(47 days)
Not Found
K/DEN, K/DEN
No
The description focuses on mechanical design, sterilization, and adherence to standards, with no mention of AI or ML.
Yes
The device is used for a wide range of dental procedures including endodontic surgeries, general dentistry, and dental implant surgeries, which are therapeutic interventions.
No
The device, Aseptico's autoclavable handpieces, is surgical equipment used for various dental procedures like drilling and removing material, not for diagnosing conditions.
No
The device description clearly describes physical dental handpieces with mechanical components (gears, bur attachment methods) and mentions physical testing for sterility and compliance with a hardware standard (ISO 7785-2). There is no mention of software as the primary or sole component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health. This testing is performed outside of the body (in vitro).
- Device Function: The description clearly states that Aseptico's handpieces are used for intra-oral dental procedures. They are tools used directly on the patient's teeth, bone, and root canals.
- Intended Use: The intended use is for performing physical procedures within the mouth, not for analyzing biological samples.
The device is a surgical/dental instrument used for mechanical manipulation within the oral cavity.
N/A
Intended Use / 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.
Product codes
EGS
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
intra-oral, root canal, dentine, bone
Indicated Patient Age Range
Not Found
Intended User / Care Setting
dental professionals
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
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
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;
-
- 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.
1
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.
2
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
3
. :
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 |
|---|---|---|
| ------------------------------------ | ---- | ---------------------- |
(Optional Format 1-2-96)