(58 days)
Not Found
No
The document explicitly states "Mentions AI, DNN, or ML: Not Found" and the device description focuses on mechanical and electrical components without any mention of AI/ML functionalities.
Yes
The device is used for the removal of calculus deposits and stains from teeth, periodontal pocket lavage, scaling, and root planing, which are therapeutic procedures to treat and maintain oral health.
No
Explanation: The device is described as an ultrasonic scaler intended for the removal of calculus deposits and stains, periodontal pocket lavage, and scaling and root planing, which are therapeutic procedures, not diagnostic ones.
No
The device description explicitly lists hardware components such as a control unit housing, ultrasonic generator, dental handpiece, scaler instrument, and torque wrench.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health.
- Device Function: The EMS Surface Mount Scaler is used directly on the patient's teeth to remove calculus and stains. It is a therapeutic and cleaning device, not a diagnostic one that analyzes samples.
- Intended Use: The intended use clearly describes a procedure performed in vivo (on a living organism), not in vitro (in a lab setting).
The device description and intended use confirm its function as a dental tool for cleaning and scaling, which falls outside the scope of In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
The EMS Surface Mount Scaler is an ultrasonic scaler and is intended for the removal of supra and subgingival calculus deposits and stains from the teeth; periodontal pocket lavage with simultaneous ultrasonic tip movement; and scaling and root planing.
The EMS Surface Mount Scaler is indicated for use in:
- Removal of supra and subgingival calculus deposits and stains from the teeth .
- Periodontal pocket lavage with simultaneous ultrasonic tip movement .
- Scaling and root planing .
Product codes
ELC
Device Description
The EMS Surface Mount Scaler consists of a control unit housing containing the ultrasonic generator, a dental handpiece, scaler instrument, and torque wrench. The Scaler is designed to operate in conjunction with the office dental unit. The control unit housing is mounted under the control head of the dental unit and is connected to the water supply, hanger air supply, pneumatic foot switch, and electrical supply of the dental unit. The Scaler ultrasonic power and water flow are simultaneously activated by pressing the dental unit foot switch. Power output and water flow can be adjusted using the knobs on the front of the Scaler. The Scaler handpiece is designed to be placed in the dental unit's handpiece hanger when not in use.
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
dental unit
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)
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
K99,1874
510(k) Summary for EMS Surface Mount Scaler
1. SPONSOR
EMS SA Ch. de la Vuarpilliere 31 CH - 1260 Nyon Switzerland
Suzanne Fassio Contact Person: 022 994 47 00 Telephone:
June 1, 1999 Date Prepared:
2. DEVICE NAME
Proprietary Name: Common/Usual Name: Classification Name:
EMS Surface Mount Scaler Ultrasonic Scaler Ultrasonic Scaler
PREDICATE DEVICES 3.
EMS miniPiezon Ultrasonic Scaler K953026
4. INTENDED USE
The EMS Surface Mount Scaler is an ultrasonic scaler and is intended for the removal of supra and subgingival calculus deposits and stains from the teeth; periodontal pocket lavage with simultaneous ultrasonic tip movement; and scaling and root planing.
5. DEVICE DESCRIPTION
The EMS Surface Mount Scaler consists of a control unit housing containing the ultrasonic generator, a dental handpiece, scaler instrument, and torque wrench. The Scaler is designed to operate in conjunction with the office dental unit. The control unit housing is mounted under the control head of the dental unit and is connected to the
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water supply, hanger air supply, pneumatic foot switch, and electrical supply of the dental unit. The Scaler ultrasonic power and water flow are simultaneously activated by pressing the dental unit foot switch. Power output and water flow can be adjusted using the knobs on the front of the Scaler. The Scaler handpiece is designed to be placed in the dental unit's handpiece hanger when not in use.
TECHNOLOGICAL CHARACTERISTICS AND SUBSTANTIAL EQUIVALENCE Q.
The Surface Mount Scaler is substantially equivalent to the EMS miniPiezon ultrasonic scaler. Both devices are intended to be used for the removal of calculus deposits and stains from the teeth. The devices use the same ultrasonic generator and handpiece. The main difference between the devices is that the miniPiezon is a stand-alone ultrasonic scaler while the Surface Mount Scaler works in conjunction with the office dental unit. Minor differences in the user interface, and in the power, air, and water supplies, do not raise new questions of safety and effectiveness, leading to a conclusion of substantial equivalence.
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Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three lines representing its head, body, and tail. The eagle is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL 30 1999
(EMS SA) Electro Medical Systems c/o Sheila Hemeon-Heyer, Esq., RAC Senior Staff Consultant Medical Device Consultants, Incorporated 49 Plain Street North Attleboro, Massachusetts 02760
K991874 Re : EMS Surface Mount Scaler Trade Name: Requlatory Class: II Product Code: ELC Dated: June 1, 1999 Received: June 2, 1999
Dear Sheila Hemeon-Heyer, Esq., RAC:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act 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 (Premarket Approval), it may be subject to such additional controls. Existing major requlations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) requlation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation may result in requlatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register.
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Page 2 - Sheila Hemeon-Heyer, Esq., RAC
this response to your premarket notification Please note: submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
This letter will allow you to begin marketing your device as described in your 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 requlation (21 CFR Part 801 and additionally 809.10 for in vitro diaqnostic devices), please contact the Office of Compliance at (301) 594-4692. 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" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely Yours,
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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510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
Device Name: EMS Surface Mount Scaler
Indications For Use:
The EMS Surface Mount Scaler is indicated for use in:
- Removal of supra and subgingival calculus deposits and stains from the teeth .
- Periodontal pocket lavage with simultaneous ultrasonic tip movement .
- Scaling and root planing .
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NECESSARY)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| (Division Sign-Off) | Pamela Scott for Susan Runner |
|---|---|
| Division of Dental, Infection Control, | |
| and General Hospital Devices | K991874 |
| 510(k) Number |
| Prescription Use ✓
| (Per 21 CFR 801.109) | OR | Over-The-Counter Use ______ |
|---|---|---|
| -------------------------------------------------------------------------------------------- | ---- | ----------------------------- |
(Optional Format 1-2-96)
| EMS SA 510(k) | 6/01/99 |
|---|---|
| --------------- | --------- |
EMS Surface Mount Scaler