(226 days)
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No
The description focuses on a mechanical dental handpiece and does not mention any AI or ML components or functionalities.
No.
The device is used for mechanical preparation and finishing, not for treating a disease or condition itself.
No
The device, a dental slow-speed handpiece, is described as an instrument for procedures like removing carious tissue, preparing teeth for restorations, and polishing. Its function is interventional and restorative, not diagnostic.
No
The device description clearly identifies it as a "Contra Angle Hand Piece," which is a physical, mechanical dental instrument. The intended use also describes physical actions performed by the handpiece. There is no mention of software as the primary or sole component.
No, 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, or tissue) to provide information about a person's health. This information is used for diagnosis, monitoring, or screening.
- Device Function: The description clearly states the dental slow speed handpiece is a precision instrument used directly on teeth for procedures like removing tissue, preparing teeth, and finishing restorations. It does not involve analyzing specimens taken from the body.
- Intended Use: The intended use is for dental procedures performed in the mouth, not for laboratory analysis of biological samples.
Therefore, based on the provided information, the dental slow speed handpiece is a dental instrument used for direct treatment, not an IVD.
N/A
Intended Use / Indications for Use
The dental slow speed handpiece is a precision instrument used by a dental professional at slow speed (100 to 20,000 rpm) for the removal of carious tissue, the preparation of teeth for restorations, for crowns and bridges, for cosmetic correction, and for the trimming, finishing, and polishing of all types of dental restorations and prostheses. Note: Federal Law restricts the use of this device to dental professionals.
Product codes
EGS
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)
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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
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§ 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.
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Image /page/0/Picture/11 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract image of an eagle.
ood and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Dr. Lloyd R. Taylor President OrthoSource, Incorporated 13343 Sherman Way North Hollywood, California 91605
FEB 1 4 2007
Re: K061897
Trade/Device Name: Excel Contra Angle Hand Piece Regulation Number: 872,4200 Regulation Name: Dental Handpiece and Accessories Regulatory Class: I Product Code: EGS Dated: January 11, 2007 Received: January 17, 2007
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 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.
1
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 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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours.
Snytte y. Michael Dms.
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
Enclosure
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Indications for Use
510(k) Number (if known): To Be Assigned
Device Name: Excel Contra Angle Hand Piece Indications For Use:
The dental slow speed handpiece is a precision instrument used by a dental professional at slow speed (100 to 20,000 rpm) for the removal of carious tissue, the preparation of teeth for restorations, for crowns and bridges, for cosmetic correction, and for the trimming, finishing, and polishing of all types of dental restorations and prostheses. Note: Federal Law restricts the use of this device to dental professionals.
× Prescription Use (Part 21 CFR 801 Subpart D)
AND /OR Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Susan Runver
(Division Sign-Off) (Division Sign-Olf)
Division of Anasthesiology, General Hospital, Infection Control, Cental Devices
510(k) Number: K061897