(83 days)
Not Found
Not Found
No
The summary describes a mechanical dental handpiece with a dust shield mechanism. There is no mention of AI, ML, image processing, or data analysis that would indicate the use of such technologies.
No
The device is described as an "Air Turbine Handpiece" used for high-speed cutting in general dental applications, such as crown and cavity preparation. Its primary function is mechanical cutting, not direct treatment or cure of a disease or condition. While it has a feature to reduce bacterial contamination, this is a secondary benefit related to hygiene and safety during a procedure, not a therapeutic action itself.
No
The device is described as an "Air Turbine Handpiece" intended for high-speed cutting in general dental applications, such as preparing teeth for crowns or cavities. It is a surgical/procedural tool, not a diagnostic one.
No
The device description clearly states "Air Turbine Handpiece, Mach-Sigma Ultra Push," which is a physical hardware device used in dentistry. The description of its function (high speed cutting, dust shield mechanism) further confirms it is a hardware device, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Intended Use: The intended use of this device is for general dental applications involving cutting teeth and removing dental materials. This is a mechanical procedure performed directly on the patient's tooth, not a test performed on a sample outside the body.
- Device Description: The device is described as an "Air Turbine Handpiece," which is a tool used for mechanical cutting.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, detecting biomarkers, or providing diagnostic information based on laboratory testing.
Therefore, this device falls under the category of a dental surgical or cutting instrument, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The device is intended for use in general dental applications, where high speed cutting is required. such as cutting a tooth for crown preparation, cavity preparation, removing metal crown or fillings. In addition to above Indication of Use, we would like to emphasize, as a USA-patented, long proven dust shield mechanism, Clean-Head System, is used as an integral part of the nurbine cartridge, that this device is able to substantially reduce bacterial contamination of the handpiece exhaust air lines to the dental unit.
Product codes
EFB
Device Description
Not Found
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Not Found
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
Image /page/0/Picture/1 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is a stylized caduceus, a symbol of medicine, with a single snake winding around a staff. The caduceus is composed of three wavy lines that form the shape of a snake and staff.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 10 1999
Mr. Hiroji Sekiguchi Marketing Manager-North America Official Correspondent Nakanishi, Incorporated 340 Kamihinata, Kanuma-Shi, Tochiqi-Ken 322 JAPAN
Re : K991701 Mach-Sigma Handpiece, Ultrapush, Models Trade Name: Mach-Sigma MU (Mini Head) Requlatory Class: I Product Code: EFB Dated: May 17, 1999 Received: May 19, 1999
Dear Mr. Sekiguchi:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of
1
Page 2 - Mr. Sekiguchi
the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
This letter will allow you to begin marketing your device as described in your 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 requlation (21 CFR Part 801 and additionally 809.10 for in xitro diaqnostic devices), please contact the Office of Compliance at (301) 594-4692. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance Also, please note the regulation entitled, at (301) 594-4639. "Misbranding by reference to premarket notification" (21 CFR Other general information on your responsibilities under 807.97). the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (1800) 638-2041 or (301) 443-6597
or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Timothy A. Ulatowski
Director
Division of Dental, Infection Control, and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
510(k) Number (if known):_K 9 9 170 (
Device Name: Air Turbine Handpiece, Mach-Sigma Ultra Push
Indications For Use:
The device is intended for use in general dental spplications, where high speed cutting is required. such as cutting a tooth for crown preparation, cavity preparation, removing metal crown or fillings.
In addition to above Indication for Use, we would like to emphasize, as a USA-patented, long proven dust shield mechanism, Clean-Head System, is used as an integral part of the nurbine cartridge, that this device is able to substantially reduce bacterial contamination of the handpiece exhaust air lines to the dental unit.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Susan Rummer
(Division Sign-Off) Division of Dental, Infection Control, and General Hospital Devices 510(k) Number.
Prescription Use (Per 21 CFR 801.109) OR
Over-The-Counter Use
(Optional Format 1-2-96)
9