(151 days)
Not Found
No
The description focuses on mechanical and electrical components for transmitting rotational force and does not mention any computational or data-driven features indicative of AI/ML. The "Mentions AI, DNN, or ML" section is explicitly marked as "Not Found".
Yes
This device is intended for clinical use by dental professionals to perform various dental treatments, including the removal of carious material and tooth preparation, which are therapeutic interventions.
No
The "Intended Use" section describes the device's function as removing material, preparing teeth, and finishing dental work, which are all therapeutic actions, not diagnostic ones. There is no mention of the device identifying diseases or conditions.
No
The device description explicitly details physical components like a main body, gears, and a joint part, indicating it is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use describes the device as being used for mechanical procedures on teeth (removing material, preparing cavities, etc.). This is a direct intervention on the patient's body.
- Device Description: The description details a mechanical device that transmits rotational force for dental treatments. It does not mention any components or processes related to analyzing biological samples (blood, urine, tissue, etc.) outside of the body.
- Lack of IVD Characteristics: There is no mention of analyzing samples, detecting biomarkers, or providing diagnostic information based on in vitro testing.
IVD devices are specifically designed 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
The Dental Handpiece with models of CA160, and CA500L are intended for the removal of carious material, reducing of hard tooth structure, cavity and crown preparations, removal of fillings, processing and finishing tooth preparations, and restorations for polishing teeth.
The 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)
EGS
Device Description
Dental Handpiece with the model CA160, CA160L and CA500L consists of the main body of the handpiece, which is used for transmitting rotational force for the general dental treatments. The torque transmitted from a wired 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 which is transmitted to the head of the dental handpiece. The rotational force is transmitted under the permitted rotation mechanism.
All components of the Model CA160, CA160L and CA500L are the same as the predicate model CA100L and CA100R (K192809) with containing the main body and spray adapter. Model CA160, CA160L and CA500L can be connected to spray adapter (accessory component) which is used for channeling water and air for further applications to the dental treatments. The only difference between model CA160 and CA160L is that the CA160L has lighting function.
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
a 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 testing was performed to assess the product, confirming adherence to FDA recognized standards and ISO standards. The tests conducted were:
- ISO MEM Elution Using L-929 Mouse Fibroblast Cells (GLP)
- ISO Guinea Pig Maximization Sensitization Test (GLP 2 Extracts)
- ISO Intracutaneous Irritation Test (GLP 2 Extracts)
- ISO Materials Mediated Rabbit Pyrogen (GLP)
- ISO Acute Systemic Injection Test (GLP 2 Extracts)
- Appearance Test Operation Test
- Rotational Speed Test
- Noise Test
- Spray Test
- Light Test
- Serviceable Year/ Shelf-Life Test
Key results: The favorable results of the design verification testing demonstrate the design output of Dental Handpice conform to the applicable, pre-determined design requirements of the Dental Handpiece. The testing results also further demonstrate the proposed Dental Handpiece models are substantially equivate device (K192809), as the proposed and predicate device are subject to the same applicable test standards of design requirements for dental handpiece.
Therefore, the identified differences in terms of the dimensions and outer appearance between the proposed Dental Handpiece models CA160, CA160L, and CA500L and the predicate (K192809) CA100L and CA100R do not raise different questions in safety and effectiveness compared to the predicate device Dental Handpiece (K192809).
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 contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health and 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 blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
July 29, 2022
Micro-NX Co., Ltd. % Seohee Kwon RA Manager K-Bio Solutions 201 South 4th Street, Suite 727 San Jose. California 95112
Re: K220577
Trade/Device Name: Dental Handpiece, Model CA160, CA160L, and CA500L Regulation Number: 21 CFR 872.4200 Regulation Name: Dental Handpiece And Accessories Regulatory Class: Class I, reserved Product Code: EGS Dated: May 10, 2022 Received: May 17, 2022
Dear Seohee Kwon:
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.
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
1
statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about 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,
Michael E. Adjodha, M.ChE. Assistant Director DHT1B: Division of Dental and ENT 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) K220577
Device Name Dental Handpiece
Indications for Use (Describe)
The Dental Handpiece with models of CA160, and CA500L are intended for the removal of carious material, reducing of hard tooth structure, cavity and crown preparations, removal of fillings, processing and finishing tooth preparations, and restorations for polishing teeth.
The 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) | |
|---|---|
| ☒ Prescription Use (Part 21 CFR 801 Subpart D) | ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
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510(k) SUMMARY K220577
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 with models of CA160, CA160L, and CA500L.
I. SUBMITTER
510(k) Correspondent: Seohee Kwon RA Specialist, K-Bio Solutions (seohee.kwon(@kbiotechsolutions.com) Tel: 82-2-597-2700
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
Manufacturer Contact: Sojeong Park (sojeong(@micronx.co.kr) Date Prepared: May 10th, 2022
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: EGS ●
- Review Panel: Dental ●
- Regulatory Class: Class I ●
- Traditional 510(k) Registration .
Prior formal correspondence with the FDA resulted in the 510(k) clearance of the Micro-NX Dental Handpiece(K192809) with models of SG200, SG200L, SA100L, SA100R, CA100L, and CA100R.
III. PREDICATE DEVICES
- Predicate Device: Dental Handpiece (K192809), Manufacturer: Micro-NX Co., Ltd.
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IV. DEVICE DESCRIPTION
The intended use of the Dental Handpiece with models of CA160L, and CA500L are the same as the intended use of the predicate (K192809), model CA 100L and CA100R.
- Dental Handpiece with models of CA160, CA160L, and CA500L 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. Dental Handpiece is designed for use by a trained professional in the field of general dentistry.
- Predicate Dental Handpiece (K192809) with models of 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, restorations, and for polishing teeth. Dental Handpiece is designed for use by a trained professional in the field of general dentistry.
Dental Handpiece with the model CA160, CA160L and CA500L consists of the main body of the handpiece, which is used for transmitting rotational force for the general dental treatments. The torque transmitted from a wired 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 which is transmitted to the head of the dental handpiece. The rotational force is transmitted under the permitted rotation mechanism.
Model CA160, CA160L and CA500L
All components of the Model CA160, CA160L and CA500L are the same as the predicate model CA100L and CA100R (K192809) with containing the main body and spray adapter. Model CA160, CA160L and CA500L can be connected to spray adapter (accessory component) which is used for channeling water and air for further applications to the dental treatments. The only difference between model CA160 and CA160L is that the CA160L has lighting function.
The component allocations of the proposed models of Dental Handpiece are provided in Table IV-1 below.
| Table IV-1 Proposed device Model and Component Specificat | |||
|---|---|---|---|
| Model | CA160 | CA160L | CA500L |
| Main Body | X | X | X |
| Spray Adapter | X | X | X |
Table IV-1 Proposed device Model and Component Specification
The four product codes and models of Dental Handpiece are CA160, CA160L, and CA500L. The component names and functional descriptions for critical components of Dental Handpiece are provided in Table IV-2below.
Table IV-2. Component Names and Functional Descriptions for Critical Components of Dental Handpiece: CA160, CA160L, CA500L
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| Component Name | Function | |
|---|---|---|
| Components of Handpiece Model CA500L | ||
| Spindle Assembly | Receives torque from Middle Gear Assembly and transmits torque to final dental bur | |
| Middle Gear Assembly | Transmitting the rotational force from the Inner Handle Assembly and delivers 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 Spindle Assembly. Head Cap is assembled with Button Assembly and Middle Gear Assembly | |
| Head Assembly | The component that is assembled Spindle Assembly, Middle Gear Assembly, Button Assembly, Head Assembly | |
| Joint Gear Assembly | Transmits the torque received from the motor to the Head Assembly | |
| Inner Handle | Case to fix Joint 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 | |
| Angle Handle A | The case of Middle Bevel Gear, Optic, Irrigation Pipe | |
| Angle Handle Assembly | The case of Joint Gear Assembly, Optic, Head | |
| Component Name | Function | |
| Common Components of Handpiece Model CA160 and CA160L | ||
| Spindle Assembly | Receives torque from Middle Gear Assembly and transmits torque to final dental bur | |
| Middle Gear Assembly | Transmitting the rotational force from the Inner Handle Assembly and delivers 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 Spindle Assembly. Head Cap is assembled with Button Assembly and Middle Gear Assembly | |
| Head Assembly | The component that is assembled Spindle Assembly, Middle Gear Assembly, Button Assembly, Head Assembly | |
| Gear Box | ||
| Assembly | It consists of several gears and decelerates. | |
| Joint Gear | ||
| Assembly | Transmits the torque received from the motor to the Head Assembly | |
| Inner Handle | Case to fix Joint Assembly | |
| Locking | ||
| Handle | Head assembly's attachment and detachment. | |
| Angle Handle | ||
| Assembly | The case of Joint Gear Assembly, Optic, Head | |
| Components only Available for Handpiece Model CA160 | ||
| Angle Body | The case is installed in Handle Assembly | |
| Components only Available for Handpiece Model CA160L | ||
| Optic | Optical fiber that allows light to pass from the motor's LED light source to | |
| the handpiece head | ||
| Angle Body | The case is installed in Handle Assembly and protect the optics. |
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V. INDICATIONS FOR USE/INTENDED USE
Dental Handpiece with models of CA160, and CA500L 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.
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 models CA160, and CA500L are substantially equivalent to the predicate device, MICRO-NX Dental Handpiece(K192809) as demonstrated in Table VI-1 belov.
| Proposed Device: | Predicate Device: | Substantial Equivalence Assessments | |
|---|---|---|---|
| Dental Handpiece with models | |||
| CA160, CA160L, and | |||
| CA500L | Dental Handpiece (MICRO- | ||
| NX, K192809) | |||
| 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 restorations for polishing | |||
| teeth. |
In addition, Dental Handpiece
with models of SG200,
SG200L are also intended for | Intended use and indications for
use are the same between Dental
Handpiece with models of
CA160, CA160L, and CA500L
and the predicate device Dental
Handpiece (MICRO-NX,
K192809) for the removal of
carious material, reducing of har
tooth structure, cavity and crowr
preparations, root canal
preparations, removal of fillings,
processing and finishing tooth
preparations, and restorations for
polishing teeth. Dental Handpiec
is designed for use by a trained
professional in the field of gener
dentistry. | |
| Dental Handpiece with models
of CA160, CA160L, and
CA500L 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.
Dental Handpiece is designed
for use by a trained
professional in the field of
general dentistry. | | | |
| | | 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. | Compared to the proposed Dental
Handpiece models of CA160,
CA160L, and CA500L, the
intended use/indications for use of
the predicate for SG200 and
SG200L model (K192809) have
additional intended
use/indications for use for implant
surgery such as perforating the
bone, tapping and threading
procedures. This particular,
additional indications are not
applicable to the proposed Dental
Handpiece models of CA160,
CA160L, and CA500L.
The predicate (K192809) models
of SG200 and SG200L are not
subject of the substantial
equivalence comparison with the
proposed Dental Handpiece. Only
the predicate models of CA100L
and CA100R (K192809), which
do not contain the additional
intended use/indications for use
are subject for substantial
equivalence comparison with the
proposed Dental Handpiece
models CA160, CA160L, and
CA500L. |
| Functional
Principle | Dental Handpiece with models
of CA160, CA160L, CA500L:
Through the micro motor
connected to the dental | Through the micro motor
connected to the dental
treatment unit, the straight and
contra-angle handpieces | Similar Functional Principle |
| | treatment unit, the 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. | 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. | |
| Dimensions | CA160, CA160L, CA500L
Head size-Length: Up to
15mm
Head size-Diameter: Up to
9mm
Length: Up to 95mm | Head size-Length: Up to
14mm
Head size-Diameter: Up to
9mm
Length: Up to 95.80mm | The head size, height, and
diameter of Dental Handpiece are
broadly in alignment with the
dimensions of the predicate,
Dental Handpiece (MICRO-NX,
K192809). The minute differences
in the identified dimensions do
not raise different questions in
terms of safety and effectiveness. |
| Direct patient-
contacting
portions of the
device | All materials for Dental
Handpiece models are listed in
the raw material table above
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 Dental
Handpiece models are listed in
the raw material table above
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) | The proposed Dental Handpiece
models CA160, CA160L, and
CA500L are additional models to
the predicate device of Dental
Handpiece (MICRO-NX,
K192809) and have identical
patient contacting materials to the
predicate device. Therefore,
predicate device biocompatibility
test result per the standards of ISO
10993-1 is applicable to the
models of the proposed device. |
| Indirect
patient- contacting
portions of the
device (water /
air lines) | All materials for Dental
Handpiece models are listed in
the tables above 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 Dental
Handpiece models are listed in
the tables above 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) | The proposed Dental Handpiece
models CA160, CA160L, and
CA500L are additional models to
the predicate device of Dental
Handpiece (MICRO-NX,
K192809) and have identical in- direct patient contacting materials
to the predicate device.
Therefore, predicate device
biocompatibility test result per the
standards of ISO 10993-1 is
applicable to the models of the
proposed device. |
| Chuck Design | Push Button | Push Button, Latch Type | Same,
Chuck design of the proposed
Dental Handpiece is push button
type, whereas the predicate
device(K192809) has additional
chuck design type of latch type. |
| Motor Speed
Range
(RPM's) | Up to 40,000 rpm | Up to 40,000 rpm | Similar 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) | 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 (2017) “Dentistry -
Shanks for rotary and
oscillating instruments” | 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) | Compliant with the same
standards of
ISO 3964 (Dentistry - Coupling
dimensions for handpiece
connectors - ISO 3964:1982) |
| Sterilization | Sterilizable 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 on the final,
finished device - ISO
176651:2006) | Sterilizable 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 on the final,
finished device - ISO
176651:2006) | Conform to the same standards
for user sterilization. |
| Air / water
ports | Internal Spray | Internal/ External Spray | Same,
Compared to the predicate
device(K192809) which consists
of internal and external spray
components, the proposed Dental
Handpiece only consists of
internal spray. |
| Gear
Ratio | CA160, CA160L: 16:1
CA500L: 1:5 | 20:1/ 1:1 | Compared to the predicate device
of Dental Handpiece (MICRO-
NX, K192809), the addition of a
gear ratio of 1:5 and 16:1 does not
raise different questions in terms
of safety and effectiveness given
the favorable test results of
performance testing of Dental
Handpiece. |
Table VI-1. Substantial Equivalence Assessment between MICRO-NX Dental Handpiece and Predicate Device(K192809)
8
9
10
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Overall, Design verification testing were performed to assess the following critical 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
12
standard demonstrate Dental Handpiece retains the substantially equivalent profile in safety and essential performance of medical electrical equipment as the predicate device Dental Handpiece (MICRO-NX, K192809).
- · 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 instrument
VII. DESIGN VERIFICATION & PERFORMANCE DATA
The following design vertification and performance data are provided in support of the conclusive determination that the proposed dental handpiece is substantially equivalent to the predicate device Dental Handpiece (MICRO-NX, K 1192809).
Biocompatibility Testing
The biocompatibility testing conducted for the predicate device (K192809) is applicable to the proposed Dental Handpiece models CA160, CA160L. The proposed Dental Handpiece models CA160, CA160L, and CA500L are additional models to the predicate device Dental Handpiece (K192809). All of the patient-contacting raw materials of the proposed Dental Handpiece models are the predicate device Dental Handpiece (K192809) with no new introduction of patient contacting raw materials for the proposed Dental Handpiece models.
In accordance with ISO 10993-1: 2009, Biological evaluation of medical devices-Part 1: Evaluation and testing within a risk management process, the Dental Handpiece models CA160L, and CA500L is classified as "Externally Communicating Device-Tissue/dentin (Limited contact duration). This is the same classification of the biocompatibility evaluation as the predicate Dental Handpiece (K192809).
The biocompatibility testing of the Dental Handpiece listed below has been conducted in 2019 in order to ensure FDA's latest consensus standards with respect to biocompatibility evaluations are met for the favorable biocompatibility test results drawn in 2019 testing confirms the biocompatibility profile of the Dental Handpiece.
- ISO MEM Elution Using L-929 Mouse Fibroblast Cells (GLP) .
- ISO Guinea Pig Maximization Sensitization Test (GLP 2 Extracts) ●
- ISO Intracutaneous Irritation Test (GLP 2 Extracts) ●
- ISO Materials Mediated Rabbit Pyrogen (GLP) .
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- ISO Acute Systemic Injection Test (GLP 2 Extracts) .
Design Verification and Validation Testing
The proposed, Micro-NX Dental Handpiece models CA160L, and CA500L have been evaluated and risk management practice has been implemented in accordance with ISO 14971 Medical devices - applications of risk management to medical devices.
- Appearance Test .
- Operation Test .
- Rotational Speed Test ●
- Noise Test ●
- Spray Test ●
- Light Test .
- Serviceable Year/ Shelf-Life Test ●
The favorable results of the design verification testing demonstrate the design output of Dental Handpice conform to the applicable, pre-determined design requirements of the Dental Handpiece. The testing results also further demonstrate the proposed Dental Handpiece models are substantially equivate device (K192809), as the proposed and predicate device are subject to the same applicable test standards of design requirements for dental handpiece.
Therefore, the identified differences in terms of the dimensions and outer appearance between the proposed Dental Handpiece models CA160, CA160L, and CA500L and the predicate (K192809) CA100L and CA100R do not raise different questions in safety and effectiveness compared to the predicate device Dental Handpiece (K192809).
VIII. CONCLUSIONS
Overall, the proposed device is comparable to the predicate device given the fact that its indications for use are the same, and fundamental technological characteristics are equivalent to those of the predicate device Dental Handpiece (MICRO-NX, K192809). The favorable results of the aforementioned design verfication and performance to the appropriate standards perinent to dental handpieces, and demonstrate that no different questions of safety and effectiveness assessment are being raised compared to the predicate device of Dental Handpiece (MICRO-NX, K192809).
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