(65 days)
Not Found
No
The device description and performance studies focus on standard ultrasonic scaling technology and electrical safety standards, with no mention of AI or ML.
Yes
The device is described as an ultrasonic scaler intended for various dental procedures such as calculus and stain removal, scaling and root planning, and preparing/cleaning root canals, which are therapeutic interventions.
No
The device's intended uses all involve therapeutic or procedural actions (removing calculus, scaling, releasing crowns, etc.), not the diagnosis of a condition.
No
The device description clearly outlines hardware components such as a main chassis, power supply, controls, displays, ultrasonic generator, footswitch, handpiece, and instruments (tips). The performance studies also reference testing against hardware standards (IEC 60601-1, EN 55011, EN 60601-1-2).
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended uses listed are all related to direct dental procedures performed on a patient's teeth and gums (removing calculus, scaling, root planning, etc.). IVDs are used to examine specimens (like blood, urine, tissue) outside of the body to provide information about a person's health.
- Device Description: The device description details an ultrasonic scaler used for physical manipulation within the mouth. It does not mention any components or processes related to analyzing biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing specimens, reagents, or providing diagnostic information based on laboratory testing.
Therefore, the Cleanse S+ ultrasonic scaler is a medical device used for therapeutic and procedural purposes in dentistry, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
Intended for use during dental procedures to:
- Removing supra and subgingival calculus and stains
- Periodontal pocket lavage with simultaneous ultrasonic tip movement
- Scaling and root planning
- 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 (comma separated list FDA assigned to the subject device)
ELC
Device Description
The Cleanse S+ is an ultrasonic scaler consisting of a main chassis containing an external electric power supply, controls for water flow and ultrasonic intensity, displays, and ultrasonic generator. The device is connected directly to a water supply for irrigation during use. A footswitch used for on/off control is connected to the main chassis by a footswitch cord. A handpiece is connected to the main chassis by a handpiece cord. Instruments (stainless steel tips) designed for specific dental procedure are attached to the distal end of the handpiece.
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)
No clinical testing was conducted.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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.
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.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
SECTION 5
MAR 2 9 2006
510(K) SUMMARY
This summary of 510(K) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR §807.92.
The assigned 510(K) number is:_ KOGOI 71.
- Submitter's Identification: 1.
DMETEC CO.,LTD. #402-803 Techno-Park, 193 Yakdae-Dong, Wonmi-Ku, Bucheon, Korea Tel: +82-32-234-0011 Date Summary Prepared: January 20, 2006:
Name of the Device: 2.
Cleanse S+ Ultrasonic Scaler Proprietary Name: Classification Name: Scaler, Ultrasonic, product code ELC Classification: Class II, 21 CFR 872.4850
4. Predicate Device Information:
| America Green Dent Cleanse S | K033044 |
|---|---|
| EMS Mini Master | K953026 |
| EMS Piezon Master 600 | K022328 |
| EMS miniPiezon | K953026 |
ડ. Device Description:
The Cleanse S+ is an ultrasonic scaler consisting of a main chassis containing an external electric power supply, controls for water flow and ultrasonic intensity, displays, and ultrasonic generator. The device is connected directly to a water supply for irrigation during use. A footswitch used for on/off control is connected to the main chassis by a footswitch cord. A handpiece is connected to the main chassis by a handpiece cord. Instruments (stainless steel tips) designed for specific dental procedure are attached to the distal end of the handpiece.
1
Intended Use: 6.
- Removing supra and subgingival calculus and stains
- Periodontal pocket lavage with simultaneous ultrasonic tip movement
- Scaling and root planning
- 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
Comparison to Predicate Devices 7.
Cleanse S Ultrasonic Scaler - identical in component materials, including the handpiece, the scaler tips, and the sterilization box. Differs from the predicate in that the Cleanse S+ is a different unit design with different control functions (analog vs.digital), indicator lamps, and footswitch lock
EMS MiniMaster, (K050710), and EM.5 Piezon Master 600 (K022328): Same indications for use.
EMS miniPiezon legally marketed by under K953026: The Cleanse St Ultrasonic cleaner is similar in design, operation, and performance:
| DMETEC(Cleanse S+) | EMS(miniPiezon) | |
|---|---|---|
| UNIT | ||
| Supply voltage | 24V DC | 24V AC |
| Supply frequency | - | 50/60 Hz |
| Power consumption(max) | 22W max | 25W |
| Water supply pressure | 1 to 5 bar(15 to 72 psi) | 1 to 5 bar(15 to 72 psi) |
| OUTPUT CHARACTERISTICS | ||
| Maximum output power with load | 8W | 8W |
| Frequency range available | 24-32 kHz | 25-32 kHz |
| TRANSFORMER | ||
| Input | 110-240 VAC, 50-60Hz | 100/220 VAC/50-60Hz |
2
| HANDPIECE AND TIPS | Reusable -- Autoclavable
F ----------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Comments of A + 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 | Reusable-Autoclavable
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ |
|--------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Output | 24V DC/ 1.7A | 24V AC/ 1.25A |
Discussion of Non-Clinical Tests Performed for Determination of Substantial 8. Equivalence are as follows:
Testing was conducted in accordance with: IEC 60601-1:88+A1:91+A2:95 used in conjunction with EN 60601-1:90+A1/A12:93+A2/A13:96, and EN 55011:98+A1:99 and EN 60601-1-2:2001
Discussion of Clinical Tests Performed: 9.
No clinical testing was conducted.
Conclusions: 10.
The Cleanse S-- ultrasonic scaler is substantially similar to the predicates in intended use, operation, safety and function, and is effective for its' intended use.
3
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes coiled around it. The caduceus is surrounded by the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES. USA" in a circular arrangement. The logo is black and white.
Public Health Service
MAR 2 9 2006
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DMETEC Company Limited C/O Ms. Carolann Kotula Official Correspondent MDI Consultants, Incorporated 55 Northern Boulevard, Suite 200 Great Neck, New York 11021
Re: K060171
Trade/Device Name: Cleanse S+ Ultrasonic Scaler Regulation Number: 872.4850 Regulation Name: Ultrasonic Scaler Regulatory Class: II Product Code: ELC Dated: January 20, 2006 Received: January 24, 2006
Dear Ms. Kotula:
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.
4
Page 2 - Ms. Kotula
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 procced to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801). please contact the Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act 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/industry/support/index.html.
Sincercly vours.
Chiu Lin, Ph.D.
Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Section 4
Indications for Use
510(k) Number (if known): 长060171
Device Name: Cleanse S+ Ultrasonic Scaler
Indications For Use: Intended for use during dental procedures to:
-Remove supra and subgingival calculus and stains
- Remove ouple and Subge with simultaneous ultrasonic tip movement
- Scaling and root planning
- 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
Prescription Use __ × (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use __ (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE:-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Page of
Susan Pusone
infony, General Hostilla
Page Number K860171