(114 days)
Not Found
No
The description focuses on a mechanical handpiece and abrasive strips, with no mention of AI/ML or related concepts like image processing, data analysis, or algorithms.
No
The device is described as achieving interproximal reduction of teeth, being used with abrasive strips for stripping, polishing, or preparation of teeth for orthodontic appliances. These are mechanical functions, not therapeutic.
No
The device is used for interproximal reduction, stripping, polishing, or preparing teeth, which are all therapeutic or preparatory procedures, not diagnostic ones. It does not identify or characterize a disease or condition.
No
The device description explicitly states it includes a "handpiece" with an "air-driven low-speed motor" and "contra-angle integrated with the head," which are hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "achieving interproximal reduction of teeth." This is a mechanical procedure performed directly on the patient's teeth.
- Device Description: The device is a handpiece with a motor and contra-angle used with abrasive strips. This describes a tool for physical manipulation of teeth.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting diseases or conditions, or providing information for diagnosis.
IVD devices are specifically designed to examine specimens derived from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. This device does not fit that description.
N/A
Intended Use / Indications for Use
The Interproximal Reduction System is intended for use as a method of achieving interproximal reduction of teeth.
Product codes
EFB, EGS
Device Description
The Interproximal Reduction System handpiece includes an air-driven low-speed motor and a contra-angle integrated with the head. It is used with the abrasive strips for interproximal reduction/stripping, polishing, or preparation of tooth for placement of orthodontic appliances (aligners, brackets, retainers, etc.)
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
teeth
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)
Synea-LS Low Speed Handpiece (K993526), W&H Air Motor A25 (K944711)
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
510(k) SUMMARY
MAR 2 9 2006
DENTSPLY International Susquehanna Commerce Center West 221 West Philadelphia Street, Suite 60 York, PA 17405-0872
CONTACT: Helen Lewis
DATE PREPARED: December 2, 2005
TRADE OR PROPRIETARY NAME: Interproximal Reduction System
CLASSIFICATION NAME: Dental Handpiece and Accessories (21 CFR, Part 872.4200)
PREDICATE DEVICES: Synea-LS Low Speed Handpiece (K993526) W&H Air Motor A25 (K944711)
DEVICE DESCRIPTION:
The Interproximal Reduction System handpiece includes an air-driven low-speed motor and a contra-angle integrated with the head. It is used with the abrasive strips for interproximal reduction/stripping, polishing, or preparation of tooth for placement of orthodontic appliances (aligners, brackets, retainers, etc.)
INTENDED USE:
The Interproximal Reduction System is intended for use as a method of achieving interproximal reduction of teeth.
TECHNOLOGICAL CHARACTERISTICS:
All of the components found in the Interproximal Reduction System have been used in legally marketed devices and were found safe for dental use. We believe that the prior use of the components in legally marketed predicate devices and test results support the safety and effectiveness of the Interproximal Reduction System for the indicated uses.
1
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human figures, one behind the other, with their arms raised.
MAR 2 9 2006
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DENTSPLY International Ms. Helen Lewis Director of Corporate Compliance and Regulatory Affairs Susquehanna Commerce Center West 221 West Philadelphia Street, Suite 60 York, Pennsylvania 17404
Re: K053368
Trade/Device Name: Interproximal Reduction System Regulation Number: 872.4200 Regulation Name: Dental Handpiece and Accessories Regulatory Class: I Product Code: EFB, EGS Dated: March 13, 2006 Received: March 13, 2006
Dear Ms. Lewis:
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.
2
Page 2 -Ms. Lewis
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 vour 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,
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
3
INDICATIONS FOR USE
510(K) Number (if known): K053368
Interproximal Reduction System Device Name:
Indications for Use:
The Interproximal Reduction System is indicated as a method for achieving interproximal reduction of teeth.
Prescription Use X (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)
Suser Rummy
(Division Sign-Off)
Division of Anasthooloov, General Hospital, Infoclion Control, Demizi
510(k) Number: K053368
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