(184 days)
No
The summary describes a standard ultrasonic scaler and does not mention any AI or ML capabilities, image processing, or performance metrics typically associated with AI/ML devices.
No
The device is an ultrasonic scaler used for dental procedures like removing calculus, scaling, and root planing, which are treatments rather than diagnostics.
No
Explanation: The device is an ultrasonic scaler used for various dental procedures like removing calculus, scaling, root planing, and preparing cavities and root canals. These are therapeutic and procedural functions, not diagnostic ones. The purpose is to perform treatments, not to identify or diagnose medical conditions.
No
The device is described as an "ultrasonic scaler," which is a hardware device that uses ultrasonic vibrations. The intended uses also describe physical actions like "removing supra and subgingival calculus deposits" and "scaling and root planing," which are performed by a physical instrument. There is no mention of software as the primary or sole component.
Based on the provided information, the EMS KERMIT® is not an IVD (In Vitro Diagnostic) device.
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information about a person's health. This testing is done outside of the body (in vitro).
- EMS KERMIT® Function: The EMS KERMIT® is an ultrasonic scaler used for dental procedures performed directly on the patient's teeth and surrounding structures (in vivo). Its intended uses involve removing deposits, scaling, preparing cavities, and other treatments within the mouth.
The description clearly indicates a device used for direct patient treatment, not for analyzing samples in a laboratory setting.
N/A
Intended Use / Indications for Use
The EMS KERMIT® is an ultrasonic scaler which is intended for the following:
- Removing supra and subgingival calculus deposits and stains from the teeth ●
- Periodontal pocket lavage with simultaneous ultrasonic tip movement
- Scaling and root planing .
- Releasing crowns, bridges, inlays and posts as well as condensing gutta percha ●
- Plugging for amalgam condensation ●
- Amalgam burnishing
- Preparing, cleaning, and irrigating root canals
- Preparing approximal cavities
- Cementing inlays and onlays
- Retrograde preparation of root canals
Product codes
ELC
Device Description
Not Found
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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)
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
JAN 27 2000
510(k) SUMMARY for EMS KERMIT®
-
- SPONSOR
EMS SA Ch. de la Vuarpillière 31 CH - 1260 Nyon Switzerland
- SPONSOR
Suzanne Fassio Contact Person: 022 994 47 00 Telephone:
Date Prepared: December 17, 1999
DEVICE NAME 2.
| Proprietary Name: | EMS KERMIT® |
|---|---|
| Common/Usual Name: | Ultrasonic Scaler |
| Classification Name: | Ultrasonic Scaler |
3. PREDICATE DEVICES
| EMS miniPiezon | K953026 |
|---|---|
| Piezon Master 400 | K896749 |
| KiS Microsurgical Instruments | |
| Sonicsys | |
| Amdent® US30 | K920328 |
4. INTENDED USE
- removing supra and subgingival calculus and stains .
- periodontal pocket lavage with simultaneous ultrasonic tip movement .
- scaling and root planing .
- releasing crowns, bridges, inlays and posts as wells as condensing gutta percha .
- plugging for amalgam condensation .
- . amalgam burnishing
- . preparing and rinsing root canals
1
Image /page/1/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human figures connected at the shoulders, forming a symbol that resembles a bird in flight.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN 27 2000
Cynthia J. M. Nolte, Ph.D., RAC Staff Consultant Medical Device Consultants, Incorporated 49 Plain Street North Attleboro, Massachusetts 02760
K992504 Re :
EMS KERMIT® Trade Name: Requlatory Class: II Product Code: ELC December 17, 1999 Dated: December 20, 1999 Received:
Dear Dr. Nolte:
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 able Blaced in the enousband, or 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 Regulations, Title 21, Parts 800 to 895. ਜੋ 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 regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any
2
Page 2 - Dr. Nolte
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 regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic 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.fdag.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
3
510(k) Number (if known):
Device Name: EMS KERMIT®
Indications for Use:
The EMS KERMIT® is an ultrasonic scaler which is intended for the following:
- Removing supra and subgingival calculus deposits and stains from the teeth ●
- Periodontal pocket lavage with simultaneous ultrasonic tip movement
- Scaling and root planing .
- Releasing crowns, bridges, inlays and posts as well as condensing gutta percha ●
- Plugging for amalgam condensation ●
- Amalgam burnishing
- Preparing, cleaning, and irrigating root canals
- Preparing approximal cavities
- Cementing inlays and onlays
- Retrograde preparation of root canals
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NECESSARY)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Susan Runner
(Division Sign-Off) Division of Dental, Infection Control, and General Hospital Devic 510(k) Number .
Prescription Use . (Per 21 CFR 801.109
OR
Over-The-Counter Use
EMS KERMIT® Additional Information - K992504 12/17/99