(2 days)
Not Found
No
The summary describes a mechanical dental handpiece for calculus and plaque removal and does not mention any AI/ML components or functions.
Yes
The device is designed for the removal of calculus, plaque, and stains from teeth, which are therapeutic actions to maintain oral health.
No
The device description states its intended use is for the removal of calculus, plaque, and stains from teeth, which are therapeutic and prophylactic actions, not diagnostic ones. It performs a physical dental procedure (cleaning/scaling) rather than identifying or assessing a condition.
No
The device description clearly states it is a "Sterilizable Handpiece," which is a physical, hardware component used in dental procedures. There is no mention of software as the primary or sole component of the device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the physical removal of calculus, plaque, and stains from teeth. This is a mechanical procedure performed directly on the patient's teeth.
- Device Description: The device is a dental handpiece used with dental units. It is a tool for performing a dental procedure.
- Lack of In Vitro Activity: IVDs are designed to examine specimens outside of the body (in vitro) to provide information about a patient's health or condition. This device does not involve the analysis of any biological samples or specimens.
The device is a dental instrument used for a therapeutic and prophylactic procedure, not for diagnostic testing of biological samples.
N/A
Intended Use / Indications for Use
The Jet-Mate™ Sterilizable Handpiece is designed for general prophylaxis treatments to remove calculus, plaque and stains from teeth.
Designed for use in general prophylaxis and periodontal treatments and other areas of operative dentistry for the supragingival and subgingival removal of calculus, plaque and stains from teeth.
Product codes
76 ELC
Device Description
The Jet-Mate™ Sterilizable Handpiece is a detachable dental handpiece. It is designed to be detached from the cable assembly for the purpose of autoclave sterilization. This modified handpiece is used with the Cavitron® dental units.
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)
Steri-Mate™ Handpiece K941392
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 872.4850 Ultrasonic scaler.
(a)
Identification. An ultrasonic scaler is a device intended for use during dental cleaning and periodontal (gum) therapy to remove calculus deposits from teeth by application of an ultrasonic vibrating scaler tip to the teeth.(b)
Classification. Class II.
0
6 2002 NOV
DENTSPLY
NAME & ADDRESS:
DENTSPLY International
570 West College Avenue ) Box 877 rk, PA 17405-0872 71 845-7511 ax (717) 849-4762
P. J. Lehn Telefax (717) 849-4343
P. Jeffery Lehn CONTACT:
October 30, 2002 DATE PREPARED:
JET-MATE™ STERILIZABLE HANDPIECE TRADE OR PROPRIETARY NAME:
Accessory to dental units (872.4850 and 872.6080) CLASSIFICATION NAME:
PREDICATE DEVICES: Steri-Mate™ Handpiece K941392
DESCRIPTION OF DEVICE: The Jet-Mate™ Sterilizable Handpiece is a detachable dental handpiece. It is designed to be detached from the cable assembly for the purpose of autoclave sterilization. This modified handpiece is used with the Cavitron® dental units.
INTENDED USE: The Jet-Mate™ Sterilizable Handpiece is designed for general prophylaxis treatments to remove calculus, plaque and stains from teeth
TECHNOLOGICAL CHARACTERISTICS: The Jet-Mate™ Sterilizable Handpiece has the same principles of operation and is very similar in design characteristics to the marketed device. Therefore, we believe that the Jet-Mate™ Sterilizable Handpiece is substantially equivalent to the Steri-Mate® Handpiece (K941392).
Because of the nearly equivalent material composition of JET-MATE™ STERILIZABLE HANDPIECE to the predicate device, no additional toxicity testing was necessary.
We believe that the prior use of the components of JET-MATE™ STERILIZABLE HANDPIECE in legally marketed devices and the data provided support the safety and effectiveness of JET-MATE™ STERILIZABLE HANDPIECE for the intended uses.
1
DEPARTMENT OF HEALTH & HUMAN SERVICES
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NOV
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. P. Jeffery Lehn Director, Compliance and Regulatory Affairs DENTSPLY International 570 West College Avenue P.O. Box 872 York, Pennsylvania 17405-0872
Re: K023697
Trade/Device Name: Jet-Mate™ Sterilizable Handpiece Regulation Number: 21 CFR 872.4850 Regulation Name: Ultrasonic Scaler Regulatory Class: II Product Code: 76 ELC Dated: October 30, 2002 Received: November 4, 2002
Dear Mr. Lehn:
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 - Mr. Lehn
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 vou 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,
Timothy Ulatowski
Timothy latowski Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
3
INDICATIONS FOR USE STATEMENT
(As Required by 21 CFR 807.87(e)
510(K) Number (if known):
Device Name: Jet-Mate™ Sterilizable Handpiece
Designed for use in general prophylaxis and periodontal treatments and other areas of operative dentistry for the supragingival and subgingival removal of calculus, plaque and stains from teeth.
This is the same intended use as previously cleared for K941392, Steri-Mate™ Handpiece.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
OR
Over-The-Counter Use
(Per 21 CFR 801.109)
(Optional Format 1-2-96)
Suxir Rumney
(Division Sign-Off) Division of Anesthesiology, General Hospital, Infection Control, Dental Devices
510(k) Number ...