(70 days)
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Not Found
No
The summary describes a standard dental handpiece and contains no mention of AI, ML, image processing, or data sets typically associated with AI/ML devices.
No.
The device is used for removal of tissue and preparation of teeth, which are interventional procedures, not therapeutic ones.
No
The device description states its use is for the removal of carious tissue and preparation of teeth for restorations, which are treatment procedures, not diagnostic ones.
No
The device description explicitly states "Excel High Speed Hand Piece," which is a physical, hardware-based dental instrument. The intended use also describes a physical action (removal of tissue, preparation of teeth) performed by this hardware. 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:
- Intended Use: The intended use describes a physical procedure performed directly on the patient's teeth (removal of tissue, preparation for restorations, etc.). This is a therapeutic or procedural use, not a diagnostic one.
- Device Description: A "dental high speed handpiece" is a tool used for mechanical manipulation of tissue.
- Lack of Diagnostic Elements: There is no mention of analyzing samples (blood, tissue, etc.), performing tests, or providing diagnostic information about a patient's condition.
- Anatomical Site: The device is used on the teeth, which is a direct interaction with the patient's anatomy, not an analysis of a sample taken from the patient.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not fit that description.
N/A
Intended Use / Indications for Use
The dental high speed handpiece is a precision instrument used by a dental professional for the removal of carious tissue, the preparation of teeth for restorations, for crowns and bridges, and for cosmetic corrections. Note Federal Law restricts the use of this device to dental professionals.
Product codes
EFA
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
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Intended User / Care Setting
dental professional
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.)
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Predicate Device(s)
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Reference Device(s)
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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
Image /page/0/Picture/1 description: The image shows the logo for the Department of Health and Human Services, USA. The logo features a stylized eagle with three lines forming its body and wings. The eagle is encircled by the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA" in a circular arrangement.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 16 2006
Lloyd Taylor, DDS Owner/Operator OrthoSource, Incorporated 13343 Sherman Way North Hollywood, California 91605
Re: K061581
Trade/Device Name: Excel High Speed Hand Piece Regulation Number: 21 CFR 872.4200 Regulation Name: Dental Handpiece and Accessories Regulatory Class: I Product Code: EFA Dated: June 5, 2006 Received: June 7, 2006
Dear Dr. Taylor:
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 Amendinents, 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 approvisions 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.
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Page 2 – Dr. Taylor
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. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (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 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 regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Sylite Y. Micham O.M.D.
Chiu Lin, Ph.D. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
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Indications for Use
510(k) Number (if known): To Be Assigned
Device Name: Excel High Speed Hand Piece Indications For Use:
The dental high speed handpiece is a precision instrument used by a dental professional for the removal of carious tissue, the preparation of teeth for restorations, for crowns and bridges, and for cosmetic corrections. Note Federal Law restricts the use of this device to dental professionals.
Prescription Use × (Part 21 CFR 801 Subpart D)
Over-The-Counter Use AND /OR (21 CFR 801 Subpart C)
061581
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Susan Renner
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