EndoPilot2

K202906 · Schlumbohm GmbH & Co. KG · ELC · Apr 13, 2021 · Dental

Device Facts

• Record ID: K202906
• Device Name: EndoPilot2
• Applicant: Schlumbohm GmbH & Co. KG
• Product Code: ELC · Dental
• Decision Date: Apr 13, 2021
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.4850
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The EndoPilot2 systems are dental devices which combine in a single control unit an endo motor to clean the root canal, a dental obturator to fill and pressurize, an electronic apex locator to locate the file tip in the rot canal and an ultrasonic-handpiece for root-canal cleaning and preparation. The EndoPilot is intended solely for use by trained dental professional health care facilities on patients that need root-canal-treatment.

Device Story

EndoPilot2 is a standalone AC-powered dental control unit with a touch display, designed for use by dental professionals in clinics. It integrates multiple handpieces for root canal procedures: an endo motor for cleaning, an obturator for filling/pressurizing, an electronic apex locator for file tip positioning, and an ultrasonic handpiece for cleaning/preparation. The apex locator functions via electrical impedance changes. The device uses a modular design allowing various handpieces to connect to the central unit. It features a wireless footswitch for activation. The clinician operates the system via the touchscreen to select functions and monitor parameters. By consolidating these tools into one unit, the device streamlines endodontic workflows, potentially improving procedural efficiency and accuracy in root canal treatments.

Clinical Evidence

Bench testing only. Evidence includes biocompatibility (ISO 10993), electrical safety (IEC 60601-1, IEC 80601-2-60), EMC (IEC 60601-1-2), reprocessing validation (ISO 17664/17665), mechanical coupling (ISO 3964/14457), software V&V, usability engineering (IEC 62366-1), and risk management (ISO 14971).

Technological Characteristics

Standalone AC-powered control unit with LCD touchscreen. Components: endo motor, obturator, apex locator, ultrasonic handpiece. Materials: stainless steel, POM-C, USP Plastic Class VI, TPR, PVC. Connectivity: Bluetooth 4.1 (2.402-2.480 GHz). Power: 100-240V AC, 50/60Hz; 12V DC. Ultrasonic frequency: 27-33 kHz. Apex locator accuracy: < ±0.5 mm. Sterilization: per ISO 17664/17665-1.

Indications for Use

Indicated for patients requiring root-canal treatment. Intended for use by trained dental professionals in professional health care facilities.

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-200 (K153285)
• SUPRASSON P5 NEWTRON (K050895)

Reference Devices

• SUPRASSON P5 Booster (K961158)
• SP NEWTRON Module (K033764)
• Obtura Heated Gutta Percha System (K042828)
• Endodontic Obturation Unit (K031664)

Submission Summary (Full Text)

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April 13, 2021

Schlumbohm GmbH & Co. KG % Oliver Eikenberg, PhD Senior Consultant QA/RA Emergo Global Consulting, LLC 2500 Bee Cave Road, Building 1, Suite 300 Austin, Texas 78746

Re: K202906

Trade/Device Name: EndoPilot2 Regulation Number: 21 CFR 872.4850 Regulation Name: Ultrasonic Scaler Regulatory Class: Class II Product Code: ELC, EKX, EKR, LQY Dated: March 2. 2021 Received: March 9, 2021

Dear Oliver Eikenberg:

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 mav. 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.

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

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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 (OS) 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 [phone] or 301-796-7100).

Sincerely,

# Bobak Shirmohammadi -S

For Michael Adjodha Assistant Director DHT1B: Division of Dental Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory. ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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### Indications for Use

510(k) Number (if known) K202906

Device Name EndoPilot2

Indications for Use (Describe)

The EndoPilote systems are dental devices which combine in a single control unit an endo motor to clean the root canal, a dental obturator to fill and pressurize, an electronic apex locator to locate the file tip in the rot canal and an ultrasonic-handpiece for root-canal cleaning and preparation.

The EndoPilot is intended solely for use by trained dental professional health care facilities on patients that need root-canal-treatment.

| Type of Use (Select one or both, as applicable) | |
|-------------------------------------------------|---------------------------------------------|
| Prescription Use (Part 21 CFR 801 Subpart D) | Over The Counter Use (21 CFR 801 Subpart C) |

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

## K202906

# EndoPilot2

#### 1. Submission Sponsor

Schlumbohm GmbH & Co. KG Klein Floyen 8-10 D-24616 Brokstedt, Schleswig-Holstein , GERMANY Phone: [phone] Contact: Gerald Schlumbohm , Managing Director E-mail: [e-mail]

#### 2. Submission Correspondent

Emergo Global Consulting, LLC 2500 Bee Cave Road Building 1, Suite 300 Austin, TX 78746 Office Phone: [phone] Email: [e-mail] Contact: Oliver Eikenberg, PhD Title: Senior Consultant, Quality & Regulatory Affairs

#### 3. Date Prepared

April 12, 2021

#### 4. Device Identification

#### Trade/Proprietary Name: EndoPilot2

| Common/Usual Name: | Dental hand instrument |
|-----------------------|------------------------------------------------------------------------------------------------------------------------------------------------|
| Classification Name: | Ultrasonic Scaler |
| Regulation Number: | 21 CFR 872.4850 |
| Product Code: | ELC Ultrasonic scaler<br>EKX direct drive, AC-powered handpiece<br>EKR endodontic plugger, root canal<br>LQY root apex locator (unclassified), |
| Class: | Class II |
| Classification Panel: | Dental |

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#### 5. Legally Marketed Predicate Device(s)

For the Endodontic unit systems (applicable to all EndoPilot²model variants): Primary Predicate

Device name: EMS-200 510(k) number: K153285 Manufacturer: Meta Systems Co., Ltd., Korea

For the Ultrasonic Unit (applicable only to EndoPilot²model variant "ultra" and " ultra plus"): Reference Device

Device name: SUPRASSON P5 NEWTRON 510(k) number: K050895 Manufacturer: SATELEC-ACTEON Group

#### 6. Indication for Use Statement

The EndoPilot² systems are dental devices which combine in a single control unit an endo motor to clean the root canal, a dental obturator to fill and pressurize, an electronic apex locator to locate the file tip in the root canal and an ultrasonic-handpiece for root-canal cleaning and preparation.

The EndoPilot² is intended solely for use by trained dental professionals in professional health care facilities on patients that need root-canal-treatment.

#### 7. Device Description

The EndoPilot2 systems, including the models "comfort", "plus", "ultra plus" and the model variant under brand "CanalPro Jeni" (marketed by Distributor Coltène/Whaledent Inc. and identical for technical aspects to model EndoPilot² comfort) are standalone AC-powered dental control units with a touch display to which multiple hand-held dental handpieces for root canal preparation (Apex measurement, EndoMotor, Ultrasonic handpiece) and/or root-canal filling (DownPack, BackFill handpiece) can be connected.

These multifunctional devices are intended for use by professionals in the dental clinic use environment. Based on the modular concept of these EndoPilot2 systems different handpieces can be combined with the control unit and different device variants (systems) of the EndoPilot²exist. The key hand-held components like handpieces or endodontic tools of the EndoPilot² are medical devices commercially available by themselves and have separate FDA registration or clearance for marketing in the US.

#### 8. Substantial Equivalence Discussion

The following tables compare the EndoPilot2 to the predicate devices EMS-200 and SUPRASSON P5 NEWTRON with respect to indications for use, principles of operation, technological characteristics, components, and performance, and forms the basis for the determination of substantial equivalence. The subject device does not raise any new questions of safety or effectiveness as compared to the predicate devices.

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### Table 5A – Comparison of Characteristics between Subject Device and Predicate Device EMS-200

| Attribute | SUBJECT DEVICE | PREDICATE DEVICE /<br>510(k) HOLDER (K153285) | Device<br>Comparison |
|-------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Manufacturer | Schlumbohm GmbH & Co. KG | Meta Systems Co., Ltd. | |
| Trade Name | EndoPilot2 | EMS-200 | |
| Regulation Number | 872.4200 Dental Handpiece and Accessories | | Same |
| Regulation Name | EKX, direct drive, ac-powered handpiece | | |
| Product Codes | 872.4565 Dental hand instrument<br>EKR, endodontic plugger, root canal<br>LQY, root apex locator (unclassified)<br>872.4850 Ultrasonic scaler<br>ELC Ultrasonic scaler | NA | See second<br>predicate in<br>Table 5B |
| Indications for Use | The EndoPilot2 systems are dental devices<br>which combine in a single control unit an<br>endo motor to clean the root canal, a<br>dental obturator to fill and pressurize, an<br>electronic apex locator to assist the<br>operator to locate the file tip in the root<br>canal and an ultrasonic-handpiece for root-<br>canal cleaning and preparation.<br>The EndoPilot2 is intended solely for use<br>by trained dental professionals in<br>professional health care facilities on<br>patients that need root-canal-treatment. | The EMS-200 is a dental device<br>which combines in a single LCD<br>unit an endo motor which ablates<br>the tooth to expand the root<br>canal, a dental obturator to fill<br>and pressurize various shaped<br>packaging elements and an<br>electronic apex locator which<br>assists the operator the location<br>of the front tip in the root canal,<br>for use by trained dental<br>professionals. | Similar<br>The difference in<br>indications for<br>use result out of<br>the different<br>design and<br>modules used<br>for both devices.<br>The intended<br>use is the same. |
| Professional Use | Dental professionals | | Same |
| Location of Use | Dental practice | | Same |
| Mode of Action | Endo-Motor: ablates the tooth to clean the root canal (rotating endo-files)<br>Obturation Unit: to fill and pressurize various shaped packing elements<br>(Warming up by a resistance-wire)<br>Apex locator: to ensure the location of the front tip in root canal through<br>changes of electric resistance value into one unit (Electrical impedance)<br>Display: displayed through a single touch screen | | Same |
| AC/DC<br>Power<br>supply | AC: 100-240 V, 50/60 Hz<br>DC: 12 V, 1.5 A | AC: 100-240 V, 50/60 Hz<br>DC: 12 V, 5.0 A | Similar<br>Small DC<br>difference results<br>out of the lower<br>power<br>consumption for<br>EndoPilot2system<br>power adapters |
| Battery Operated | Yes, Li-Ion battery, 7.2 V,<br>power output 48 Wh | no | Different<br>Battery tested for<br>IEC 62133 andan<br>UN 38.3 Test |
| Attribute | SUBJECT DEVICE | PREDICATE DEVICE /<br>510(k) HOLDER (K153285) | K202906<br>Device<br>Comparison |
| Manufacturer | Schlumbohm GmbH & Co. KG | Meta Systems Co., Ltd. | |
| Trade Name | EndoPilot2 | EMS-200 | |
| Components<br>for<br>systems | 1) Control unit with display panel (touch<br>screen), 5 connecting sockets, a microSD<br>slot, power supply and wireless foot switch<br>2) Apex cable set (Lip-clip, Cap for Lip-clip,<br>Cable for file clamp, File clamp, Retainer<br>for apex cable, measuring cable)<br>3) Contra-angle for apex measurement<br>4) Endodontic Motor with apex measuring<br>contact<br>5) DownPack (D-Pack) handpiece with LED<br>indicator<br>6) BackFill handpiece (K042828)<br>7) Ultrasonic handpiece, Ultrasonic<br>Module (K050895) | 1) Control unit with display panel<br>(touch screen), 4 connecting<br>sockets, power supply<br>2) Electronic apex locator and<br>accessories (lip holder, cable<br>assembly and 2 kinds of file<br>holder).<br>3) Contra-angle for apex<br>measurement<br>4) Endodontic-motor Handpiece<br>with apex measuring contact<br>5) Obturation Unit (K031664)<br>6) BackFill handpiece included in<br>Obturation Unit (see 5)<br>7) NA | Similar<br>The<br>small<br>differences<br>in<br>design do not<br>raise<br>new<br>questions<br>of<br>substantial<br>equivalence |
| Processing<br>(reuse of components<br>sterilized by user) | To be reprocessed in the dental practice before re-use. | | Similar<br>Manuals include<br>reprocessing<br>instruction<br>based on ISO<br>17664/17665-1 |
| Electrical Safety | IEC 60601-1 | IEC 60601-1 | Same |
| Protection type and<br>level against electric<br>shock | Class II equipment, Type BF applied part | Class I equipment, Type B applied<br>part | Similar<br>Equivalent<br>technology is<br>used, |
| Electromagnetic<br>Compatibility<br>Electric Safety Tests | IEC 60601-1-2<br>IEC 61000-3 series<br>IEC 61000-4 series (2,3,4,5,6,8,11)<br>IEC 80601-2-60 | IEC 60601-1-2<br>IEC 61000-4 series (2,3,4,5,6,8,11) | Similar |
| | Technological comparison of System Component Functions | | |
| | Control Unit and display, Apex cable set and foot switch | | |
| Display<br>Device<br>Function | LCD Touchscreen for display of working<br>components | LCD Touchscreen for display of<br>working components, stand | Similar |
| Functional<br>Specification | All main function can be selected directly at the start screen<br>The device switches off after a longer period of non-operation | | Same |
| Accessory<br>Foot switch Function | Single wireless footswitch or optional<br>Twin wireless foot switch | NA, Function is started by pressing<br>a switch by finger | Different<br>The foot switch<br>provides |
| Wireless<br>connection/Bluetooth | 2.402-2.480 GHz, TX Power: +7 dBm | NA | different<br>method to start<br>the device |
| Attribute | SUBJECT DEVICE | PREDICATE DEVICE /<br>510(k) HOLDER (K153285) | K202906<br>Device<br>Comparison |
| Manufacturer | Schlumbohm GmbH & Co. KG | Meta Systems Co., Ltd. | |
| Trade Name | EndoPilot2 | EMS-200 | |
| Apex locator (Apex cable set) | | | |
| Function | Apex location of the front tip (of the endo-file) in the root canal through<br>changes of electric resistance value | | Same |
| Apex locator | Electronic apex locator (Schlumbohm) | Electronic apex locator | Same |
| Apex cable set<br>components<br>(material) | Lip clip (Stainless-Steel)<br>cap for lip-clip plug socket (POM-C)<br>58 mm 2mm | Lip holder (Stainless steel)<br>64 mm 2 mm…