(699 days)
No
The device description and performance studies focus on mechanical and biocompatibility testing, with no mention of AI/ML capabilities or data processing.
Yes
The device is described as a "tool for patients with tooth disease" and its intended uses include "removing carious material, excess filling material, cavity and crown preparation," which are all therapeutic interventions for dental conditions.
No
The device is a dental handpiece used for drilling, grinding, and repairing teeth, which are therapeutic functions, not diagnostic ones.
No
The device description explicitly states it is composed of physical components like a handpiece and connector, and is used for physical actions like drilling and grinding. There is no mention of software as the primary or sole component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes the device as being used for mechanical procedures on teeth (removing material, preparing cavities, polishing, etc.). These are physical manipulations of the tooth structure, not diagnostic tests performed on biological samples.
- Device Description: The description reinforces that it's a tool for drilling, grinding, and repairing teeth.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, tissue, etc.), detecting analytes, or providing diagnostic information about a patient's health condition.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for diagnosis, monitoring, or screening. This dental handpiece does not fit that description.
N/A
Intended Use / Indications for Use
Dental High-speed Turbine Handpiece (WJ-114, WJ-122, WJ-124, WJ-134, WJ-132, WJ-144, WJ -142, WJ -154, WJ -162, WJ -162) is intended for removing carious material, excess filling material, cavity and crown preparation, finishing tooth preparations and restorations, root canal preparations and polishing teeth. Dental Low-speed Turbine Handpiece (WJ-414, WJ-424, WJ-422) is intended for removing carious material, excess filling material, cavity and crown preparations and restorations and restorations, root canal preparations and polishing teeth.
Product codes (comma separated list FDA assigned to the subject device)
EFB, EGS
Device Description
The Dental High-speed Turbine Handpiece is the dental clinic, hospital treatment for patients with tooth disease tools, which is an instrument for drilling, grinding, repairing. It composed of handpiece and a connector, including models WJ-114, WJ-112, WJ-124, WJ-134, WJ-134, WJ -144, WJ -142, WJ -154, WJ -152, WJ -164, WJ -162.
For the model name which including: WJ represent for branch name.
WJ-1XX represent for Dental High-speed Turbine Handpiece;
WJ-XX2 represent for model which included 2-hole (drive air and water holes);
WJ-XX4 represent for model which included 4-hole coupling (drive air, exhaust air, spray air and spray water holes);
Handpiece are able to run 300000 to 400000 rpm.
Handpiece and adaptors can bear steam disinfection at 135degC. The scope of application: for dental professional use only.
Lubricant should be used during routine maintenance (e.g. after each patient use and prior to sterilization).
In order to avoid the risk, user must buy and use specified lubricant type "PANA SPRAY Plus" manufactured by NAKANISHI INC (cleared in K163483).
The Dental Low-speed Handpiece is the dental clinic, hospital treatment for patients with tooth disease tools, which is an instrument for drilling, grinding, repairing. It composed of handpiece and a connector, including low speed air motor, straight handpiece and geared angle handpiece, for the model WJ-414, WJ-412, WJ-424, WJ-422
The gear ratios of handpieces have a various gear ratio (for different geared angle handpiece) (1:1 (constant), 20:1 (speed reduction) and 1:5 (speed increase));
The handpieces have maximum Forward rotation speed 19000 rpm and maximum Reverse rotation speed of 18000 rpm.
The air motors are capable of running up to a speed of 22000 rpm, but different pressure of air supply.
Handpiece and adaptors can bear steam disinfection at 135degC. Coupling is the accessory for handpiece to connect with tubes of dental unit. It could be divided into three types. It included 2-hole (drive air and water holes) and 4-hole coupling (drive air, exhaust air, spray air and spray water holes). The use of the coupling of handpiece is due to the number of tubes of dental unit. The scope of application: for dental professional use only.
Lubricant should be used during routine maintenance (e.g. after each patient use and prior to sterilization).
In order to avoid the risk, user must buy and use specified lubricant type "PANA SPRAY Plus" manufactured by NAKANISHI INC (cleared in K163483).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Tooth
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Dental professional use only, dental clinic, hospital
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)
Performance testing was provided including:
- Cytotoxicity, sensitization, and irritation biocompatibility test according to ISO 10993-5 and ISO 10993-10 standards
- Performance test according to ISO 14457:2012 standards.
- Medical electrical equipment test according to IEC 60601-2-60 standards
- Sterilization and cleaning validation per ISO 17665-1, ISO 17665-2, ASTM ST79, and the FDA Guidance Document "Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling"
The result of tests indicates that the Dental Handpiece and Accessories has substantial equivalent performance as the legally marketed predicate device.
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.
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). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
May 26, 2020
Foshan Wenjian Medical Instrument Co., Ltd. % Cassie Lee Manager Guangzhou GLOMED Biological Technology Co., Ltd. Suite 306, Kecheng Mansion, No.121 Science Road, Guangzhou Science Park Guangzhou, Guangdong, 510663 CHINA
Re: K181691
Trade/Device Name: High-speed air turbine handpiece / Low-speed air turbine handpiece Regulation Number: 21 CFR 872.4200 Regulation Name: Dental Handpiece and Accessories Regulatory Class: Class I, reserved Product Code: EFB, EGS Dated: April 9, 2020 Received: April 27, 2020
Dear Cassie Lee:
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 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,
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) K181691
Device Name
High-speed air turbine handpiece / Low-speed air turbine handpiece
Indications for Use (Describe)
Dental High-speed Turbine Handpiece (WJ-114, WJ-122, WJ-124, WJ-134, WJ-132, WJ-144, WJ-142, WJ -154, WJ -162, WJ -162) is intended for removing carious material, excess filling material, cavity and crown preparation, finishing tooth preparations and restorations, root canal preparations and polishing teeth. Dental Low-speed Turbine Handpiece (WJ-414, WJ-424, WJ-422) is intended for removing carious material, excess filling material, cavity and crown preparations and restorations and restorations, root canal preparations
and polishing teeth.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| \u2612 Prescription Use (Part 21 CFR 801 Subpart D) | \u2610 Over-The-Counter Use (21 CFR 801 Subpart C) |
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3
K181691
510(k) Summary Date Prepared: May 22, 2020
1. Submitter's Information
Name of Sponsor: Foshan Wenjian Medical Instrument Co., Ltd. Address: Third Floor, No.3, Jiebian Industrial Zone, LuoCun, ShiShan Town, Nanhai, Foshan City, Guangdong, China Contact Name (Title): Wen Huang (Manager) Telephone No.: 86-757-81801258 Email: 1191837402@gqq.com
Application Correspondent:
Contact Person: Ms. Cassie Lee Guangzhou GLOMED Biological Technology Co., Ltd. Address: Suite 306, Kecheng Mansion, No.121 Science Road, Guangzhou Science Park, Guangzhou 510663, China Tel: +86-20-61099984 Email: regulatory@glomed-info.com
2. Subject Device Information:
Common Name: Dental Handpiece and Accessories Trade Name: High-speed air turbine handpiece / Low-speed air turbine handpiece Model: Dental High-speed Turbine Handpiece (WJ-114, WJ-112, WJ-122, WJ-134, WJ-134, WJ -144, WJ -142, WJ -154, WJ -152, WJ -164, WJ -162) Dental Low-speed Turbine Handpiece (WJ-414, WJ-412, WJ-422) Classification Name: Dental Handpiece and Accessories Review Panel: Dental Product Code: EFB, EGS Regulation Class: 1 Regulation Number: 21 CFR 872.4200
3. Predicate Device Information:
Primary Predicate: (K170229)
Company Name: Guangdong JINME Medical Technology Co., Ltd. Common Name: Dental Handpiece and Accessories Trade Name: Dental High-speed Turbine Handpiece Product Code: EFB Regulation Class: 1
Reference Device 1: (K170236)
4
Company Name: Guangdong JINME Medical Technology Co., Ltd. Common Name: Dental Handpiece and Accessories Trade Name: Dental Low-speed Turbine Handpiece Product Code: EFB, EGS Regulation Class: 1
Reference Device 2: (K141886)
Company Name: Modern Korea Co., Ltd. Trade Name: MDK Handpieces Classification Name: Dental Handpiece and Accessories Product Code: EFB Regulation Class: 1
4. Device Description
� Dental High-speed Turbine Handpiece
The Dental High-speed Turbine Handpiece is the dental clinic, hospital treatment for patients with tooth disease tools, which is an instrument for drilling, grinding, repairing. It composed of handpiece and a connector, including models WJ-114, WJ-112, WJ-124, WJ-134, WJ-132, WJ-144, WJ -142, WJ -154, WJ -152, WJ -164, WJ -162.
For the model name which including: WJ represent for branch name.
WJ-1XX represent for Dental High-speed Turbine Handpiece;
WJ-XX2 represent for model which included 2-hole (drive air and water holes);
WJ-XX4 represent for model which included 4-hole coupling (drive air, exhaust air, spray air and spray water holes);
Handpiece are able to run 300000 to 400000 rpm.
Handpiece and adaptors can bear steam disinfection at 135°C. The scope of application: for dental professional use only.
Lubricant should be used during routine maintenance (e.g. after each patient use and prior to sterilization).
In order to avoid the risk, user must buy and use specified lubricant type "PANA SPRAY Plus" manufactured by NAKANISHI INC (cleared in K163483).
� Dental Low-speed Turbine Handpiece
The Dental Low-speed Handpiece is the dental clinic, hospital treatment for patients with tooth disease tools, which is an instrument for drilling, grinding, repairing. It composed of handpiece and a connector, including low speed air motor, straight handpiece and geared angle handpiece, for the model WJ-414, WJ-412, WJ-424, WJ-422
5
The gear ratios of handpieces have a various gear ratio (for different geared angle handpiece) (1:1 (constant), 20:1 (speed reduction) and 1:5 (speed increase));
The handpieces have maximum Forward rotation speed 19000 rpm and maximum Reverse rotation speed of 18000 rpm.
The air motors are capable of running up to a speed of 22000 rpm, but different pressure of air supply.
Handpiece and adaptors can bear steam disinfection at 135°C. Coupling is the accessory for handpiece to connect with tubes of dental unit. It could be divided into three types. It included 2-hole (drive air and water holes) and 4-hole coupling (drive air, exhaust air, spray air and spray water holes). The use of the coupling of handpiece is due to the number of tubes of dental unit. The scope of application: for dental professional use only.
Lubricant should be used during routine maintenance (e.g. after each patient use and prior to sterilization).
In order to avoid the risk, user must buy and use specified lubricant type "PANA SPRAY Plus" manufactured by NAKANISHI INC (cleared in K163483).
5. Intended Use / Indications for Use
Dental High-speed Turbine Handpiece (WJ-112, WJ-124, WJ-122, WJ-134, WJ-132, WJ -144, WJ -142, WJ -154, WJ -152, WJ -164, WJ -162) is intended for removing carious material, excess filling material, cavity and crown preparation, finishing tooth preparations and restorations, root canal preparations and polishing teeth.
Dental Low-speed Turbine Handpiece (WJ-414, WJ-412, WJ-422) is intended for removing carious material, excess filling material, cavity and crown preparation, finishing tooth preparations and restorations, root canal preparations and polishing teeth.
6. Test Summary
High-speed air turbine handpiece / Low-speed air turbine handpiece is designed, tested and will be manufactured in accordance with both mandatory and voluntary standards. Performance testing was provided including:
- Cytotoxicity, sensitization, and irritation biocompatibility test according to ISO 10993-5 and ISO 10993-10 standards
- Performance test according to ISO 14457:2012 standards.
- Medical electrical equipment test according to IEC 60601-2-60 standards
- Sterilization and cleaning validation per ISO 17665-1, ISO 17665-2, ASTM ST79, and the FDA Guidance Document "Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling"
6
The result of tests indicates that the Dental Handpiece and Accessories has substantial equivalent performance as the legally marketed predicate device.
| Elements
of
Comparison | Subject Device | Primary
Predicate | Reference
Device 1 | Reference
Device 2 | Remark |
|----------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------|
| Manufactur
er | Foshan Wenjian
Medical Instrument
Co., Ltd. | Guangdong
JINME Medical
Technology Co.,
Ltd. | Guangdong
JINME Medical
Technology
Co., Ltd. | Modern Korea
Co. Ltd. | -- |
| Device
Name | High-speed air
turbine handpiece /
Low-speed air
turbine handpiece | Dental High-
speed Turbine
Handpiece | Dental Low-
speed Turbine
Handpiece | MDK
Handpieces | -- |
| Model | Dental High-speed
Turbine Handpiece
(WJ-114, WJ- 112,
WJ-124, WJ -122,
WJ-
134, WJ -132, WJ -
144, WJ
-142, WJ -154, WJ -
152,
WJ -164, WJ -162)
Dental Low-speed
Turbine Handpiece
(WJ-414, WJ- 412,
WJ-424, WJ-422) | T, S, M, TU, SU,
MU, TP, SP,
TUQ, TUP, SUP,
SUQ, TUL, SUL,
TUQL, SUQL,
TUQP, SUQP,
45- T,45-TU,45-
TUQ | LN, L | -- | -- |
| 510(k)
Number | K181691 | K170229 | K170236 | K141886 | -- |
| Product
Code | EFB, EGS | EFB | EFB, EGS | EFB | SE |
| Indications
for Use&
Intended
Use | Dental High-speed
Turbine Handpiece
(WJ-114, WJ- 112,
WJ-124, WJ -122,
WJ-
134. WJ -132. WJ -
144, WJ
-142, WJ -154, WJ -
152,
WJ -164, WJ -162) is
intended for
removing carious
material, excess
filling material, cavity
and crown
preparation, finishing
tooth preparations
and restorations, root
canal preparations
and polishing teeth.
Dental Low-speed | Dental High-
speed Turbine
Handpiece is
intended for
removing carious
material, excess
filling material,
cavity and crown
preparation,
finishing tooth
preparations and
restorations, root
canal
preparations and
polishing teeth. | Dental Low-
speed Turbine
Handpiece is
intended for
removing
carious
material, excess
filling material,
cavity and
crown
preparation,
finishing tooth
preparations
and
restorations,
root canal
preparations
and polishing
teeth. | MDK high-
speed
handpieces
are used for
the removal of
carious
material,
reducing of
hard
tooth
structure,
cavity and
crown
preparations,
removal of
fillings,
processing
and finishing
tooth
preparations,
restorations, | SE
Note 1 |
| | | | | | |
| | Turbine Handpiece
(WJ-414, WJ- 412,
WJ-424, WJ-422) is
intended for
removing carious
material, excess
filling material, cavity
and crown
preparation, finishing
tooth preparations
and restorations, root
canal preparations
and polishing teeth. | | | and for
polishing
teeth.
MDK low-
speed
handpieces
used for teeth
cutting, cavity
and crown
preparation,
restorations
and polishing
teeth.
All the devices
are designed
for use by a
trained
professional in
the field of
general
dentistry. | |
| Air/water
ports | 2/4 ports | 2/4 ports | 2/4 ports | Up to four | SE |
| Fiberoptic
Glass Rod | Included in model
WJ-162, WJ-164,
WJ-424 and WJ-
422 | N/A | N/A | Yes (11
models)
No (10
models) | SE
Note 2 |
| Dimensions | Refer to table 1 | N/A | N/A | N/A | SE
Note 3 |
| Accessories | N/A | N/A | N/A | High
-speed
handpieces
Wrench,
Connector (for
inserting
lubricant)
Low-speed
handpieces
Head opener
for the latch
type,
Connector for
inserting
lubricant,
External
Spray Tubing
with nozzle | SE
Note 4 |
| Compositio
n of material | Stainless steel,
Brass, Aluminum,
Titanium | Stainless steel,
Brass.
Aluminum,
Titanium | Stainless Steel,
Brass, Titanium | Stainless steel
and titanium | SE |
| Chuck | Push button, Screw | Push button,
Screw | Push button
Latch-type
chuck | push button,
latch, screw,
snap-on or tip-
lock chuck
options | SE |
| Bur
extraction
force | 28N | 28N | -- | 30N | SE |
| Maximum
air pressure | Dental High-speed
Turbine Handpiece:
200kPa ~ 250kPa
(29.01 psi~ 36.25
psi)
Dental Low-speed
Turbine Handpiece:
245 ~ 392 kPa
(35.53 psi~ 56.85
psi) | 177kPa ~
301kPa (25.67
psi~ 45.66
psi) | 245 ~ 392 kPa
(35.53 psi~
56.85
psi) | 36psi to 43psi | SE
Note 3 |
| Maximum
water
pressure | Dental High-speed
Turbine Handpiece:
200kPa ~ 250kPa
(29.01 psi~ 36.25
psi)
Dental Low-speed
Turbine Handpiece:
245 ~ 392 kPa
(35.53 psi~ 56.85
psi) | | | | |
| Speed in
rpms | Dental High-speed
Turbine Handpiece:
300,000rpm ~
400,000rpm
Dental Low-speed
Turbine Handpiece:
18,000 ~
20,000 rpm | 300,000rpm ~
400,000rpm | 18,000 ~
22,000
rpm | High
-speed
handpieces
320,000 ~
400,000rpm
Low-speed
handpieces
Up to 20,000
rpm | SE
Note 3 |
| Conformanc
e with
standards
for
shanks | Type 3 per ISO
1797-1 | Type 3 per ISO
1797-1 | Type 3 per ISO
1797-1 | N/A | SE |
| Coupling
dimensions | Complied with ISO
3964 | N/A | Complied with
ISO 3964 | N/A | SE |
| Hose
connections | Type 1 for 2-hole
model / Type 2 for 4-
hole model | Type 1 for 2-hole
model / Type 2
for 4- hole model | Type 1 for 2-
hole model /
Type 2 for 4-
hole model | N/A | SE |
| Lubricant | The specified
lubricant, type
"PANA SPRAY Plus"
manufactured by
NAKANISHI INC
(cleared in
K163483), must be
used during routine
maintenance. | The specified
lubricant, type
"PANA SPRAY
Plus"
manufactured by
NAKANISHI INC
(cleared in
K163483), must
be
used during
routine
maintenance. | The specified
lubricant, type
"PANA SPRAY
Plus"
manufactured
by NAKANISHI
INC
(cleared in
K163483), must
be
used during
routine | Pana-Spray
made by
NSK(K052700
) | SE
Note 5 |
| | | | maintenance. | | |
| Compliance
Standards | Complied with ISO
10993-5, ISO
10993-10, IEC
60601-1, IEC 80601-
2-60, ISO14457, ISO
17665, ISO 11138,
ISO 11607, ISO
17664 | Complied with
ISO 10993-5,
ISO 10993-
10, ISO14457 | Complied with
ISO 10993-5,
ISO
10993-10,
ISO14457 | Complied with
ISO 17665,
ISO 11138,
ISO 11135,
ISO
11607,
ISO 17664,
and USP 30-
NF 25,ISO
14457, ISO
10993-5 | SE
Note 6 |
7. Comparison to predicate device and conclusion
7
8
9
Comparison in Detail
Note 1:
Although the subject devices are a little difference from predicate devices in "Intended Used", but it's the combination of predicate devices K170229 and K170236. And it's the same with K141886. So, the difference will not raise any substantial equivalence issue.
Note 2:
Although the subject devices are a little difference from predicate devices in "Fiberoptic" glass rod to transmit light, but the subject devices are compliance with safety standard IEC 60601-1 instead. But it's the same with K141886. So the difference will not raise any substantial equivalence issue.
Note 3:
Although the subject devices are a little difference from predicate devices in "Dimensions", "Maximum air pressure", "Maximum water pressure" and "Speed in rpms", the subject devices are it's the features combination of predicate devices K170229 and K170236 and K141886. So, the difference will not raise any substantial equivalence issue.
Note 4:
The subject devices are a little difference from predicate devices in "Accessories" with K141886, but it's the same with the predicate devices K170229 and K170236. The accessories in predicate devices are mainly tools for cleaning handpieces. Not part of predicate devices. So the accessories do not affect the product performance. So, the difference will not raise any substantial equivalence issue.
Note 5:
The subject devices are a little difference from predicate devices in "Lubricant", but the Lubricant is only used for lubrication. As long as it meets the requirements and is FDA cleared, Lubricant can achieve lubrication.
Therefore, which brand of Lubricant is used does not affect the performance of the device. So, the difference will not raise any substantial equivalence issue.
10
Note 6:
The common sterilization method of dental handpieces is steam sterilization, because the structure and material characteristics of dental handpieces:. The common dental handpieces sterilization method in the market is also steam sterilization. Therefore, ISO 17665 is applicable standard for verification of steam sterilization. The sterilization method adopted by the subject device is the commonly used steam sterilization. Because the sterilization USES steam, there is no other harmful residue after sterilization. Therefore, there is no need to refer to ISO 11135 and USP 30-NF25 for subject device. So, the difference will not raise any substantial equivalence issue.
Finial conclusion:
The subject device Dental High-speed Turbine Handpiece (WJ-114, WJ-124, WJ -122, WJ- 134, WJ -132, WJ -144, WJ -142, WJ -154, WJ -152, WJ -164, WJ -162), Dental Low-speed Turbine
Handpiece (WJ-414, WJ-412, WJ-424, WJ-422) has all features of predicate devices. Thus, the subject device is substantially equivalent to the predicate device.