AHP-66 4:1 REDUCTION CONTRANGLE: AHP-88 8:1 REDUCTION CONTRANGLE: AHP-88MP 8:1 REDUCTION CONTRANGLE - PUSH BUTTON

K020137 · Aseptico, Inc. · EGS · Mar 4, 2002 · Dental

Device Facts

• Record ID: K020137
• Device Name: AHP-66 4:1 REDUCTION CONTRANGLE: AHP-88 8:1 REDUCTION CONTRANGLE: AHP-88MP 8:1 REDUCTION CONTRANGLE - PUSH BUTTON
• Applicant: Aseptico, Inc.
• Product Code: EGS · Dental
• Decision Date: Mar 4, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.4200
• Device Class: Class 1
• Attributes: Therapeutic

Intended Use

Aseptico's fully autoclavable handpieces are used for a wide range of dental procedures including; 1) Dental endodontic surgeries, such as drilling into the root canal. 2) General dentistry, such as removing carious material from the dentine. 3) Performing dental implant surgeries, such as perforating the bone, and tapping and threading procedures required before placement of implant prosthetics.

Device Story

Aseptico Autoclavable Handpieces are dental instruments used by dental professionals for intra-oral procedures. Devices receive rotational force input from electric micro-motors; internal geared components convert this force into specific bur speeds and torque. Gear ratios range from 1:1 to 256:1. Handpieces feature latch or push-button bur/file attachment mechanisms and are available in straight or angled configurations. Used in clinical settings for endodontic drilling, general restorative dentistry, and implant surgery. Devices are fully autoclavable to ensure sterility of internal components.

Clinical Evidence

Bench testing only. Validation performed by a third-party laboratory to confirm a sterility assurance level (SAL) of 10^-6 following specified steam autoclaving procedures.

Technological Characteristics

Dental handpieces compliant with ISO 7785-2. Features include geared components for speed/torque conversion (ratios 1:1 to 256:1), latch or push-button attachment mechanisms, and straight or angled form factors. Designed for steam autoclaving sterilization.

Indications for Use

Indicated for dental professionals performing endodontic surgeries, general dentistry (carious material removal), and dental implant surgeries (bone perforation, tapping, threading).

Regulatory Classification

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.

Submission Summary (Full Text)

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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 [phone] Fax [phone] www.aseptico.com [e-mail]

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

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° 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,
- 2) General dentistry, such as removing carious material from the dentine.
- 3) 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 [phone]. Additionally, for questions on the promotion and Office of Comphance at (301) see contact the Office of Compliance at [phone]. 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 [phone] 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;

1) Dental endodontic surgeries, such as drilling into the root canal.

2) General dentistry, such as removing carious material from the dentine.

3) 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 |
|------------------------------------|----|----------------------|
|------------------------------------|----|----------------------|

(Optional Format 1-2-96)