(196 days)
No
The summary describes a multi-functional dental device combining standard endodontic tools (motor, obturator, apex locator, ultrasonic handpiece) and mentions standard performance and safety testing, but does not mention any AI or ML capabilities.
Yes
The device is described as combining an endo motor to clean the root canal, a dental obturator to fill, an electronic apex locator, and an ultrasonic handpiece for root canal cleaning and preparation, all of which are direct interventions in the human body for treatment purposes.
Yes
The device includes an electronic apex locator to locate the file tip in the root canal, which is a diagnostic function, and its accuracy for apex locating is provided as a key metric.
No
The device description clearly states it is a "standalone AC-powered dental control unit with a touch display to which multiple hand-held dental handpieces...can be connected." It also mentions "key hand-held components like handpieces or endodontic tools" and performance studies including electrical safety, electromagnetic compatibility, and coupling between handpieces and motors, all indicating a physical hardware component beyond just software.
Based on the provided information, the EndoPilot2 systems are not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use clearly states that the device is used for "cleaning the root canal," "filling and pressurizing," "locating the file tip in the root canal," and "root-canal cleaning and preparation." These are all procedures performed directly on the patient's body (in vivo) within the root canal.
- Device Description: The description reinforces that it's a "dental control unit" with "hand-held dental handpieces" used for "root canal preparation" and "root-canal filling."
- Lack of In Vitro Activity: There is no mention of the device being used to examine specimens derived from the human body (like blood, tissue, or other fluids) outside of the body (in vitro).
IVD devices are specifically designed to perform tests on samples taken from the body to provide information about a person's health. The EndoPilot2 operates directly within the patient's root canal.
N/A
Intended Use / Indications for Use
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.
Product codes
ELC, EKX, EKR, LQY
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Root canal
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Trained dental professionals in professional health care facilities.
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)
Non-Clinical Performance Data
To demonstrate the performance of EndoPilot²and to show substantial equivalence to the predicate device, Schlumbohm GmbH & Co. KG completed a number of non-clinical performance tests. Results confirm that the design inputs, function and performance specifications for the device are met. The EndoPilot® systems passed the testing in accordance with internal requirements, national standards, and international standards shown below, supporting its performance, and its substantial equivalence to the predicate device.
- . Biocompatibility evaluation per ISO 10993-1 assessed the risk for biocompatibility testing for cytotoxicity, sensitization and irritation to ISO 10993-5, 10; PASSED
- . Electrical safety testing per IEC 60601-1 and IEC 80601-2-60, PASSED required testing
- Electromagnetic Compatibility testing per IEC 60601-1-2 and IEC 61000-3-2, IEC 61000- . 4-2, IEC 61000-4-3, IEC 61000-4-4, IEC 61000-4-5, IEC 61000-4-6, IEC 61000-4-11, PASSED required testing
- . Reprocessing validation (cleaning and sterilization) per the FDA Guidance Document "Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling."
- . Coupling between handpieces and motors connected to dental units follows ISO 3964 and ISO 14457; all specifications dimensions, tolerances and the extraction force requirements were met
- . Software verification and validation testing has been completed on a functional level for a Moderate Level of Concern software including system compatibility testing, risk analysis per IEC 62304 and FDA Guidance "Content of Premarket Submissions for Management of Cybersecurity in Medical Devices, Guidance for Industry and Food and Drug Administration Staff" to address possible hazards, mitigations, and design considerations pertaining to intentional and unintentional cybersecurity risks associated with the device, , PASSED required testing
- Usability engineering testing per IEC 62366-1, PASSED
- Risk Management per EN ISO 14971, all requirements were met and risks reduced as far as possible.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Accuracy of Apex Locating point
§ 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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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
1
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 (1-800-638-2041 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
2
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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3
510(k) Summary
K202906
EndoPilot2
1. Submission Sponsor
Schlumbohm GmbH & Co. KG Klein Floyen 8-10 D-24616 Brokstedt, Schleswig-Holstein , GERMANY Phone: +49-(0)4324-8929-0 Contact: Gerald Schlumbohm , Managing Director E-mail: gs@schlumbohm.de
2. Submission Correspondent
Emergo Global Consulting, LLC 2500 Bee Cave Road Building 1, Suite 300 Austin, TX 78746 Office Phone: (512) 327-9997 Email: LST.AUS.ProjectManagement@ul.com 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 |
| EKX direct drive, AC-powered handpiece | |
| EKR endodontic plugger, root canal | |
| LQY root apex locator (unclassified), | |
| Class: | Class II |
| Classification Panel: | Dental |
4
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.
5
Table 5A – Comparison of Characteristics between Subject Device and Predicate Device EMS-200
| Attribute | SUBJECT DEVICE | PREDICATE DEVICE /
510(k) HOLDER (K153285) | Device
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
EKR, endodontic plugger, root canal
LQY, root apex locator (unclassified)
872.4850 Ultrasonic scaler
ELC Ultrasonic scaler | NA | See second
predicate in
Table 5B |
| Indications for 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 assist the
operator 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. | The EMS-200 is a dental device
which combines in a single LCD
unit an endo motor which ablates
the tooth to expand the root
canal, a dental obturator to fill
and pressurize various shaped
packaging elements and an
electronic apex locator which
assists the operator the location
of the front tip in the root canal,
for use by trained dental
professionals. | Similar
The difference in
indications for
use result out of
the different
design and
modules used
for both devices.
The intended
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)
Obturation Unit: to fill and pressurize various shaped packing elements
(Warming up by a resistance-wire)
Apex locator: to ensure the location of the front tip in root canal through
changes of electric resistance value into one unit (Electrical impedance)
Display: displayed through a single touch screen | | Same |
| AC/DC
Power
supply | AC: 100-240 V, 50/60 Hz
DC: 12 V, 1.5 A | AC: 100-240 V, 50/60 Hz
DC: 12 V, 5.0 A | Similar
Small DC
difference results
out of the lower
power
consumption for
EndoPilot2system
power adapters |
| Battery Operated | Yes, Li-Ion battery, 7.2 V,
power output 48 Wh | no | Different
Battery tested for
IEC 62133 andan
UN 38.3 Test |
| Attribute | SUBJECT DEVICE | PREDICATE DEVICE /
510(k) HOLDER (K153285) | K202906
Device
Comparison |
| Manufacturer | Schlumbohm GmbH & Co. KG | Meta Systems Co., Ltd. | |
| Trade Name | EndoPilot2 | EMS-200 | |
| Components
for
systems | 1) Control unit with display panel (touch
screen), 5 connecting sockets, a microSD
slot, power supply and wireless foot switch
2) Apex cable set (Lip-clip, Cap for Lip-clip,
Cable for file clamp, File clamp, Retainer
for apex cable, measuring cable)
3) Contra-angle for apex measurement
4) Endodontic Motor with apex measuring
contact
5) DownPack (D-Pack) handpiece with LED
indicator
6) BackFill handpiece (K042828)
7) Ultrasonic handpiece, Ultrasonic
Module (K050895) | 1) Control unit with display panel
(touch screen), 4 connecting
sockets, power supply
2) Electronic apex locator and
accessories (lip holder, cable
assembly and 2 kinds of file
holder).
3) Contra-angle for apex
measurement
4) Endodontic-motor Handpiece
with apex measuring contact
5) Obturation Unit (K031664)
6) BackFill handpiece included in
Obturation Unit (see 5)
7) NA | Similar
The
small
differences
in
design do not
raise
new
questions
of
substantial
equivalence |
| Processing
(reuse of components
sterilized by user) | To be reprocessed in the dental practice before re-use. | | Similar
Manuals include
reprocessing
instruction
based on ISO
17664/17665-1 |
| Electrical Safety | IEC 60601-1 | IEC 60601-1 | Same |
| Protection type and
level against electric
shock | Class II equipment, Type BF applied part | Class I equipment, Type B applied
part | Similar
Equivalent
technology is
used, |
| Electromagnetic
Compatibility
Electric Safety Tests | IEC 60601-1-2
IEC 61000-3 series
IEC 61000-4 series (2,3,4,5,6,8,11)
IEC 80601-2-60 | IEC 60601-1-2
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
Device
Function | LCD Touchscreen for display of working
components | LCD Touchscreen for display of
working components, stand | Similar |
| Functional
Specification | All main function can be selected directly at the start screen
The device switches off after a longer period of non-operation | | Same |
| Accessory
Foot switch Function | Single wireless footswitch or optional
Twin wireless foot switch | NA, Function is started by pressing
a switch by finger | Different
The foot switch
provides |
| Wireless
connection/Bluetooth | 2.402-2.480 GHz, TX Power: +7 dBm | NA | different
method to start
the device |
| Attribute | SUBJECT DEVICE | PREDICATE DEVICE /
510(k) HOLDER (K153285) | K202906
Device
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
changes of electric resistance value | | Same |
| Apex locator | Electronic apex locator (Schlumbohm) | Electronic apex locator | Same |
| Apex cable set
components
(material) | Lip clip (Stainless-Steel)
cap for lip-clip plug socket (POM-C)
58 mm 2mm | Lip holder (Stainless steel)
64 mm 2 mm | Similar
Same material
used for main
components
small difference
in design does
not impact
the device |
| | File clamp (USP Plastic Class VI),
cable for file clamp (TPR Plastic Class VI)
Length 65 mm , Diameter 12 mm
Measuring cable (PVC), 1.5 m twin cable
Retainer for apex cable (Stainless steel)
(rest at the device) | File holder B (Silicone rubber &
PBT),With cable
Length 68 mm , Diameter 9.5 mm
Probe cord (PVC), 1.8 m twin cable
No retainer | |
| Functional
Specification | Accuracy of
Apex Locating point