COMPACT S, COMPACT S (LED)

K170104 · Dmetec.Co., Ltd. · ELC · Dec 27, 2017 · Dental

Device Facts

• Record ID: K170104
• Device Name: COMPACT S, COMPACT S (LED)
• Applicant: Dmetec.Co., Ltd.
• Product Code: ELC · Dental
• Decision Date: Dec 27, 2017
• 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 planning releasing crowns, bridges, inlays and posts as well as condensing gutta percha plugging for amalgam condensation amalgam burnishing preparing, cleanig, and irrigating root canals preparing approximal cavites cementing inlays and onlays retrograde preparation of root canals

Device Story

Compact S is an ultrasonic dental scaler module designed for integration into dental chairs. It converts electrical energy (24V) into ultrasonic vibrations (24-32 kHz) delivered via a handpiece to a stainless steel tip. The device facilitates various dental procedures, including scaling, root planing, and endodontic preparation. It is operated by dental professionals in a clinical setting. The device receives water supply and power from the host dental chair. The handpiece is available in standard or LED-illuminated versions. The output is controlled by the dental chair's existing interface. By providing precise ultrasonic vibration and irrigation, the device assists clinicians in removing calculus and preparing tooth structures, potentially improving procedural efficiency and patient outcomes.

Clinical Evidence

No clinical data. Substantial equivalence is supported by non-clinical performance testing, including electrical safety (IEC 60601-1), electromagnetic compatibility (IEC 60601-1-2), biocompatibility (ISO 10993-1), sterilization validation (ISO 17665-1/2), and software validation (IEC 62304).

Technological Characteristics

Ultrasonic scaler module; 24-32 kHz frequency; 24 VA max output. Materials: Titanium/SUS vibrator, PPSU handpiece body/caps, stainless steel (SUS420J2) tips. Powered by dental chair (24V). Connectivity: Integrated into dental chair. Sterilization: Compliant with ISO 17665-1/2. Software: IEC 62304 compliant.

Indications for Use

Indicated for dental patients requiring supra/subgingival calculus and stain removal, periodontal pocket lavage, scaling, root planing, crown/bridge/inlay/post release, gutta percha condensation, amalgam condensation/burnishing, root canal preparation/irrigation, approximal cavity preparation, and inlay/onlay cementation.

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

• CLEANSE S+ ULTRASONIC SCALER (K060171)

Submission Summary (Full Text)

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of the department's name encircling a symbol. The symbol is a stylized representation of three human profiles facing right, stacked on top of each other. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA".

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

December 27, 2017

DMETEC Co., Ltd. % Yang Dong CEO Onbix Corporation #821 Samil Plaza, 14, Dogok-ro 1-gil Gangnam-gu, Seoul 06253 KR

Re: K170104

Trade/Device Name: Compact S Regulation Number: 21 CFR 872.4850 Regulation Name: Ultrasonic Scaler Regulatory Class: Class II Product Code: ELC Dated: November 22, 2017 Received: November 30, 2017

Dear Yang Dong:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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.

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); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in

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the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely,

Mary S. Runner -S

For Tina Kiang, Ph.D. Acting Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number (if known) K170104

Device Name COMPACT S, COMPACT S(LED)

Indications for Use (Describe)

- 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, cleanig, and irrigating root canals
- preparing approximal cavites
- cementing inlays and onlays
- retrograde preparation of root canals

| Type of Use (Select one or both, as applicable) | |
|-------------------------------------------------|--|
|-------------------------------------------------|--|

X Prescription Use (Part 21 CFR 801 Subpart D)

| Over-The-Counter Use (21 CFR 801 Subpart C)

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# 510(k) SUMMARY

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of 21 CFR §807.92.

| Submitter Information: | DMETEC Co., Ltd. |
|------------------------|------------------------------------------------------|
| | 402-601,602,603 bucheon techno-park, |
| | 655 pyeongcheon-ro, wonmi-gu |
| | Bucheon-city gyeonggi-do, KOREA, REPUBLIC OF 420-734 |

| Contact Person: Ho Dong, Yang | |
|--------------------------------------------------|--|
| Onbix Corporation | |
| #821 Samil Plaza, 14, Dogok-ro 1-gil, Gangnam-gu | |
| Seoul, Korea (06253) | |
| Tel: *82-2-566-3360 / Fax: *82-2-6280-3360 | |
| Email: [e-mail] | |

Date Summary Prepared: Dec 27, 2017

#### Device Information:

Trade Name(s): Classification Name: Panel: Product Code & Requlation: COMPACT S. COMPACT S(LED) SCALER, ULTRASONIC

dental ELC / 872.4850

#### Predicate Device Information:

K060171 / CLEANSE S+ ULTRASONIC SCALER / DMETEC Co., Ltd.

# Device Description:

The purpose of the device is to remove plaque from the surface of the tooth through using ultrasonic vibration generated by the electricity(24 V ~) and water supply received in a dental chair and other dental devices.

The product is provided in the form of parts that can be installed and used inside a dental chair and other dental devices. The control of the water supply is made from the dental chair and other dental devices.

#### Indications for Use:

- 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, cleanig, and irrigating root canals
- preparing approximal cavites
- cementing inlays and onlays
- retrograde preparation of root canals

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# Summary of the technological characteristics compared to the predicate device

The proposed Compact S is virtually identical to the previously approved CLEANSE S + (ULTRASONIC SCALER, K060171).

Compact S is a model of drive module with the exterior case, power control keypad, and control device removed from the body of the previously approved product (CLEANSE S +), and can be installed to the dental chair.

The difference between the input powers of the two devices is that the previously approved product uses an adapter, and the proposed product is in a different form, powered by the dental chair.

The output current is also lowered from 40 VA to 24 VA due to structural changes due to the removal of the control keypad. However, the output of the handpiece is similar for both devices.

The difference between the two devices does not affect their safety or performance.

The device was conducted in compliance with the following Standard

- IEC 60601-1: 2005 + CORR. 1 (2006) + CORR. 2 (2007) : Medical electrical equipment Part 1: General requirements for basic safety and essential performance
- IEC 60601-1-2: 2007 (Third Edition) : Medical Electrical Equipment PART 1-2: General Requirements for Basic Safety and Essential Performance Collateral Standard: Electromagnetic Compatibility
- IEC 80601-2-60: 2012 (First Edition) : Medical electrical equipment: Part 2: Particular requirements for basic safety and essential performance of dental equipment

| | DMETEC<br>(COMPACT S) | DMETEC<br>(Cleanse S+) |
|--------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k)<br>reference | Proposed | K060171 |
| Indication for<br>use | - removing supra and subgingival<br>calculus and stains<br>- periodontal pocket lavage with<br>simultaneous ultrasonic tip movement<br>- scaling and root planning<br>- releasing crowns, bridges, inlays and<br>posts as well as condensing gutta<br>percha<br>- plugging for amalgam condensation<br>- amalgam burnishing<br>- preparing, cleanig, and irrigating root<br>canals<br>- preparing approximal cavites<br>- cementing inlays and onlays<br>- retrograde preparation of root canals | - removing supra and subgingival<br>calculus and stains<br>- periodontal pocket lavage with<br>simultaneous ultrasonic tip<br>movement<br>- scaling and root planning<br>- releasing crowns, bridges,<br>inlays and posts as well as<br>condensing gutta percha<br>- plugging for amalgam<br>condensation<br>- amalgam burnishing<br>- preparing, cleanig, and irrigating<br>root canals<br>- preparing approximal cavites<br>- cementing inlays and onlays<br>- retrograde preparation of root<br>canals |
| Supply<br>voltage | AC/DC 24 V, 50/60 Hz | Transformer input : 100-240 V<br>AC , 50/60 Hz<br>Transformer output : DC 24V |
| Water supply<br>pressure | 1 to 5 bar (15 to 72 psi) | 1 to 5 bar (15 to 72 psi) |
| Maximum<br>output power<br>with load | 24VA | 40VA |

Comparison table is as follows

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| Frequency range available | 24-32 kHz | | | | 24-32 kHz | | | |
|----------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------|--------------------------------|--|----------------------------------------------------------------------------------------------------|-------------------------------|------------------------|--|
| mode | Continuous | | | | Continuous | | | |
| Connection to second scaler unit | Not allowed | | | | Not allowed | | | |
| Main component | • Unit Body : 1ea<br>• Hand-piece : 1ea<br>(Normal type or LED type)<br>• Tip(Basic) : 3ea<br>• Tip(option) : 2ea | | | | • Unit Body : 1ea<br>• Hand-piece : 1ea(Normal type)<br>• Tips(Basic) : 3ea<br>• Tip(option) : 2ea | | | |
| | * Compact S is a model of drive module with the exterior case, power control keypad, and control device removed from the body of the previously approved product (CLEANSE S +), and can be installed to the dental chair.<br>*The COMPACT S and Cleanse S + use the same handpiece made from the same material. | | | | | | | |
| | COMPACT S&COMPACT S LED | | | | Cleanse S+ | | | |
| | 1 | Vibrator | Titanium+SU S | | 1 | Vibrator | Titanium+SU S | |
| | 2 | Outsider cap | PPSU/25mm<br>80-170 | | 2 | Outsider cap | PPSU/25mm<br>80-170 | |
| | | Outsider cap<br>(LED Type) | $17.6Φ*23.7m$<br>m | | | | | |
| | 3 | H.P BODY | PPSU/68mm<br>140-170 | | 3 | H.P BODY | PPSU/68mm<br>140-170 | |
| | | H.P BODY<br>(LED Type) | PPSU/70mm<br>$18.5Φ$ - $17.5Φ$ | | | | | |
| | 4 | HP Socket<br>(Upper) | PPSU/12.5m<br>m 150 | | 4 | HP Socket<br>(Upper) | PPSU/12.5m<br>m 150 | |
| | 5 | HP socket<br>(down) | PPSU/15mm<br>11.50 | | 5 | HP socket<br>(down) | PPSU/15mm<br>11.50 | |
| | 6 | Handpiece C | PPSU/19mm<br>8 | | 6 | Handpiece C | PPSU/19mm<br>8 | |
| | 7 | O-ring 3 $Φ$<br>1.8T | Rubber/006 | | 7 | O-ring 3 $Φ$<br>1.8T | Rubber/006 | |
| | 8 | Vibrator O-ring down | 10 $Ø$ *1mm | | 8 | Vibrator O-ring down | 10 $Ø$ *1mm | |
| | 9 | Handpiece socket O-ring Upper | Rubber/S11 | | 9 | Handpiece socket O-ring Upper | Rubber/S11 | |
| | 10 | Water pin O-ring1 $Φ$ 1T | Rubber/P2 | | 10 | Water pin O-ring1 $Φ$ 1T | Rubber/P2 | |
| | 11 | Terminal pin female | 4*21.8mm | | 11 | Terminal pin female | 4*21.8mm | |
| | 12 | Water pin | inside1 $Ø$<br>4*21mm | | 12 | Water pin | inside1 $Ø$ 4*2<br>1mm | |
| | 13 | LED Module<br>(LED Type) | $Ø$ 15.2*18.5m<br>m | | - | | | |
| | *The difference between the two types of handpieces is the presence or absence of LEDs illuminating the mouth. | | | | | | | |

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| Tip material<br>(contact with<br>patient) | Stainless steel(SUS420J2) ※ The COMPACT S and Cleanse S + use the same shaped tip for the same<br>material. | Stainless steel(SUS420J2) |
|-------------------------------------------|--------------------------------------------------------------------------------------------------------------------------|---------------------------|
|-------------------------------------------|--------------------------------------------------------------------------------------------------------------------------|---------------------------|

# Summary of Non-Clinical performance testing as basis for substantial equivalence

Non-clinical performance testing demonstrates that all design inputs for the Compact S is satisfied by the design outputs. Testing of the device, when integrated with a dental chair and handpiece was performed. Results of the integration testing showed that the device met electrical safety (IEC 60601-1) and electromagnetic compatibility (IEC 60601-1-2) requirements. Additional integration testing included basic and essential performance as well as validation of the software in its actual use. Results from the functional and performance testing showed that the device met the predetermined acceptance criteria. The similarities in intended use, operational characteristics, and functional technological characteristics between the proposed Compact S and the parent Clenase S+ lead to a conclusion of substantial equivalence between the proposed and predicate device.

The results of this testing confirm that the Compact S is as safe and effective as the predicate device for the intended use.

#### Summary of clinical test as basis for substantial equivalence.

No clinical testing was conducted to support this submission.

#### Summary of non-clinical performance testing

all performance bench tests, sterilization and cleaning validations, biocompatibility, electrical and EMC and software.

The device was conducted in compliance with the following Standard

- IEC 60601-1: 2005 + CORR. 1 (2006) + CORR. 2 (2007) : Medical electrical equipment Part 1: General requirements for basic safety and essential performance
- IEC 60601-1-2: 2007 (Third Edition) : Medical Electrical Equipment PART 1-2: General Requirements for Basic Safety and Essential Performance Collateral Standard: Electromagnetic Compatibility
- IEC 80601-2-60: 2012 (First Edition) : Medical electrical equipment: Part 2: Particular requirements for basic safety and essential performance of dental equipment
- · ISO 17665-1/2 Sterilization of health care products
- · IEC 62304: 2006 : Medical device software Software life-cycle processes
- ISO 10993-1: 2009 : Biological evaluation of medical devices biocompatibility

#### Conclusion drawn from non-clinical and clinical tests

The similarities in intended use, operational characteristics, and functional technological characteristics between the proposed COMPACT S and the Cleanse S+ lead to a conclusion of substantial equivalence between the proposed and predicate device