(329 days)
Not Found
No
The summary describes a mechanical dental handpiece and its intended uses, with no mention of AI, ML, or any software-driven analytical capabilities.
Yes.
The device is used for removal of carious material, reducing of hard tooth structure, cavity and crown preparations, root canal preparations, removal of fillings, processing and finishing tooth preparations, restorations for polishing teeth, and implant surgery. All these actions are therapeutic interventions.
No
Explanation: The device is a dental handpiece intended for various dental procedures such as material removal, tooth structure reduction, and implant surgery. Its descriptions focus on mechanical actions and surgical functions, not on identifying or assessing medical conditions.
No
The device description clearly details physical components like a main body, gears, tubes, and a connection mechanism, indicating it is a hardware device.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The intended uses described are all related to mechanical procedures performed directly on the tooth structure (removal of carious material, cavity preparation, root canal preparation, etc.) and bone (implant surgery). These are physical manipulations, not diagnostic tests performed on samples taken from the body.
- Device Description: The description details the mechanical function of the handpiece, how it transmits rotational force, and its components for delivering water and air. It focuses on the physical action of the device in dental procedures.
- Lack of Diagnostic Function: There is no mention of the device being used to analyze samples (blood, tissue, etc.) or to provide diagnostic information about a patient's condition.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This dental handpiece does not fit that description.
N/A
Intended Use / Indications for Use
Dental Handpiece with models of SG200, SG200L, SA100L, and CA100L, and CA100R are intended for the removal of carious material, reducing of hard tooth structure, cavity and crown preparations, root canal preparations, removal of fillings, processing and finishing tooth preparations for polishing teeth.
In addition, Dental Handpiece with models of SG200, SG200L are also intended for implant surgery such as perforating the bone, tapping and threading procedures.
Dental Handpiece is designed for use by a trained professional in the field of general dentistry.
Product codes (comma separated list FDA assigned to the subject device)
EFA
Device Description
Dental Handpiece with models of SG200, SG200L, SA100L, SA100R, CA100L, and CA100R are intended for the removal of carious material, reducing of hard tooth structure, cavity and crown preparations, root canal preparations, removal of fillings, processing and finishing tooth preparations, and restorations for polishing teeth.
In addition, Dental Handpiece with models of SG200, SG200L are also intended for implant surgery such as perforating the bone, tapping and threading procedures.
Dental Handpiece is designed for use by a trained professional in the field of general dentistry.
The proposed dental handpiece consists of the main body of a handpiece, which is used for transmitting a rotational force for the general dental treatments as well as accessory components. which are used for channeling water and air for further applications to the dental treatments. The torque transmitted from an electric micro-motor gets further transmitted to the joint part of Dental Handpiece. The rotational force is then decelerated according to the speed reducer of the gear to be transmitted to the head of the dental handpiece. The rotational force is transmitted under the permitted rotation mechanism.
The product is offered as an electrical-powered Dental Handpiece that is reusable and ergonomically shaped. The dental handpiece can be sterilized by the steam autoclave method. Through the tube and the electrical motor connected to a dental unit, the Dental Handpiece equipped with a handpiece connection according to ISO 3964 (Dentistry - Coupling dimensions for handpiece connectors - ISO 3964:1982) receive the energy for the gear, the cooling water and air for cutting treatment. Dental burs and other attachments will be used with the proposed Dental Handpiece per ISO 1797:2017 (Dentistry - Shanks for rotary and oscillating instruments).
Dental Handpiece has been developed with a full range of surgical contra angle intended to be used in implantology. The contra angle-design, size and performance of the proposed Dental Handpiece conform to ISO 14457 (2017) "Dentistry -Handpieces and motors"
The six (6) product codes and models of Dental Handpiece are SG200L, SG200, CA100L, CA100R. SA100L. SA100R.The component names and functional descriptions for critical components of Dental Handpiece are provided in the table below.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
trained professional in the field of general dentistry.
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)
Design Verification and Validation testing were performed to verify that the proposed Dental Handpiece meets the pre-determined design requirements and demonstrated design input matched with design outputs. Risk management assessment was conducted and appropriate risk mitigation measures were implemented including verifications of the effectiveness of the implemented risk control measures to mitigate the risks identified within the risk management process (per ISO 14971:2012 Medical Devices - Application of Risk Management to Medical Devices).
- Rotational Speed Testing
- Noise Testing
- Water Supplying Testing
- Light Testing
- Operation Testing
- Appearance Testing
The favorable results of the biocompatibility, design verification performance, and validation testing demonstrate conformance of the proposed Dental Handpiece to the applicable, recognized standards of FDA. The testing results further demonstrate the substantially equivalent profile as the predicate device, the proposed device are subject to the same applicable test standards under FDA's recognized standards including ISO 10993-1 (2009).
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.
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
§ 872.4200 Dental handpiece and accessories.
(a)
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.(b)
Classification. Class I.
0
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the FDA logo is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
August 25, 2020
Micro-NX Co., Ltd. % Kyungyoon Kang CEO K-Bio Solutions 589 Oakwood Drive Santa Clara, California 95054
Re: K192809
Trade/Device Name: Dental Handpiece Regulation Number: 21 CFR 872.4200 Regulation Name: Dental Handpiece And Accessories Regulatory Class: Class I Product Code: EFA Dated: May 20, 2020 Received: May 27, 2020
Dear Kyungyoon Kang:
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.
1
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 (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 medical devices and radiation-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.
For Srinivas "Nandu" Nandkumar, Ph. D. 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) K192809
Device Name Dental Handpiece
Indications for Use (Describe)
Dental Handpiece with models of SG200, SG200L, SA100L, and CA100L, and CA100R are intended for the removal of carious material, reducing of hard tooth structure, cavity and crown preparations, root canal preparations, removal of fillings, processing and finishing tooth preparations for polishing teeth.
In addition, Dental Handpiece with models of SG200, SG200L are also intended for implant surgery such as perforating the bone, tapping and threading procedures.
Dental Handpiece is designed for use by a trained professional in the field of general dentistry.
| 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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3
K192809
510(k) SUMMARY
Pursuant to Section 510(k) of Chapter V of the Federal Food, Drug, and Cosmetic Act and in accordance with subpart E of Part 807, Title 21 of the Code of Federal Regulations, MICRO-NX Co., Ltd. submits the following information as premarket notification for the proposed device, Dental Handpiece.
I . SUBMITTER
510(k) Correspondent: Kyungyoon Kang CEO, K-Bio Solutions (Kyungyoon.kang@kbiotechsolutions.com) Tel: 82-2-597-2700 (US: 812-345-7485)
Sponsor: MICRO-NX Co., Ltd. 22 Maeyeo-ro 1 gil, Dong-gu, Daegu Postal code: 41059, Republic of Korea Tel: 82-053-650-1000 Fax: 82-053-650-1005
510(k) Number: K192809 Manufacturer Contact: Sojeong Park (sojeong@micronx.co.kr) Date Prepared: August 25th, 2020
II . SUBMISSION DEVICE
- Trade Name: Dental Handpiece ●
- Common Name: Handpiece, dental
- Classification Name: Dental handpiece and accessories ●
- Regulation Number: 21 CFR 872.4200 ●
- Regulation Name: Dental handpiece and accessories
- Product Code: EFA (handpiece, belt and/or gear driven, dental) ●
- Review Panel: Dental ●
- . Regulatory Class: Class I
Traditional 510(k) Registration (There were no prior submissions for the proposed, Micro-NX Dental Handpiece, which is labeled for 5 year shelf life)
II. PREDICATE DEVICES
- SMARTmatic (K163239), Manufacturer: Kaltenbach & Voigt GmbH ●
- Anthogyr Contra Angles and Handpieces (K093894). Manufacturer: Anthogyr ●
These predicate devices have not been subject to a design-related recall.
4
IV. DEVICE DESCRIPTION
Dental Handpiece with models of SG200, SG200L, SA100L, SA100R, CA100L, and CA100R are intended for the removal of carious material, reducing of hard tooth structure, cavity and crown preparations, root canal preparations, removal of fillings, processing and finishing tooth preparations, and restorations for polishing teeth.
In addition, Dental Handpiece with models of SG200, SG200L are also intended for implant surgery such as perforating the bone, tapping and threading procedures.
Dental Handpiece is designed for use by a trained professional in the field of general dentistry.
The proposed dental handpiece consists of the main body of a handpiece, which is used for transmitting a rotational force for the general dental treatments as well as accessory components. which are used for channeling water and air for further applications to the dental treatments. The torque transmitted from an electric micro-motor gets further transmitted to the joint part of Dental Handpiece. The rotational force is then decelerated according to the speed reducer of the gear to be transmitted to the head of the dental handpiece. The rotational force is transmitted under the permitted rotation mechanism.
The product is offered as an electrical-powered Dental Handpiece that is reusable and ergonomically shaped. The dental handpiece can be sterilized by the steam autoclave method. Through the tube and the electrical motor connected to a dental unit, the Dental Handpiece equipped with a handpiece connection according to ISO 3964 (Dentistry - Coupling dimensions for handpiece connectors - ISO 3964:1982) receive the energy for the gear, the cooling water and air for cutting treatment. Dental burs and other attachments will be used with the proposed Dental Handpiece per ISO 1797:2017 (Dentistry - Shanks for rotary and oscillating instruments).
Dental Handpiece has been developed with a full range of surgical contra angle intended to be used in implantology. The contra angle-design, size and performance of the proposed Dental Handpiece conform to ISO 14457 (2017) "Dentistry -Handpieces and motors"
The six (6) product codes and models of Dental Handpiece are SG200L, SG200, CA100L, CA100R. SA100L. SA100R.The component names and functional descriptions for critical components of Dental Handpiece are provided in the table below.
| Table IV-1. Component Names and Functional Descriptions for Critical Components of | |
|---|---|
| Dental Handpiece: SG200L, SG200, CA100L, CA100R | |
| Component Name | Function |
| Components which are commonly included in the models of SG200L, SG200, CA100L, CA100R | |
| Spindle Assembly | Receives torque from Middle Gear Assembly and transmits torque to final |
| dental bur | |
| Middle Gear | |
| Assembly | Transmitting the rotational force from being Housing Assembly also |
| delivering the rotational force to the Spindle Assembly | |
| Button Assembly | Button for removal and attachment of the hand piece head |
| Head Cap | Case that wraps the Middle Gear Assembly and Housing |
| Assembly, and the Button Assembly is assembled | |
| Head | |
| Assembly | The component that is assembled Spindle Assembly, Middle Gear Assembly, |
| Button Assembly, Head Assembly | |
| Housing | |
| Assembly | Transmits the torque received from Joint Assembly to Middle Gear Assembly |
| Joint | |
| Assembly | Transmits the torque received from the motor to the Housing Assembly |
| Inner Handle | Case to fix Joint Assembly |
| Planetary Gear | |
| Assembly | The component that is assembled Housing Assembly, Joint Assembly, Inner |
| Handle | |
| Spray Adapter | Adapter to help oil fill the handpiece |
| Components only available for SG200L | |
| Optic | Optical fiber that allows light to pass from the motor's LED light source to the |
| handpiece head | |
| Angle Handle | The case of Planetary Gear Assembly, Optic, Head |
| Assembly | |
| Angle Body | |
| Assembly | The case is installed in Handle Assembly and has two parts where the light |
| passing through the optical fiber comes out and the part where the Pipe Clip | |
| can be fixed | |
| Handle Assembly | The component that is assembled Optic, Angle Handle |
| Pipe Clip | Clip to fix Outside Pipe mounted on specific groove of Angle Body Assembly |
| Y-coupling | Supply water from the external water supply line to the spray nozzle and |
| outside pipe | |
| Tube Clip | Fix the external water line to the handpiece |
| Inside Pipe | Pipes attached to the handpiece head to supply water |
| Outside Pipe | Pipes fixed to Pipe Clip pipe to supply water |
| Components only available for SG200 | |
| Angle Handle | The case of Planetary Gear Assembly, Optic, Head Assembly |
| Angle Body Assembly | The case is installed in Handle Assembly and has two parts where the light passing through the optical fiber comes out and the part where the pipe clip can be fixed |
| Spray Nozzle | Pipe for water supply mounted on the handpiece head |
| Pipe Clip | Clip to fix Outside Pipe mounted on specific groove of Angle Body Assembly |
| Y-coupling | Supply water from the external water supply line to the spray nozzle and outside pipe |
| Tube Clip | Fix the external water line to the handpiece |
| Outside Pipe | Pipes fixed to Pipe Clip pipe to supply water |
| Components only available for CA100L | |
| Handle Assembly | The component that is assembled Optic, Angle Handle |
| Angle Body Assembly | The case is installed in Handle Assembly and has two parts where the light passing through the optical fiber comes out and the part where the pipe clip can be fixed |
| Angle Handle | The case of Planetary Gear Assembly, Optic, Head Assembly |
| Optic | Optical fiber that allows light to pass from the motor's LED light source to the handpiece head |
| Irrigation Pipe Assembly | Pipes for water supply |
| Components only available for CA100R | |
| Handle Assembly | The component that is assembled Optic, Angle Handle |
| Angle Body | |
| Assembly | The case is installed in Handle Assembly and has two parts where the light |
| passing through the optical fiber comes out and the part where the pipe clip can | |
| be fixed | |
| Angle Handle | The case of Planetary Gear Assembly, Optic, Head |
| Assembly | |
| Irrigation Pipe | |
| Assembly | Pipes for water supply |
5
6
7
Table IV-2. Component Names and Functional Descriptions for Critical Components of Dental Handpiece: SA100L, SA100R
| Components which are commonly included in the models of SA100L, SA100R | |
|---|---|
| Spindle Assembly | Receives torque from motor and transmits torque to final dental bur |
| Cam | A Component to fix the bottom of Spindle Assembly |
| Inner Handle | A component that is assembled Spindle Assembly |
| Nose Cap | An outer case assembled the front part of Cam Handle Assembly |
| Cam Handle | |
| Assembly | An outer case that is assembled Nose Cap, Angle Handle. |
| Angle Handle | An outer case assembled the back part of Cam Handle Assembly |
| Irrigation Pipe | |
| Assembly | Pipes for water supply |
| Handle Fixing Bolt | Assembled and fastened at the bottom of the handpiece |
| Spray Adapter | Adapter to help oil fill the handpiece |
| Components only available for SA100L |
8
| Optic | Optical fiber that allows light to pass from the motor's LED light source to the
handpiece head |
| ------- | ---------------------------------------------------------------------------------------------------- |
|---|
V. INDICATIONS FOR USE/INTENDED USE
Dental Handpiece with models of SG200, SG200L, SA100L, SA100R, CA100L, and CA100R are intended for the removal of carious material, reducing of hard tooth structure, cavity and crown preparations, root canal preparations, removal of fillings, processing and finishing tooth preparations, and restorations for polishing teeth.
In addition, Dental Handpiece with models of SG200, SG200L are also intended for implant surgery such as perforating the bone, tapping and threading procedures.
Dental Handpiece is designed for use by a trained professional in the field of general dentistry.
VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE
Fundamental technological characteristics of MICRO-NX dental handpiece are substantially equivalent to the predicate devices, SMARTmatic and ANTHOGYR Contra angles and Handpieces as demonstrated in Table VI-1 below.
| Comparison
Category | Proposed Device:
Dental Handpiece | Predicate
Device:
SMARTmatic
(K163239) | Predicate
Device:
ANTHOGYR
Contra angles and
Handpieces
(K093894) | Substantial
Equivalence
Assessments |
|-------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use
/Indications
for Use | Dental Handpiece
with models of
SG200, SG200L,
SA100L, SA100R,
CA100L, and
CA100R are intended
for the removal of
carious material,
reducing of hard tooth
structure, cavity and
crown preparations,
root canal
preparations, removal
of fillings, processing
and finishing tooth
preparations and | The SMARTmatic
handpieces are
intended for the
removal of carious
material, reducing
of hard tooth
structure, cavity
and crown
preparations, root
canal preparations,
removal of fillings,
processing and
finishing tooth
preparations,
restorations, and
for polishing teeth | ANTH-OGYR'S
fully autoclavable
contra-angles
Implantology
Impulsion are
devices intended
for a wide
range of dental
procedures
including:
Implant surgery
such as perforating
the bone, tapping
and
threading
procedures | Intended use and
indications for use
are the same
between Dental
Handpiece and the
predicate device
of SMARTmatic
handpieces, for the
removal of carious
material, reducing
of hard tooth
structure, cavity
and crown
preparations, root
canal preparations,
removal of |
| | restorations for
polishing teeth.
In addition, Dental
Handpiece with
models of SG200,
SG200L are also
intended for implant
surgery such as
perforating the bone,
tapping and
threading procedures.
Dental Handpiece is
designed for use by a
trained professional
in the field of general
dentistry. | They are designed
for use by a trained
professional in the
field of general
dentistry. | fillings,
processing and
finishing tooth
preparations, and
restorations for
polishing teeth.
The intended use
of the predicate,
ANTHOGYR for
implant surgery
such as
perforating the
bone, tapping and
threading
procedures is the
same as the
intended use of
Micro-NX dental
handpiece for
models of SG200,
SG200L. | |
| Functional
Principle | Through the micro
motor connected to
the dental treatment
unit, the straight and
contra-angle
handpieces equipped
with a handpiece
connection according
to ISO 3964
(Dentistry - Coupling
dimensions for
handpiece connectors
- ISO 3964:1982)
receive the energy,
the cooling water and
air for treatment and
the light for
illumination the
operating area. | Through the micro
motor connected to
the dental
treatment unit, the
straight and
contra-angle
handpieces
equipped with a
handpiece
connection
according to ISO
3964 (Dentistry -
Coupling
dimensions for
handpiece
connectors - ISO
3964:1982) receive
the energy, the
cooling water and
air for treatment
and the light for
illumination the
operating area. | Through the micro
motor connected to
the dental
treatment unit, the
straight and
contra-angle
handpieces
equipped with a
handpiece
connection
according to ISO
3964 (Dentistry -
Coupling
dimensions for
handpiece
connectors - ISO
3964:1982) receive
the energy, the
cooling water and
air for treatment
and the light for
illumination the
operating area. | Same Functional
Principle |
| Dimensions | Head size-
Height: Up to 14mm
Head size-Diameter:
Up to 9mm
Length: Up to
95.80mm | Head size-Height:
Up to 13.6 mm
Head size-
Diameter: Up to
9.8 mm
Length: Up to 93.4
mm | Head size-Height:
Up to 13.02mm
Head size-
Diameter: Up to
10.07 mm
Length: Up to
104.84mm | The head size,
height, and
diameter of
MICRO-NX
Dental Handpiece
are broadly in
alignment with the |
| | | | | dimensions of the |
| | | | | predicate, |
| | | | | SMARTmatic |
| | | | | handpiece. The |
| | | | | minute differences |
| | | | | in the identified |
| | | | | dimensions do not |
| | | | | raise different |
| | | | | questions of safety |
| | | | | and effectiveness. |
| Direct
patient-
contacting
portions of
the device | All materials for
MICRO-NX Dental
Handpiece models are
listed in the raw
material table below
including chemical
composition of the
waterlines and the
patient-contacting
portions of the
device.
Biocompatible
according to ISO
10993-1 (Biological
evaluation of medical
devices - Part 1:
Evaluation and
testing within a risk
management system -
ISO 10993-1:2009) | All materials for
the SMARTmatic
models are listed
in the tables below
including chemical
composition of the
waterlines and the
patient-contacting
portions of the
device.
Biocompatible
according to ISO
10993-1
(Biological
evaluation of
medical devices -
Part 1: Evaluation
and testing within
a risk management
system - ISO
10993-1:2009) | Biocompatible
according to ISO
10993-1
(Biological
evaluation of
medical devices -
Part 1: Evaluation
and testing within
a risk management
system - ISO
10993-1:2009) | All patient
contacting
materials of
MICRO-NX
Handpiece have
been tested per the
same standards of
ISO 10993-1.
Given the
favorable
biocompatibility
test results, the
differences in
patient contacting
materials do not
raise different
questions in terms
of safety and
effectiveness. |
| Indirect
patient-
contacting
portions of
the device
(water / air
lines) | All materials for
MICRO-NX Dental
Handpiece models are
listed in the tables
below including
chemical composition
of the waterlines and
the patient-contacting
portions of the
device.
Biocompatible
according to ISO
10993-1 (Biological
evaluation of medical
devices - Part 1:
Evaluation and
testing within a risk
management system -
ISO 10993-1:2009) | All materials for
the SMARTmatic
models are listed
in the tables below
including chemical
composition of the
waterlines and the
patient-contacting
portions of the
device.
Biocompatible
according to ISO
10993-1
(Biological
evaluation of
medical devices -
Part 1: Evaluation
and testing within
a risk management
system - ISO
10993-1:2009) | Biocompatible
according to ISO
10993-1
(Biological
evaluation of
medical devices -
Part 1: Evaluation
and testing within
a risk management
system - ISO
10993-1:2009) | All in-direct
patient contacting
materials of
MICRO-NX
Handpiece have
been tested per the
same standards of
ISO 10993-1.
Given the
favorable
biocompatibility
test results, the
differences in
patient contacting
materials do not
raise different
questions of safety
and effectiveness. |
| | | system - ISO
10993-1:2009) | | |
| Chuck
Design | Push Button, Latch
Type | Push Button,
Twist-tension
Chuck, Snap-on &
Screw-in | Push Button, Latch
Type | The chuck design
of MICRO-NX
Dental Handpiece
is the same as the
predicate,
ANTHOGYR
(K093894). |
| Speed Range
(RPM's) | Up to 40,000 rpm | Up to 40,000 rpm | Up to 40,000 rpm | Same Speed
Range |
| Conformance
Standards
(Handpieces
and Motors) | ISO 14457 (Dentistry - Handpieces and
motors - ISO
14457:2012) | ISO 14457
(Dentistry -
Handpieces and
motors - ISO
14457:2012) | ISO 14457
(Dentistry -
Handpieces and
motors - ISO
14457:2012) | Compliant with
the same standards
for dentistry
handpiece and
motors. |
| Conformance
Standards
(Shanks) | ISO 1797 (2017)
"Dentistry - Shanks
for rotary and
oscillating
instruments" | ISO 1797-1 (2011)
"Dentistry -
Shanks for rotary
instruments - Part
1: Shanks made of
metals" | ISO1797-1(1995)
"Dental rotatory
instruments -
Shanks - Par 1:
Shanks
made of metal" | Compliant with
the same standards
of dentistry
shanks. |
| Conformance
Standards
(Coupling
Dimensions) | ISO 3964 (Dentistry -
Coupling dimensions
for handpiece
connectors - ISO
3964:1982) | ISO 3964
(Dentistry -
Coupling
dimensions for
handpiece
connectors - ISO
3964:1982) | ISO 3964
(Dentistry -
Coupling
dimensions for
handpiece
connectors - ISO
3964:1982) | Compliant with
the same standards
of dentistry
coupling
dimensions. |
| Sterilization | Sterilisable according
to ISO 17665-1
(Sterilization of
health care products -
Moist heat - Part 1:
Requirements for the
development,
validation and routine
control of a
sterilization process
for medical devices | Sterilisable
according to ISO
17665-1
(Sterilization of
health care
products - Moist
heat - Part 1:
Requirements for
the development,
validation and
routine control of a | Sterilisable
according to ISO
17665-1
(Sterilization of
health care
products - Moist
heat - Part 1:
Requirements for
the development,
validation and
routine control of a | Conform to the
same standards for
user sterilization. |
| | on the final, finished device - ISO 176651:2006) | sterilization process for medical devices on the final, finished device - ISO 176651:2006) | sterilization process for medical devices on the final, finished device - ISO 176651:2006) | |
| Air / water ports | Internal/ External Spray | No Spray / External Spray | External Spray | Internal spray function added to provide an additional option to the users. Given the favorable test results of the internal spray components, the addition does not raise different questions of safety and effectiveness. |
| Gear Ratio | 20:1/ 1:1 | 8:1/32:1/1:1 | 20:1 | Compared to the predicate device of SMARTmatic device, the addition of a gear ratio of 20:1 does not raise different questions of safety and effectiveness given the favorable test results of performance testing of MICRO-NX Dental Handpiece. |
Table VI-1. Substantial Equivalence Assessment between MICRO-NX Dental Handpiece and Predicate Devices
9
10
11
12
Overall, design verification testing was performed to assess the following critical elements of medical devices used in dentistry applications. The favorable test results of the proposed device which confirmed to meet the FDA recognized standards as well as ISO standard demonstrate Dental Handpiece retains the substantially equivalent profile as the predicate devices of SMARTmatic (K163239) and ANTHOGYR Contra angles and Handpieces (K093894).
- ISO 3964 (2016) "Dental Handpieces – Coupling dimensions" (Recognition List Number: 003 Effective Date: 05/03/1999)
- ISO 14457 (2017)"Dentistry Handpieces and motors" (Recognition List Number: 031 . Effective Date: 09/15/2012)
- ISO 1797 (2017) "Dentistry Shanks for rotary and oscillating instruments" ●
13
VII. DESIGN VERIFICATION & PERFORMANCE DATA
The following design verification and performance data are provided in support of the conclusive determination that the proposed dental handpiece is substantially equivalent to the predicate devices of SMARTmatic (K163239), ANTHOGYR Contra angles and Handpieces (K093894).
Biocompatibility Testing
In accordance with ISO 10993-1: 2009, Biological evaluation of medical devices-Part 1: Evaluation and testing within a risk management process, the proposed Dental Handpiece is categorized as a device appropriate for biocompatibility testing required for devices with Tissue/bone/dentin contact with limited