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K Number
K191079
Device Name
Piezon Built-in Kit, Piezon Built-in Kit LED
Manufacturer
E.M.S Electro Medical Systems S.A
Date Cleared
2019-08-16

(115 days)

Product Code
ELC
Regulation Number
872.4850
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Scaling: - Removal of supragingival and subgingival calculus - Removal of stains
Device Description
The proposed devices, PIEZON BUILT-IN KIT and the PIEZON BUILT-IN KIT LED, represent a change in presentation from the stand alone PIEZON 150 (predicate) to a device which is built in to the dental chair (OSSTEM K3 (K152830) ). The proposed device and the predicate device are both manufactured using the same internal componentry, the only difference is that instead of housing the device for stand alone use, the componentry is installed into a dental chair. The difference between PIEZON® BUILT-IN KIT LED and PIEZON® BUILT-IN KIT is that the handpiece of the first features integrated light (LED) while the second does not. All other aspects are identical. Each system consists of the wireless module and handpiece cord and is provided with a wire harness for installation as well as the appropriate accessories. Additionally, spare parts are available. As with other ultrasonic scalers, the ultrasonic generator component of the PIEZON BUILT-IN KIT and PIEZON BUILT-IN KIT LED (Piezon® Module EJ-110, installed in a dental chair) generates piezo-electric vibrations (ultrasonics) for water or dry work instruments. The PIEZON BUILT-IN KIT and PIEZON BUILT-IN KIT LED are supplied with the Piezon Handpiece EN-061/OS and Piezon Handpiece LED EN-060/OS, respectively. Instruments mounted in the Piezon Handpiece or Piezon Handpiece LED vibrates with a controlled oscillatory movement when activated. Instruments A is supplied as part of all kits. Instruments P and PS are additionally included in the kits with OS1 suffix. The appropriate instrument for the particular application is screwed onto the handpiece prior to beginning the procedure. The treatment is carried out by placing the instrument tip onto the tooth surface according to the Operating Instruction for the instrument selected.
More Information

K132443

Not Found

No
The description focuses on the device's mechanical and electrical components for ultrasonic scaling, with no mention of AI or ML capabilities.

Yes
The device is used for the removal of calculus and stains from teeth, which are therapeutic actions aimed at improving oral health.

No

The device is an ultrasonic scaler intended for removal of supragingival and subgingival calculus and stains, which are therapeutic rather than diagnostic actions.

No

The device description clearly outlines physical components such as handpieces, wireless modules, handpiece cords, wire harnesses, and internal componentry that generates ultrasonic vibrations. It is integrated into a dental chair, which is also a physical device. This is not a software-only device.

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

  • Intended Use: The intended use is "Removal of supragingival and subgingival calculus" and "Removal of stains." These are procedures performed directly on the patient's teeth and soft tissues in the mouth.
  • Device Description: The device is an ultrasonic scaler that generates vibrations to remove calculus and stains. This is a physical intervention, not a diagnostic test performed on a sample taken from the body.
  • Lack of IVD Characteristics: There is no mention of analyzing samples (blood, urine, tissue, etc.), detecting specific analytes, or providing diagnostic information about a patient's health condition.

IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not fit that description.

N/A

Intended Use / Indications for Use

Scaling:

  • Removal of supragingival and subgingival calculus
  • Removal of stains

Product codes (comma separated list FDA assigned to the subject device)

ELC

Device Description

The proposed devices, PIEZON BUILT-IN KIT and the PIEZON BUILT-IN KIT LED, represent a change in presentation from the stand alone PIEZON 150 (predicate) to a device which is built in to the dental chair (OSSTEM K3 (K152830)). The proposed device and the predicate device are both manufactured using the same internal componentry, the only difference is that instead of housing the device for stand alone use, the componentry is installed into a dental chair.

The difference between PIEZON BUILT-IN KIT LED and PIEZON BUILT-IN KIT is that the handpiece of the first features integrated light (LED) while the second does not. All other aspects are identical. Each system consists of the wireless module and handpiece cord and is provided with a wire harness for installation as well as the appropriate accessories. Additionally, spare parts are available.

As with other ultrasonic scalers, the ultrasonic generator component of the PIEZON BUILT-IN KIT and PIEZON BUILT-IN KIT LED (Piezon Module EJ-110, installed in a dental chair) generates piezo-electric vibrations (ultrasonics) for water or dry work instruments. The PIEZON BUILT-IN KIT and PIEZON BUILT-IN KIT LED are supplied with the Piezon Handpiece EN-061/OS and Piezon Handpiece LED EN-060/OS, respectively. Instruments mounted in the Piezon Handpiece or Piezon Handpiece LED vibrates with a controlled oscillatory movement when activated.

Instruments A is supplied as part of all kits. Instruments P and PS are additionally included in the kits with OS1 suffix. The appropriate instrument for the particular application is screwed onto the handpiece prior to beginning the procedure. The treatment is carried out by placing the instrument tip onto the tooth surface according to the Operating Instruction for the instrument selected.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Teeth and soft tissues in the mouth.

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)

A Risk Assessment was performed to review associated risks for this configurable Piezon kit assembly which consists of parts for ultrasonic treatment that are incorporated into a dental unit (chair). This initial risk assessment includes clinical and device specific risks for the PIEZON BUILT-IN KIT alone. An additional risk analysis was performed to address the risk of the product as a subsystem of a treatment unit (dental chair) to include any additional or changed risks that arise from the inclusion of the kit as a component of a dental chair. The combination of these two Risk Analyses were prepared to determine the necessary safety measures in design and manufacturing. The risks related to all applicable hazards which were identified for the PIEZON BIK have been reduced to the acceptable level by mitigation. Therefore, all residual risks postmitigation have been deemed acceptable for this design.

There are no changes to any functional specifications or components included in this submission. The proposed device and the predicate device are both manufactured using the same internal componentry, and the same attached accessories; the only difference is that instead of housing the device for stand alone use, the componentry is installed into a dental chair.

Biocompatibility: Biocompatibility assessment was performed according to ISO 10993-1 and no testing was necessary since all patient contacting components are identical to the cleared predicate – Piezon 150 (K132443).

Electrical Safety and Electromagnetic Compatibility Testing: Electrical Safety and Electromagnetic Compatibility are equivalent to the predicate device based on IEC 60601-1 & IEC 60601-1-2. All tests passed and conformance is confirmed.

Integration Testing: To verify that the removal of the housing unit and incorporation into a dental chair does not impact the performance of the BIK, functional testing was completed on the integrated product to confirm product functionality. Integration testing includes both verification of device installation into the chair as per installation specifications and confirmation of product functionality.

All tests were successfully performed and all acceptance criteria were met, thus confirming that the PIEZON BUILT-IN KIT and the PIEZON BUILT-IN KIT LED satisfactorily meet requirements. No new questions of safety and effectiveness were identified during review of Risk Management documentation or during execution of testing.

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.

K132443

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.

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Image /page/0/Picture/0 description: The image shows the logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the text "FDA U.S. FOOD & DRUG ADMINISTRATION" in blue.

November 1, 2019

E.M.S Electro Medical Systems S.A % Christina Henza Regulatory Ultra LifeScience Solutions Inc. 872 S. Milwaukee Ave #286 Libertyville, Illinois 60048

Re: K191079

Trade/Device Name: Piezon Built-in Kit, Piezon Built-in Kit LED Regulation Number: 21 CFR 872.4850 Regulation Name: Ultrasonic scaler Regulatory Class: Class II Product Code: ELC Dated: May 20, 2019 Received: May 20, 2019

Dear Christina Henza:

This letter corrects our substantially equivalent letter of August 16, 2019.

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.

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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 of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely.

Digitally signed by Michael E. Michael E. Adiodha -S Date: 2019.11.01 07:05:39 Adiodha -S -04'00'

for Srinivas Nandkumar, Ph.D. Acting Director DHT1B: Division of Dental Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K191079

Device Name PIEZON BUILT-IN KIT

Indications for Use (Describe) Scaling:

  • Removal of supragingival and subgingival calculus

  • Removal of stains
    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 for PIEZON BUILT-IN KIT - K191079

Date: August 8, 2019 l.

ll. SUBMITTTER/ 510(K) HOLDER

E.M.S. Electro Medical Systems S.A. Ch. de la Vuarpillière 31 CH - 1260 Nyon Switzerland

Primary Contact:

Suzanne FASSIO-HARDY, Regulatory Affairs Manager - Dental Direct: +41 22 99 44 771 Email: sfassiohardy@ems-ch.com

Submission Contact:

Christina Henza Regulatory Affairs Consultant 872 S. Milwaukee Ave #286 Libertyville, IL 60048 +1 262 220 3463 chenza@ultralifescience.com

  • III. DEVICE NAME
    Proprietary Name: PIEZON BUILT-IN KIT Common/Usual Name: Ultrasonic scaler Classification Name: Ultrasonic scaler (872.4850) Device Class: II Product Code: ELC

IV. PREDICATE DEVICES

E.M.S. Electro Medical Systems S.A., Piezon 150 (K132443 cleared on 11/22/2013). This predicate has not been subject to a design-related recall. No reference devices were used in this submission.

V. DEVICE DESCRIPTION

The proposed devices, PIEZON BUILT-IN KIT and the PIEZON BUILT-IN KIT LED, represent a change in presentation from the stand alone PIEZON 150 (predicate) to a device which

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is built in to the dental chair (OSSTEM K3 (K152830) ). The proposed device and the predicate device are both manufactured using the same internal componentry, the only difference is that instead of housing the device for stand alone use, the componentry is installed into a dental chair.

The difference between PIEZON® BUILT-IN KIT LED and PIEZON® BUILT-IN KIT is that the handpiece of the first features integrated light (LED) while the second does not. All other aspects are identical. Each system consists of the wireless module and handpiece cord and is provided with a wire harness for installation as well as the appropriate accessories. Additionally, spare parts are available.

As with other ultrasonic scalers, the ultrasonic generator component of the PIEZON BUILT-IN KIT and PIEZON BUILT-IN KIT LED (Piezon® Module EJ-110, installed in a dental chair) generates piezo-electric vibrations (ultrasonics) for water or dry work instruments. The PIEZON BUILT-IN KIT and PIEZON BUILT-IN KIT LED are supplied with the Piezon Handpiece EN-061/OS and Piezon Handpiece LED EN-060/OS, respectively. Instruments mounted in the Piezon Handpiece or Piezon Handpiece LED vibrates with a controlled oscillatory movement when activated.

Instruments A is supplied as part of all kits. Instruments P and PS are additionally included in the kits with OS1 suffix. The appropriate instrument for the particular application is screwed onto the handpiece prior to beginning the procedure. The treatment is carried out by placing the instrument tip onto the tooth surface according to the Operating Instruction for the instrument selected.

  • VI. INDICATIONS FOR USE
    Scaling:

  • Removal of supragingival and subgingival calculus

  • Removal of stains

  • VII. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS OF PROPOSED COMPARED TO THE PREDICATE DEVICE
    The proposed device and the predicate device have equivalent technological characteristics. The proposed device and the predicate device are both manufactured using the same internal componentry. The devices meet the same performance specifications and the change in presentation from a stand alone device to a built in device has been validated.

The safety and effectiveness questions regarding the change in presentation from a stand alone device to a built in device are whether the device maintains electrical safety / compatibility characteristics and whether the use is adequately described within the instructions. These questions apply to both the proposed device and the predicate; the proposed device does not raise different questions of safety and efficacy.

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Therefore, the proposed devices, PIEZON BUILT-IN KIT & PIEZON BUILT-IN KITLED, meets substantial equivalence requirements with regards to the legally marketed predicate PIEZON 150 (K132443 cleared on 11/22/2013).

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Substantial Equivalence Table
Item for ComparisonProposed Device
(PIEZON BUILT-IN KIT & PIEZON BUILT-IN
KIT LED)Predicate Device
(PIEZON 150)Variation
ulatory InformatNamePIEZON BUILT-IN KIT & PIEZON BUILT-IN
KIT LEDPiezon 150N/A
510(k)#K191079K132443N/A
PredicatesK132443K953026 & K093000N/A
Product CodeELCELCSame.
Class22Same.
Combination
ProductNoNoSame.
Regulation
Number872.4850872.4850Same.
Regulation
Generic NameUltrasonic scalerUltrasonic scalerSame.
tended usRegulation
Intended Use"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""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"Same.
IndicationsScaling:
  • Removal of supragingival and subgingival c
    alculus
  • Removal of stains | The PIEZON 150 is a device for delivering
    ultrasonic movement and water to a
    stainless steel tip which is used by a
    dentist or dental Hygienist. The
    Indications for use are:
  • Periodontal pocket lavage with
    simultaneous ultrasonic tip movement
  • scaling and root planning
  • Removal of supra and subgingival
    calculus and stains from teeth. | Equivalent. | | | |
    | | Contraindications | lt is recommended not to treat patients
    with a cardiac pacemaker or a defibrillator
    with this product. The functionality of
    these devices may be affected by the high
    frequencies of the ultrasonic oscillations. | Ultrasonic oscillations may prevent
    cardiac pacemakers and defibrillators
    from functioning properly. Therefore, we
    recommend that patients with a cardiac
    pacemaker or a defibrillator should not
    be treated with this product | Same. | | | |
    | Substantial Equivalence Table | | | | | | | |
    | | | Proposed Device
    (PIEZON BUILT-IN KIT & PIEZON
    BUILT-IN KIT LED | Predicate Device
    (PIEZON 150) | Explanation of
    Variation | | | |
    | nological Characterist | Anatomical sites | Teeth and soft tissues in the
    mouth. | Teeth and soft tissues in the mouth | Same. | | | |
    | | Specific Treatment site | Supragingival | Supra and Subgingival | Equivalent. | | | |
    | | Contact duration | Limited ≤ 24 hours | Limited ≤ 24 hours | Same. | | | |
    | | Biocompatibility | Biocompatible | Biocompatible | Same. | | | |
    | | Patient Contact
    Material | Stainless Steel
    bbSu
    EPDM
    Stainless steel: AISI 316L
    Titanium
    coc | Stainless Steel
    PPSU
    EPDM
    Stainless steel: AISI 316L
    Titanium
    coc | Same. | | | |
    | | Sterility | Provided non-sterile | Provided non-sterile | Same. | | | |
    | | Shelf life | unrestricted | unrestricted | Same. | | | |
    | | General purpose | dental cleaning and periodontal
    (gum) therapy | dental cleaning and periodontal (gum)
    therapy | Same. | | | |
    | | Treatment | Ultrasonic Scaling | Ultrasonic Scaling | Same. | | | |
    | | Mechanism of
    treatment | application of an ultrasonic
    vibrating scaler tip to the teeth | application of an ultrasonic vibrating scaler
    tip to the teeth | Same. | | | |
    | | Service pressure to the
    turbine connection:
    Water | 1 to 2.2 bar (1000-2200 hPa) with
    a service flow of 50-80 ml/min.) | 1 to 2.2 bar (1000-2200 hPa) with a service
    flow of 50-80 ml/min.) | Same. | | | |
    | | Service pressure to the
    turbine connection: Air | Static pressure 2.7 to 3.5 bar
    (2700-3500 hPa | Static pressure 2.7 to 3.5 bar (2700-3500
    hPa | Same. | | | |
    | | Electric power supply | 24 VAC ± 10%
    33 VDC + 10%
    ● | 100-240 VAC
    ●
    50-60Hz
    ●
    ●
    30VDC | Equivalent. | | | |
    | | Ultrasonic generator | EJ-110F/A (configuration of EJ-
    110A/D) | EJ-110A/D | Same | | | |
    | | Maximum power
    output | 8 Watt | 8 Watt | Same | | | |
    | | Frequency | 24 to 32 kHz | 24 to 32 kHz | Same | | | |
    | | Mode | Continuous | Continuous | Same | | | |
    | | Water delivery system | Connection to external water
    supply | Connection to external water supply | Same | | | |
    | | Cruise control | Yes | Yes | Same | | | |
    | | Software | ES-002 rev a, version 1.5 | ES-002 rev a, version 1.5 | Same | | | |
    | | Control Light | Option with LED driver | Option with LED driver | Same | | | |
    | | Handpiece | EN-060/OS with LED
    EN-061/OS without LED | EN-060 (FT-223#) with LED
    EN-061 (FT-215#) without LED | Same | | | |
    | | Operating conditions | +10 °C to +40 °C
    30% to 75% relative humidity
    Altitude max. 3000 | +10 °C to +40 °C
    30% to 75% relative humidity
    Altitude max. 3000 | Same | | | |
    | | Transport and storage
    conditions | -10 °C to +40 °C
    10% to 95% relative humidity
    500 hPa to 1060 hPa air pressure | -10 °C to +40 °C
    10% to 95% relative humidity
    500 hPa to 1060 hPa air pressure | Same | | | |
    | | Housing | Installed into dental chair | Stand alone device | Equivalent. | | | |

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VIII. PERFORMANCE DATA

The following performance data were provided in support of the substantial equivalence determination.

A Risk Assessment was performed to review associated risks for this configurable Piezon kit assembly which consists of parts for ultrasonic treatment that are incorporated into a dental unit (chair). This initial risk assessment includes clinical and device specific risks for the PIEZON BUILT-IN KIT alone. An additional risk analysis was performed to address the risk of the product as a subsystem of a treatment unit (dental chair) to include any additional or changed risks that arise from the inclusion of the kit as a component of a dental chair. The combination of these two Risk Analyses were prepared to determine the necessary safety measures in design and manufacturing. The risks related to all applicable hazards which were identified for the PIEZON BIK have been reduced to the acceptable level by mitigation. Therefore, all residual risks postmitigation have been deemed acceptable for this design.

There are no changes to any functional specifications or components included in this submission. The proposed device and the predicate device are both manufactured using the same internal componentry, and the same attached accessories; the only difference is that instead of housing the device for stand alone use, the componentry is installed into a dental chair.

Biocompatibility

Biocompatibility assessment was performed according to ISO 10993-1 and no testing was necessary since all patient contacting components are identical to the cleared predicate – Piezon 150 (K132443).

Electrical Safety and Electromagnetic Compatibility Testing:

Electrical Safety and Electromagnetic Compatibility are equivalent to the predicate device based on IEC 60601-1 & IEC 60601-1-2. All tests passed and conformance is confirmed.

Integration Testing:

To verify that the removal of the housing unit and incorporation into a dental chair does not impact the performance of the BIK, functional testing was completed on the integrated product to confirm product functionality. Integration testing includes both verification of device installation into the chair as per installation specifications and confirmation of product functionality.

All tests were successfully performed and all acceptance criteria were met, thus confirming that the PIEZON BUILT-IN KIT and the PIEZON BUILT-IN KIT LED satisfactorily meet requirements. No new questions of safety and effectiveness were identified during review of Risk Management documentation or during execution of testing.

IX. CONCLUSIONS

Based on the information and supporting documentation provided in the premarket notification, the PIEZON BUILT-IN KIT and the PIEZON BUILT-IN KIT LED are substantially

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equivalent to the cited predicate device. Testing demonstrates that the PIEZON BUILT-IN KIT fulfills prospectively defined design and performance specifications.