EMS KERMIT

K992504 · (Ems Sa) Electro Medical Systems · ELC · Jan 27, 2000 · Dental

Device Facts

• Record ID: K992504
• Device Name: EMS KERMIT
• Applicant: (Ems Sa) Electro Medical Systems
• Product Code: ELC · Dental
• Decision Date: Jan 27, 2000
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.4850
• Device Class: Class 2
• Attributes: Therapeutic

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

Device Story

EMS KERMIT is an ultrasonic scaler used by dental professionals in clinical settings. Device utilizes ultrasonic energy to drive specialized tips for mechanical removal of calculus and stains, periodontal pocket lavage, and various endodontic and restorative procedures. Operator controls frequency and intensity to perform scaling, root planing, and dental material manipulation. Output is mechanical vibration of the tip, which facilitates cleaning, irrigation, and material condensation. Benefits include efficient removal of dental deposits and precise preparation of root canals and restorative sites.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Ultrasonic scaler; utilizes ultrasonic energy for tip vibration. Designed for supra/subgingival scaling, periodontal lavage, endodontic, and restorative applications. Form factor is a dental unit with handpiece and interchangeable tips. No software or algorithm-based processing described.

Indications for Use

Indicated for dental patients requiring removal of supra/subgingival calculus and stains, periodontal pocket lavage, scaling, root planing, endodontic procedures (root canal preparation/cleaning/irrigation/retrograde preparation), and restorative procedures (releasing/cementing crowns, bridges, inlays, posts; amalgam condensation/burnishing; gutta percha condensation).

Regulatory Classification

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.

Predicate Devices

• EMS miniPiezon (K953026)
• Piezon Master 400 (K896749)
• Amdent® US30 (K920328)

Reference Devices

• KiS Microsurgical Instruments
• Sonicsys

Submission Summary (Full Text)

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JAN 27 2000

K992504

510(k) SUMMARY for EMS KERMIT®

- 1. SPONSOR
EMS SA Ch. de la Vuarpillière 31 CH - 1260 Nyon Switzerland

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

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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

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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 [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. 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 [phone] or [phone] 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

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K992504

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