← Product Code [EBW](/submissions/DE/subpart-e%E2%80%94surgical-devices/EBW) · K161213
# XSmart iQ (K161213)
_Dentsply Sirona · EBW · Feb 10, 2017 · Dental · SESE_
**Canonical URL:** https://fda.innolitics.com/submissions/DE/subpart-e%E2%80%94surgical-devices/EBW/K161213
## Device Facts
- **Applicant:** Dentsply Sirona
- **Product Code:** [EBW](/submissions/DE/subpart-e%E2%80%94surgical-devices/EBW.md)
- **Decision Date:** Feb 10, 2017
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 872.4200
- **Device Class:** Class 1
- **Review Panel:** Dental
- **Attributes:** Therapeutic
## Intended Use
XSmart iQ is a cordless motor hand-piece with torque control used for driving files in both reciprocating and continuous rotation mode during an endodontic procedure.
## Device Story
XSmart iQ is a cordless endodontic motor hand-piece; utilizes a motor hand-piece, contra angle, and Apple iPad Mini® console; communicates via Bluetooth 4.0 low energy. Dentist operates hand-piece; iPad Mini® with Endo iQ app displays motor parameters, treatment statistics, and patient records; provides real-time graphs and images. Torque control feature prevents file over-torque by reversing direction if limits are exceeded. Device facilitates endodontic procedures by driving files with adjustable speed/torque settings; improves maneuverability via cordless design and compact contra angle. Output affects clinical decision-making by providing controlled rotation/reciprocation and monitoring treatment parameters. Benefits include enhanced control, reduced risk of file breakage, and digital documentation of endodontic treatments.
## Clinical Evidence
No clinical data. Substantial equivalence supported by non-clinical bench testing, including biocompatibility (ISO 10993-5, ISO 7405), electrical safety (IEC 60601-1), EMC (IEC 60601-1-2), and performance testing (ISO 14457). Endurance testing (500 hours runtime, 1,600 contra angle cycles) and battery capacity evaluation confirmed device reliability. Usability validated per IEC 62366.
## Technological Characteristics
Cordless motor hand-piece; PBT/PET blend, 316L stainless steel, silicone materials. Brushless motor; 3.6V 2000mAh Li-ion battery. Bluetooth 4.0 connectivity. Contra angle (ISO 1797-1:2011 Type 1) with 6:1 reduction. Software-controlled torque/speed settings. Sterilization via validated reprocessing. Complies with IEC 60601-1, IEC 80601-2-60, and ISO 14457.
## Regulatory Identification
A dental handpiece and accessories is an AC-powered, water-powered, air-powered, or belt-driven, hand-held device that may include a foot controller for regulation of speed and direction of rotation or a contra-angle attachment for difficult to reach areas intended to prepare dental cavities for restorations, such as fillings, and for cleaning teeth.
## Predicate Devices
- e3 Torque Control Motor ([K103653](/device/K103653.md))
## Reference Devices
- W&H contra angle ([K972436](/device/K972436.md))
- W&H Service Oil F1 ([K010127](/device/K010127.md))
## Submission Summary (Full Text)
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
February 10, 2017
Dentsply Sirona Helen Lewis Director Corporate Regulatory Affairs 221 West Philadelphia Street Suite 60 York, Pennsylvania 17404
Re: K161213
Trade/Device Name: XSmart iQ Regulation Number: 21 CFR 872.4200 Regulation Name: Dental Handpiece And Accessories Regulatory Class: Class I Product Code: EBW Dated: January 13, 2017 Received: January 17, 2017
Dear Helen Lewis:
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 (800) 638-2041 or (301) 796-7100 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 (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Michael J. Ryan -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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
# Indications for Use
510(k) Number (if known)
K161213
Device Name XSmart iO
Indications for Use (Describe)
XSmart iQ is a cordless motor hand-piece with torque control used for driving files in both reciprocating and continuous mode during an endodontic procedure.
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) |
|-----------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------|
|-----------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------|
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# K161213
#### 510(k) SUMMARY
Submitter Information:
Dentsply Sirona 221 West Philadelphia Street Suite 60W York, PA 17401
| Contact Person: | Helen Lewis |
|-------------------|--------------------------------|
| Telephone Number: | 717-487-1332 |
| Fax Number: | 717-849-4343 |
| Email Address: | helen.lewis@dentsplysirona.com |
Date Prepared: February 9, 2017
#### Device Name:
| • Proprietary Name: | XSmart iQ |
|------------------------|-----------------------------------|
| • Classification Name: | Dental hand-piece and accessories |
| • CFR Number: | 872.4200 |
| • Device Class: | II |
| • Product Code: | EBW |
#### Predicate Device:
| Predicate Device Name | 510(k) | Company Name |
|-------------------------|---------|-----------------|
| e3 Torque Control Motor | K103653 | Dentsply Sirona |
#### Description of Device:
The XSmart iQ is a cordless motor hand-piece having a power stage (motor hand-piece, gears and power supplier), a console based on an Apple iPad Mini® and a communication system (Bluetooth). The motor parameters can be transferred, stored and displayed via a dedicated iPad Mini® application (Endo iQ app), connected to the cordless motor hand-piece through a Bluetooth communication protocol.
Device components (including accessories):
- Motor hand-piece support and case ●
- Motor hand-piece
- Contra angle
- Spray nozzle (used for lubrication)
- iPad Mini® Protective case (Rubber Plugs and Protective case opener) ●
- AC adapter ●
- Getting started guide
- iPad Mini® with Endo iQ iOS App (not part of the kit) ●
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The contra angle is an attachment to motor hand-piece and is physically manufactured by W&H. The contra angle is specific to XSmart iQ motor hand-piece. The contra angle is designed to transmit the rotational movement of the motor axle to the shank of a bur or file that will be inserted into the output end of the contra angle. The output end of the contra angle contains chuck systems to accommodate standardized bur and file shanks. The contra angle is compatible with rotary and reciprocating files, with a 2.35 mm shaft conforming to ISO 1797-1:2011, Type 1.The contra angle is designed to be used for driving files in both reciprocating and continuous rotation mode during an endodontic procedure.
### Indications for Use:
XSmart iQ is a cordless motor hand-piece with torque control used for driving files in both reciprocating and continuous rotation mode during an endodontic procedure.
### Substantial Equivalence:
Technological similarities and differences are as follows:
| Table 5.1 Comparison between e3 Torque Control Motor (K103653) and XSmart iQ | | | | |
|------------------------------------------------------------------------------|------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| No | Feature | Predicate Device | Proposed Device | Similarities/Differences |
| | | e3 Torque Control Motor | XSmart iQ | |
| | | K103653 | (K161213) | |
| 1 | Indication
for Use | The e3 Torque Control
Motor (K103653) is a
medical device designed
for use by dentists for use
with dental root canal
instruments in continuous
rotation with torque
control or in reciprocating
movement. | XSmart iQ is a cordless
motor hand-piece with
torque control used for
driving files in both
reciprocating and
continuous rotation mode
during an endodontic
procedure. | No differences. |
| 2 | Features | Corded motor hand-piece | Cordless motor hand-piece | |
| | | | | No differences. |
| | | Continuous rotation and
reciprocating movement | Continuous rotation and
reciprocating movement | |
| | | Can be controlled by LED
console or foot pedal | The motor parameters can
be transferred, stored and
displayed via an Apple iPad
Mini® application (Endo iQ
app), via Bluetooth
connection and controlled
by the push button on the
motor hand-piece. | XSmart iQ motor hand-
piece is controlled by push
button on the motor hand-
piece, while e3 Torque
Control Motor is
controlled by LED
console and foot pedal. |
| | | USB connection for
software updates | Bluetooth connection for
software updates | XSmart iQ uses Bluetooth
to connect with iPad
Mini® and to update the
firmware while e3 Torque
Control Motor uses USB
port to update the
firmware. |
| Table 5.1 Comparison between e3 Torque Control Motor (K103653) and XSmart iQ | | | | |
| No | Feature | Predicate Device | Proposed Device | Similarities/Differences |
| | | e3 Torque Control Motor | XSmart iQ | |
| | | K103653 | (K161213) | |
| | | The torque control feature
prevents the rotary file
from exceeding required
torque strength | The torque control feature
prevents the rotary file from
exceeding required torque
strength | No differences. |
| 3 | Console | LED console display with
membrane keypad | iPad Mini® display
with iPad Mini® application
(Endo iQ app) | iPad Mini® application
gives interactive
information (real time
graphs, images) and
access to pre- and post-
operation information. |
| | | LED screen for visual
selection of
preprogrammed setting or
for preforming customized
settings | iPad Mini® application
(Endo iQ app) with pre-
defined torque and speed
settings. | |
| | | Control unit has keypad
interface for selection of
desired functions which
are as follows:
1. To switch device on
(LED on) and off (LED
off).
2. To show battery status;
3. To scroll right/left in
the bottom row of the
display through the file
system, file, torque and
speed fields. Also used for
navigation of menu
functions. | A user management that can
be used for following:
1. To edit user profile
2. To log out and change
user
3. statistics about
application
4. Pop-up menu that
contains parameter,
statistics
5. Record treatment with
treatment notes
6. Treatment reports
allows user to:
• Create, edit or
delete a patient.
• View, edit or delete
the treatments
associated with the
patients | |
| 4 | Safety
Mechanisms | The e3 Torque Control
Motor has safety
mechanisms for
preventing the file being
over-torqued while in
operation by
implementing a torque
control feature that will
reverse the direction of the
file if the torque exceeds a
predefined limit. | XSmart iQ has safety
mechanisms for preventing
the file being over-torqued
while in operation by
implementing a torque
control feature that will
reverse the direction of the
file if the torque exceeds a
predefined limit | No differences. |
| 5 | Manufacturer | Dentsply Sirona /ATR | Dentsply Sirona
/ATR/W&H | No differences. |
| Table 5.1 Comparison between e3 Torque Control Motor (K103653) and XSmart iQ | | | | |
| No | Feature | Predicate Device
e3 Torque Control Motor
K103653 | Proposed Device
XSmart iQ
(K161213) | Similarities/Differences |
| 6 | Dimensions | 203.2 mm X 76.2mm X
76.2mm | 206 mm X 24.6 mm X 24.8 mm | It facilitates the motor
hand-piece
maneuverability in tight
spaces |
| Composition of Materials | | | | |
| 7 | Materials of
Motor Hand-
Piece | PC /ABS blend
PC-Polycarbonate
ABS- Acrylonitrile
butadiene Styrene | PBT/PET blend
(polybutylene terephthalate/
polyethylene terephthalate)
stainless steel 316L
silicone | Materials of XSmart iQ
motor hand-Piece are
more resistant to high-
level disinfectant
solutions. |
| Technical Specifications | | | | |
| 8 | Type of
Chuck | Push button | Push button | No differences. |
| 9 | Coupling
Dimensions | 2.35 mm, according to
ISO 1797-1/-2 | 2.35 mm, according to
ISO 1797-1/-2 | No differences. |
| 10 | Types of
Connectors | ISO 1797-1/-2 | ISO 1797-1/-2 | No differences. |
| 11 | Lubricant
Delivery
System | Spray nozzle | Spray nozzle | No differences. |
| 12 | Shank Length | ISO 1797-1/-2, latching | ISO 1797-1/-2, latching | No differences. |
| 13 | Reduction
Rate | 6:1 | 6:1 | No differences. |
| 14 | Weight | About 2 pounds(including
LED console) | About 0.4 pounds | XSmart iQ motor hand-
piece is lighter in weight
as compared to e3 Torque
Control Motor. |
| 15 | Power Supply | Recyko Ni-MH 6 Volt
rechargeable battery | Lithium ion battery: 3.6V ,
2000 mAh | Lithium ion batteries of
XSmart iQ are of higher
capacities and relatively
low self-discharge with
low maintenance. |
| 16 | Battery
Indicator | E3 Torque Control Motor
has three different color
LED lights to display
battery charging status:
1. Green: Battery has
sufficient capacity
2. Flashing red: Battery
needs to be charged
and the device can
operate on battery
power for only a few
minutes. Before the | Motor hand-piece battery
level is displayed on iPad
Mini® application.
The motor hand-piece of
XSmart iQ has two different
color LED lights with sound
which will inform user
about the status of the
battery.
1. All LEDs off- The
battery is completely flat
2. Green LED light-
Battery is completely | e3 Torque Control Motor
has Flashing orange LED
light when battery is
charging while XSmart iQ
motor hand-piece has
green LED light when
charging. Also XSmart iQ
has different audible
signals as compared to e3
Torque Control Motor
which make user aware
about different battery
situations. |
| No | Feature | Predicate Device | Proposed Device | Similarities/Differences |
| | | e3 Torque Control Motor
K103653 | XSmart iQ
(K161213) | |
| | | motor switches off, there is an audible warning signal
3. Flashing orange: The orange LED shows that the battery is charging. | charged or enough battery available to complete the treatment.
3. Red LED light and audible signal with one short beep- battery charge level is low.
4. Red LED light with three-second beep- battery charge level is critical. | |
| 17 | Charger
Power Supply | AC 100-240 Volts | AC 100-240 Volts | No differences. |
| 18 | Frequency of Supply
Voltage | 47-63 Hz | 50-60 Hz | XSmart iQ motor hand-piece operates at a narrow frequency range of supply voltage while e3 Torque Control Motor hand-piece operates at broad frequency range of supply voltage. |
| 19 | Torque Range | 20-410 gram-cm | 50-510 gram-cm | More torque of the XSmart iQ motor hand-piece gives more energy/power during endodontic treatment as compared to e3 Torque Control Motor. |
| 20 | Speed Range of the Micro
Motor Shaft | 250-1000 RPM (in rotary mode) | 1200 - 5100 RPM (in rotary mode) | More speed of XSmart iQ motor hand-piece produces more power which delivers constant torque. |
| 21 | Operating
Mode | Rotary and reciprocating | Rotary and reciprocating | No differences. |
| 22 | Transport and
Storing
Conditions: | Ambient temperature: -20°C - +50°C (-4°F - 122°F)
Relative humidity : 20-90% | Ambient temperature: -20°C - +50°C (-4°F - 122°F)
Relative humidity: 20% - 80% | No differences. |
| 23 | Bluetooth | No Bluetooth | Bluetooth 4.0 low energy | Bluetooth is a communication mean for XSmart iQ motor hand-piece to connect with iPad Mini® and update |
| Table 5.1 Comparison between e3 Torque Control Motor (K103653) and XSmart iQ | | | | |
| No | Feature | Predicate Device | Proposed Device | Similarities/Differences |
| | | e3 Torque Control Motor
K103653 | XSmart iQ
(K161213) | |
| 24 | Micro Motor | Brushless | Brushless | No differences. |
| 25 | Speed and
Torque
Adjustable | 40 Torque Settings, 75
speed steps | 50 Torque setting
60 speed steps | More speed and torque
settings of XSmart iQ
gives more options |
| 26 | Own Settings
Can Be Saved | Yes | Yes | No differences. |
| 27 | Auto Stop
Reverse | Yes | Yes | No differences. |
| 28 | Reverse
Signal | Yes | Yes | No differences. |
| 29 | Torque
Warning
Signal | Yes | Yes | No differences.…
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**Source:** [https://fda.innolitics.com/submissions/DE/subpart-e%E2%80%94surgical-devices/EBW/K161213](https://fda.innolitics.com/submissions/DE/subpart-e%E2%80%94surgical-devices/EBW/K161213)
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