(140 days)
Not Found
Not Found
No
The summary describes a mechanical dental handpiece with a check valve and does not mention any computational or data-driven features indicative of AI/ML.
No.
The device is an air turbine handpiece intended for dental cutting procedures, which are interventional rather than therapeutic. Its function is to perform mechanical tasks (cutting, removing material) not to treat, cure, or prevent disease.
No
Explanation: The device is described as an "Air Turbine Handpiece" used for high-speed cutting in general dental applications, such as crown and cavity preparation, and removing crowns or fillings. Its function is to perform physical alterations to teeth, not to diagnose conditions.
No
The device description clearly identifies it as an "Air Turbine Handpiece," which is a physical hardware device used in dentistry. The description of the check valve further confirms it is a hardware component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for general dental applications involving cutting teeth and removing dental materials. This is a mechanical function performed directly on the patient.
- Mechanism of Action: The device uses an air turbine and a check valve to prevent backflow of oral fluids. This is a physical mechanism, not a diagnostic test performed on a sample outside the body.
- Lack of Diagnostic Activity: There is no mention of analyzing biological samples (blood, urine, tissue, etc.) or providing diagnostic information about a patient's health condition.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This dental handpiece does not fit that description.
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. This device uses a USA-patented, long proven check valve, a Non-Retraction Valve, in the water line of the handpiece to prevent the oral fluids, which could be contaminated, from being drawn into the handpiece spray port(s) of the handpiece. The contaminants could reach beyond the handpiece, but this check valve, as being installed in the handpiece body, prevents them from reaching beyond the handpiece.
Product codes
EFB
Device Description
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Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
Not Found
Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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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)
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
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
5 1998 JUN
Mr. Hiroji Sekiguchi International Division II Manager Official Correspondent Nakanishi, Incorporated 240 Kamihinata, Kanuma-Shi, Tochigi-Ken 322 JAPAN
K980162 Re : Mach-Siqma Handpiece, Ultrapush Trade Name: Requlatory Class: I Product Code: EFB May 26, 1998 Dated: Received: May 29, 1998
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 leqally 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). 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in requlatory 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
1
Page 2 - Mr. Sekiguchi
through 542 of the Act for devices under the Electronic em-ough Sadiation 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 acbeing 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4692. Additionally, for questions on compriation and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 807.97) . Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers 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,
Timothy A. Ulatowski
Timotyy 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):
Air Turbine Handpiece, MACH-Sigma (Σ) Ultra-Push Device Name:
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.
This device uses a USA-patented, long proven check valve, a Non-Retraction Valve, in the water line of the handpiece to prevent the oral fluids, which could be contaminated, from being drawn into the handpiece spray port(s) of the handpiece. The contaminants could reach beyond the handpiece, but this check valve, as being installed in the handpiece body, prevents them from reaching beyond the handpiece.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Coucurrence of CDRH, Office of Device Evaluation (ODE)
Susan Ruaser
(Division Sign-Off) Division of Dental, Infection Control, and General Hospital 510(k) Number
Prescription Use (Per 21 CFR 801.109)
OR
Over-The-Counter Use
(Optional Formal 1-2-96)
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