(55 days)
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No
The summary does not mention AI, ML, or any related concepts like image processing, training sets, or performance metrics typically associated with AI/ML devices. The device description is for a standard airpolishing unit.
No
A therapeutic device is used to treat or cure a disease or condition. This device is used for cleaning (removing stains, plaque, and debris) or preparing teeth, which are functions that do not directly treat a disease or condition.
No
The device is described as an airpolishing unit used for removing stains, plaque, and debris, and for polishing prior to certain dental procedures. Its intended use focuses on treatment and preparation, not on identifying or diagnosing a condition.
No
The device description clearly states "JETSTREAM airpolishing unit," which is a physical piece of equipment, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to remove stains, plaque, and debris from teeth. This is a physical process performed directly on the patient's body (in vivo).
- Device Description: The device is an "airpolishing unit," which is consistent with a dental procedure performed in the mouth.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in a sample
- Providing information for diagnosis, monitoring, or screening based on sample analysis.
IVDs are used to examine specimens taken from the human body to provide information about a person's health. This device operates directly on the patient's teeth, which is not an in vitro process.
N/A
Intended Use / Indications for Use
The JETSTREAM airpolishing unit is intended to be used to remove stubborn stains, plaque and soft debris.
Device applications: Routine polishing especially hard to reach areas, polishing prior to enamel etching and bonding techniques and prior to bonding orthodontic bands and brackets
Product codes
KOJ
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
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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)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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.
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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.
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 872.6080 Airbrush.
(a)
Identification. An airbrush is an AC-powered device intended for use in conjunction with articulation paper. The device uses air-driven particles to roughen the surfaces of dental restorations. Uneven areas of the restorations are then identified by use of articulation paper.(b)
Classification. Class II. The special control for this device is International Electrotechnical Commission's IEC 60601-1-AM2 (1995-03), Amendment 2, “Medical Electrical Equipment—Part 1: General Requirements for Safety.”
0
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of an eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB 1 9 2002
Mr. Alan Edel Deldent Limited 19 Keren Kayemet Street Petach Tikvah, ISRAEL
Re: K014252
Trade/Device Name: JetStream Regulation Number: 872.6080 Regulation Name: AirPolishing Unit Regulatory Class: II Product Code: KOJ Dated: November 27, 2001 Received: December 26, 2001
Dear Mr. Edel
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 vour 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.
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.
1
Page 2 - Mr. Edel
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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613 . Additionally, for questions on the promotion 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 Part 807.97). Other general information on your responsibilities under the Act may be obtained 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/dsma/dsmamain.html
Sincerely yours,
Tim M. A. Hultquist
Timothy A. Ulatowski Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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LABELING
Page 1 of 1
川华S2 2
510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
Device Name: ____ JETSTREAM_
Indications for Use:
The JETSTREAM airpolishing unit is intended to be used to remove stubborn stains, plaque and soft debris.
Device applications: Routine polishing especially hard to reach areas, polishing prior to enamel etching and bonding techniques and prior to bonding orthodontic bands and brackets
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
Per 21 CFR801.109)
OR
Over-The-Counter Use (Optional Format 1-2-96)
Sugar Plum
"Thision Sign-Off) Ision of Dental, Infection Control, ି ଆଧାରୀ Hospital Devices Number_ KOJLIJAS