(168 days)
No
The device description and performance studies focus on mechanical and sterilization aspects, with no mention of AI, ML, or image processing.
No.
A therapeutic device is one that treats or cures a disease or condition. This device is used for cutting and grinding teeth and filling materials, which are preparatory or restorative actions, not therapeutic.
No
The device is described as a general cutting contra handpiece used for cutting and grinding teeth, cavity preparations, and removal of materials, which are surgical/interventional procedures, not diagnostic ones.
No
The device description clearly describes a physical handpiece with mechanical components (motor speed, contra-angle appearance) and mentions connections to motors and compliance with hardware standards (ISO 3964, ISO 14457). Performance studies also focus on bench testing and sterilization validation, which are typical for hardware devices.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a device used for mechanical procedures on teeth (cutting, grinding, preparing, finishing, trimming, and removal). This is a direct intervention on the patient's body.
- Device Description: The description details a handpiece that connects to a motor for physical manipulation.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or screening.
IVD devices are used in vitro (outside the body) to analyze biological samples. This device is used in vivo (inside the body) for direct treatment and manipulation of teeth.
N/A
Intended Use / Indications for Use
The General Cutting Contra Handpiece is powered by either an air-motor or electronic micromotor for use in general dentistry. The device is intended for cutting and grinding teeth, cavity preparations, tooth and crown preparations, finishing and trimming teeth and filling materials and removal of crowns and filling materials.
Product codes (comma separated list FDA assigned to the subject device)
EGS
Device Description
The General Cutting Contra Handpiece features an allowable maximum motor speed at 40,000 min-1 . The handpieces are provided optic and non-optic and are designed with a contra-angle appearance. Models are available to be connected directly onto motors compliant to ISO 3964. Available handpieces include the S-Max M Contra Series, Ti-Max X Contra Series, Ti-Max Z Contra Series and the Ti-Max nano Series.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
teeth
Indicated Patient Age Range
Not Found
Intended User / Care Setting
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)
The General Cutting Contra Handpiece was developed and is produced under considerations of all applicable technical standards, internal specifications, and FDA guidance documents. The product's conformance with applicable international and internal standards was verified in the course of bench testing. Tests were performed on the handpiece including verification/validation testing to internal functional specifications which demonstrated that the device is substantially equivalent and complies with FDA requirements stated in Guidance Document "Dental Handpieces - Premarket Notification [510(k)] Submissions - Guidance for Industry and FDA Staff'. Sterilization has been validated in conformance to the FDA recognized consensus standard AAMI/ANSI/ISO 17665-1:2006; "Sterilization of Health Care Products – Moist Heat - Part 1: Requirements for the Development, Validation, and Routine Control of a Sterilization Process for Medical Devices." Documentation was provided demonstrating that the General Cutting Contra Handpiece complies with the FDA requirements stated in Guidance for the "Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling - Guidance for Industry and Food and Drug Administration Staff". Biocompatibility evaluations were selected in accordance with AAMI/ANSI/ISO 10993-1: "Biological evaluation of medical devices - Part 1: Evaluation and testing" and FDA Guidance "Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process- Guidance for Industry and Food and Drug Administration Staff". In addition, testing for electrical safety was performed in accordance with ISO 14457.
NAKANISHI, INC. considers the General Cutting Contra Handpiece to be Conclusion substantially equivalent to the predicate devices listed above. This conclusion is based on the similarities in primary intended use, principles of operation, functional design, and established medical use.
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
| Submitter | NAKANISHI INC.
700 Shimohinata
Kanuma-Shi, Tochigi-Ken Japan 322-8666 | | |
|------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------|-----------------------------------------------|
| Contact
Person | Mr. Kimihiko Satoh
General Manager, Regulatory Affairs, R&D Division
TEL: +81-289-64-3380
FAX: +81-289-62-6665
k-satoh@nsk-nakanishi.co.jp | | |
| Date Prepared | April 15, 2019 | | |
| Trade Name | General Cutting Contra Handpiece | | |
| Common
Name | Handpiece, Contra-And Right-Angle Attachment, Dental | | |
| Classification
Name | Dental Handpiece and Accessories | | |
| Product Code | EGS | Class I | 872.4200 |
| Predicate
Device | K972569 | NAKANISHI INC. | E-Type Speed Increaser
Contra Angle, ES-95 |
| Reference
Devices | K113655 | NAKANISHI, INC. | Ti-Max X Turbine |
| | K073652 | NAKAMURA | ND LOWSPEED
AIRMOTOR |
| Device
Description | The General Cutting Contra Handpiece features an allowable maximum motor
speed at $40,000 min^{-1}$ . The handpieces are provided optic and non-optic and are
designed with a contra-angle appearance. Models are available to be connected
directly onto motors compliant to ISO 3964. Available handpieces include the
S-Max M Contra Series, Ti-Max X Contra Series, Ti-Max Z Contra Series and
the Ti-Max nano Series. | | |
| Indications for
Use | The General Cutting Contra Handpiece is powered by either an air-motor or
electronic micromotor for use in general dentistry. The device is intended for
cutting and grinding teeth, cavity preparations, tooth and crown preparations,
finishing and trimming teeth and filling materials and removal of crowns and
filling materials. | | |
| Summary of
Technological
Characteristics | As with the predicate devices referenced above, the General Cutting Contra
Handpiece is intended for dental treatment. The handpieces are powered by
either an air-motor or electronic micro motors compliant to ISO 14457 with
couplings compliant to [ISO 3964 (EN ISO 3964)]. Friction Grip Burs and
Contra Angle Burs that conform to ISO 1797-1 (EN ISO 1797) are to be used
with the General Cutting Contra Handpiece. The allowable maximum motor
speed rotation for the handpieces is at $40,000 min^{-1}$ . The handpieces are available | | |
Image /page/0/Picture/2 description: In the image, a hand wearing a white glove is holding a blue plastic tool. The tool has a unique design with sharp edges and points. The words "Powerful Partners" are written at the bottom of the image. The hand is holding the tool in a way that suggests it is being used for a precise task.
1
with fiber optic and non-optic. All models include a water spray feature. The General Cutting Contra Handpiece is provided non-sterile, so it must be sterilized prior to first use and sterilized after each subsequent use using steam sterilization (moist heat sterilization).
The proposed device shares technological characteristics with the predicate device. The proposed device also has some differences in technological characteristics from those of the predicate device. Any differences in the technological characteristics are minor and reflect market strategy and/or perceived user preferences.
| | Proposed Device:
NAKANISHI INC.
[K182999] | Predicate Device:
NAKANISHI INC.
[K972569] | Reference Device:
NAKANISHI INC.
[K113655] | Reference Device:
NAKAMURA
DENTAL
[K073652] | Coupling
Type | ISO 3964 (EN ISO
3964) Standard
Coupling | ISO 3964 Standard
Coupling | Nakanishi (NSK),
KaVo, W&H, Bien
Air, Sirona | ISO 3964 Standard
Coupling |
|---------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------|
| Trade
Name | General Cutting
Contra Handpiece | E-Type Speed
Increaser Contra
Angle, ES-95 | Ti-Max X Turbine
Series | ND E-TYPE
CONTRAANGLE | Burs | ISO 1797-1 (Type1)
ISO 1797-1 (Type3) | ISO-1797-1 (Type
3)
(1.6mm
or .0630in) | ISO 1797-1 Type 3 | EC-20L : ISO 1797-1
(Type1)
EC-30BL: ISO 1797-1
(Type1)
EG-20L : ISO 1797-1
(Type1)
EGG-20L:Unknown |
| Model
Numbers | S-Max M:
M15L, M15, M25L,
M25, M95L, M95
Ti-Max X:
X10L, X10, X12L,
X12, X15L, X15,
X20L, X20, X25L,
X25, X85, X85L, X95,
X95L
Ti-Max Z:
Z10L, Z15L, Z25L,
Z85L, Z95L
Ti-Max nano:
nano15LS, nano25LS,
nano95LS | ES-95 | Miniature Head:
X500; X500L;
X500K; X500KL;
X500SL; X500WL;
X500BL
Standard Head:
X600; X600L;
X600K; X600KL;
X650L; X650KL;
X600SL; X600WL;
X600BL;
X600WLED;
X600BLED
Torque Head:
X700; X700L;
X700K : X700KL:
X700SL; X700WL;
X700BL; | EC-20L
EC-30BL
EG-20L
EGG-20L | Max
Rotation
Speed
(motor) | $40,000min^{-1}$ max | $40,000min^{-1}$ max | Miniature Head:
(500): 390,000 –
450,000
Standard Head:
(600): 380,000 –
440,000
Torque Head:
(700): 300,000 –
360,000 | EC-20L : $20,000min^{-1}$
EC-
30BL : $30,000min^{-1}$
EG-20L : $20,000min^{-1}$
EGG-20L:Unknown |
| Indication
for Use | The General Cutting
Contra Handpiece is
powered by either an
air-motor or electronic
micromotor for use in
general dentistry. The
device is intended for
cutting and grinding
teeth,
cavity
preparations, tooth and
crown preparations,
finishing and trimming
teeth and filling
materials and removal
of crowns and filling
materials. | The device is
intended for use
where high speed
such as 200,000 rpm
is required in general
dentistry with or
without use of
coolant; such as
cutting a tooth for
cavity and/or crown
preparation and
finishing, cutting
and/or finishing of
dentures, denture
bases, crowns, inlays
and metal plates.
The device is driven
by an electrical
micrometer or an air
motor handpiece that
has the ISO-3964
coupling. | The Ti-Max X Series
is an air-powered
dental handpiece
intended for removing
carious material,
reducing hard tooth
structure, cavity
preparation, finishing
tooth preparations and
restorations and
polishing teeth. | ND e-type contra p is
powered by either low
speed air-motor or
electric micromotor
for removing carious
material and excess
filling material, cavity
and crown
preparation, root | Gear Ratio
Max
rotation
speed
(handpiece) | 16:1 Reduction-
$2,500min^{-1}$
10:1 Reduction-
$4,000min^{-1}$
4:1 Reduction-
$10,000min^{-1}$
1:1 Direct Drive-
$40,000min^{-1}$
1:5 Increasing-
$200,000min^{-1}$ | 1:5 Increasing-
$200,000min^{-1}$ | N/A | 16:1 Reduction:
Unknown
4:1 Reduction:
$5,000min^{-1}$
1:1 Direct Drive:
$30,000min^{-1}$ |
| Weight | 53.5g - 78.5g | 62.5 g | 36.7 – 52.5g | Unknown | Cleaners/
Lubricants | NSK PANA SPRAY
Plus (K163483) | Mineral Oil | Care3 Plus automatic
handpiece
cleaning/lubrication
tabletop unit
[K081811] | YOSHIDA
Lubrication Oil Spray |
| Sterilization
Method | Steam Autoclave
(Moist Heat) | Steam Autoclave
(Moist Heat) | Steam Autoclave
(Moist Heat) | Steam Autoclave
(Moist Heat) | | | | | |
| Sterilization
Standard | ANSI/AAMI/ISO
17665-1:2006 | ISO 17665-1 | EN ISO 17665-
1:2006 | Unknown | | | | | |
Image /page/1/Picture/4 description: The image shows a hand wearing a white glove holding a blue object with the text "Powerful Partners" below. The blue object appears to be a stylized logo or design element. The hand is positioned in a way that suggests it is presenting or showcasing the blue object. The background is plain, drawing attention to the hand and the blue object.
NAKANISHI INC. Headquarters : 700 Shimohihata Kanuma-shi Tochigi 322-8666, Japan www.nsk-inc.com Tokyo Office : MY Building 1-13-3 Ueno Taito-ku Tokyo 110-0005, Japan
2
NSK
Summary of Performance Testing
The General Cutting Contra Handpiece was developed and is produced under considerations of all applicable technical standards, internal specifications, and FDA guidance documents. The product's conformance with applicable international and internal standards was verified in the course of bench testing. Tests were performed on the handpiece including verification/validation testing to internal functional specifications which demonstrated that the device is substantially equivalent and complies with FDA requirements stated in Guidance Document "Dental Handpieces - Premarket Notification [510(k)] Submissions - Guidance for Industry and FDA Staff'. Sterilization has been validated in conformance to the FDA recognized consensus standard AAMI/ANSI/ISO 17665-1:2006; "Sterilization of Health Care Products – Moist
Image /page/2/Picture/4 description: In the image, a hand wearing a white glove is holding a blue surgical instrument. The instrument has a unique design with sharp edges and angles. The words "Powerful Partners" are visible at the bottom of the image.
Section 5: Page 3 of 4
3
Image /page/3/Picture/0 description: The image shows the logo for NSK, a Japanese manufacturer of bearings. The logo is white and is set against a blue background. The letters "NSK" are in a bold, sans-serif font, with the top of the "N" extending over the "S" and "K".
Heat - Part 1: Requirements for the Development, Validation, and Routine Control of a Sterilization Process for Medical Devices." Documentation was provided demonstrating that the General Cutting Contra Handpiece complies with the FDA requirements stated in Guidance for the "Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling - Guidance for Industry and Food and Drug Administration Staff". Biocompatibility evaluations were selected in accordance with AAMI/ANSI/ISO 10993-1: "Biological evaluation of medical devices - Part 1: Evaluation and testing" and FDA Guidance "Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process- Guidance for Industry and Food and Drug Administration Staff". In addition, testing for electrical safety was performed in accordance with ISO 14457.
- NAKANISHI, INC. considers the General Cutting Contra Handpiece to be Conclusion substantially equivalent to the predicate devices listed above. This conclusion is based on the similarities in primary intended use, principles of operation, functional design, and established medical use.
Image /page/3/Picture/3 description: The image shows a hand wearing a white glove holding a blue surgical instrument. The instrument has a sleek, modern design with sharp edges and a pointed tip. The words "Powerful Partners" are written in a small font at the bottom of the image.
4
Indications for Use
510(k) Number (if known) K182999
Device Name General Cutting Contra Handpiece
Indications for Use (Describe)
The General Cutting Contra Handpiece is powered by either an air-motor or electronic micromotor for use in general dentistry. The device is intended for cutting and grinding teeth, cavity preparations, tooth and crown preparations, finishing and trimming teeth and filling materials and removal of crowns and filling materials.
Type of Use (Select one or both, as applicable)
2 Prescription Use (Part 21 CFR 801 Subpart D)
_ Over-The-Counter Use (21 CFR 801 Subpart C)
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Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
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5
Image /page/5/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 blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
April 16, 2019
Nakanishi Inc. % Katie Reneson Regulatory Specialist Ken Block Consulting 800 East Campbell Road, Suite 202 Richardson, Texas 75081
Re: K182999
Trade/Device Name: General Cutting Contra Handpiece Regulation Number: 21 CFR 872.4200 Regulation Name: Dental Handpiece And Accessories Regulatory Class: Class I Product Code: EGS Dated: March 15, 2019 Received: March 18, 2019
Dear Katie Reneson:
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
6
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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/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 Tina Kiang, Ph.D. Acting Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure