding a minimum of 250 cycles of steam autoclaving.

Aseptico's autoclavable dental handpieces vary from one model to another in three fundamental ways: They have different gear ratios, different methods for attaching burs and files (latch or push button style), and may be either straight or angled. The most common and notable variation between Aseptico's handpieces are their gear ratios. Different handpiece ratios convert the same input rotational force of an electric micro-motor into different bur speeds and bur torque. Aseptico's handpieces use a different arrangement of geared components to obtain different ratios of input to output speeds. These ratios are represented by numbers ranging from 1:1 (no reduction) to a 256:1 reduction.

All Aseptico's dental handpieces are tested and validated by a third party laboratory to a sterility assurance level (SAL) of 10-6. Every handpiece is designed to ensure that the innermost, hardest to reach parts of the handpieces are sterile when following sterilization procedure included in the instructions for use.

AI/ML Overview

The provided text is a 510(k) summary for Aseptico Autoclavable Handpieces. It describes the device, its intended use, and states that it integrates requirements specified in international standard ISO 7785-2. It also mentions testing by a third-party laboratory for sterility assurance, but it does not contain information about acceptance criteria, specific study designs, sample sizes, expert involvement, or any performance metrics in the format requested.

Therefore, I cannot provide the detailed information requested in the table and subsequent points based on the provided text.

The document primarily focuses on:

Description of the Device: Dental handpieces with various gear ratios, bur attachment methods, and straight/angled designs.
Intended Use: Broad range of intra-oral dental procedures including endodontic surgeries, general dentistry (removing carious material), and dental implant surgeries (perforating bone, tapping/threading).
Compliance with Standards: Conforms to ISO 7785-2 (Dental handpieces - Part 2: Straight and geared angle handpieces) for design and performance, including withstanding a minimum of 250 cycles of steam autoclaving.
Sterilization: Tested by a third-party laboratory to a sterility assurance level (SAL) of 10⁻⁶.
FDA Clearance: A 510(k) premarket notification was reviewed, and the device was determined to be substantially equivalent to legally marketed predicate devices.

Summary

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K 020137

Image /page/0/Picture/1 description: The image shows the logo for "ASELTICO International". The word "ASELTICO" is written in a stylized font, with the letters overlapping each other. Below "ASELTICO" is the word "International" in a smaller, simpler font. To the right of the text is a graphic of the earth.

Aseptico Inc. 8333 216" St SE Woodinville, WA 98072

Telephone 425.487.3157 Fax 360 668-8722 www.aseptico.com grant@aseptico.com

MAR 4 2002

510(k) Summary

Contact: Grant Ramaley

Date Prepared: January 29, 2002

Trade or Proprietary Name: Aseptico Autoclavable Handpieces

Classification Name: D Dental handpieces and accessories (872.4200)

Description of handpiece characteristics

All Aseptico's dental handpieces are tested and validated by a third party laboratory to a sterility assurance level (SAL) of 10° Every handpiece is designed to ensure that the innermost, hardest to reach parts of the handpieces are sterile when following sterilization procedure included in the instructions for use.

Aseptico's fully autoclavable handpieces are used for a wide range of dental procedure including;

1. Dental endodontic surgeries, such as drilling into the root canal,
1. General dentistry, such as removing carious material from the dentine.
1. Performing dental implant surgeries, such as perforating the bone, and tapping and threading procedures required before placement of implant prosthetics.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/1/Picture/1 description: The image shows a circular logo with text around the perimeter and a stylized bird-like symbol in the center. The text around the circle reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA". The bird-like symbol in the center is composed of three curved lines that resemble feathers or wings.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 4 2002

Mr. Grant Ramaley Ouality Regulatory Affairs Manager Aseptico, Incorporated 8333 216th Street S.E. Woodinville. Washington 98072

Re: K020137

Trade/Device Name: Aspectico Autoclavable Handpieces Regulation Number: 872.4200 Regulation Name: Dental Handpiece and Accessories Regulatory Class: I Product Code: EGS Dated: January 11, 2002 Received: January 16, 2002

Dear Mr. Ramaley:

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.

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.

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Page 2 - Mr. Ramaley

You must comply with all the Act's requirements, including, but not limited to: registration 1 ou inust comply with a807); labeling (21 CFR Part 801); good manufacturing practice alla listing (21 CFR Part 007), labeling (21 CFR Part 820); and if requirences as set forum in the quality systems (Sections (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 This letter will and w you to began mailer of substantial equivalence of your device to 310(k) premarket notheation. The 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 If you desire specific as not 2019 10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613. Additionally, for questions on the promotion and Office of Comphance at (301) see contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under notheation (210) It Far 607159).
the Act may be obtained from the Division of Small Manufacturers, International and the Act may be obtained from the Driver of the Privation of (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

. Ulatowski Timothy Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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K020137

. :

Page__________________________________________________________________________________________________________________________________________________________________________

510(k) Number (if known) K020137

Dental Handpieces and Accessories Device Name:

Indications For Use:

Aseptico's fully autoclavable handpieces are 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)

(Division Sign-Off)
Division of Dental, Infection Control, and General Hospital Devices
K(K) Number	K020137

Prescription Use (Per CFR 801.109)	OR	Over-The-Counter Use
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(Optional Format 1-2-96)

Regulation Number and Section

§ 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.