(467 days)
No
The description focuses on the mechanical and electrical aspects of the device, including battery power, wireless communication (BLE), and variable speed control based on foot pedal actuation. There is no mention of AI or ML algorithms for data analysis, decision-making, or adaptive control.
No.
The device is used for cleaning and polishing tooth surfaces, which is a mechanical procedure, not a therapeutic treatment for disease or injury.
No
This device is solely intended for the cleaning and polishing of tooth surfaces and fillings, which is a therapeutic rather than a diagnostic function.
No
The device description clearly outlines multiple hardware components including a handpiece, nosecone, cradle, power supply, charging cord, and wireless foot controller. The performance studies also include hardware-specific testing like sterilization, electrical safety, and biocompatibility. While there is mention of software validation, the device is fundamentally a hardware system with integrated software for control and communication.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "to perform cleaning and polishing of tooth surfaces and fillings." This is a mechanical action performed directly on the patient's body (teeth and fillings).
- Device Description: The description details a cordless handpiece, foot controller, and accessories used for mechanical cleaning and polishing. There is no mention of analyzing samples from the human body (like blood, urine, tissue, etc.) or providing information about a patient's health status based on such analysis.
- Lack of IVD Characteristics: IVD devices are designed to examine specimens derived from the human body to provide information for diagnosis, monitoring, or screening. This device does not perform any such function.
The device is clearly a dental tool used for a physical procedure within the mouth, not for in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
Battery driven electrical drive unit with wireless foot controller for use with disposable prophylaxis angles in hygiene operatory to perform cleaning and polishing of tooth surfaces and fillings.
Product codes (comma separated list FDA assigned to the subject device)
EKX
Device Description
The proposed device, the Young INFINITY Cordless Handpiece System, is a cordless handpiece which is intended for use by a dental clinician during dental cleaning and polishing of tooth surfaces and fillings.
The Young INFINITY Cordless Handpiece System is comprised of a cordless, battery-powered handpiece, a removable nosecone, a cradle for the cordless handpiece, a direct current (DC) power supply and charging cord, and a wireless foot controller.
Accessories to the Young INFINITY Cordless Handpiece System include a single-use doriot style Disposable Prophy Angle (DPA), which can be purchased from any DPA manufacturer. Additionally, the Young Infinity Cordless Handpiece System must be used with a disposable barrier (cleared as Class II, Product Classification Code PEM, under premarket notification K151123 in 03/03/2016 as Cover-It Barrier Film).
The handpiece features a removable nosecone that is to be cleaned and steam sterilized prior to first use and after each patient use.
The handpiece utilizes an on-board user control for on/off and an LED indicator to communicate handpiece battery life, handpiece battery charging, foot control low power level, excessive pressure being applied, and wireless pairing status, The handpiece can only be operated by the appropriately paired wireless foot controller.
The Young INFINITY Cordless Handpiece System is operated by using a wireless foot controller, where the amount of vertical actuation on the wireless foot controller correlates to the speed of the handpiece supplied to the DPA. The corresponding variable speed range of the DPA is between 500RPM and 3000RPM.
The wireless foot controller operates using a Bluetooth low energy (BLE) communication protocol. When the handpiece has been turned ON, engaging the wireless foot controller activates the (BLE) mode of both the cordless handpiece and the wireless foot controller. The wireless foot controller features LEDs to indicate when the BLE mode on the foot controller has been activated, battery charging and adequate battery power level.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
tooth surfaces and fillings
Indicated Patient Age Range
Not Found
Intended User / Care Setting
dental clinician, hygiene operatory
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)
Non-Clinical Performance Data: Testing included verification of component specifications, speed and torque control, connectivity of handpiece / foot controller communication, battery life, noise testing, software validation, chemical compatibility of housing materials, sterilizability, biocompatibility, fluid ingress, and electrical equipment safety. Tests were also performed to compare the speed, torque, weight, and dimensions of the Young INFINITY cordless handpiece system to the Midwest RDH Freedom Cordless Prophy System. The following testing was conducted
- Sterilization/Cleaning validation activities per ISO 17665-1 and ISO 17665-2. Reprocessing assessment and validation per the FDA Guidance Document for Reprocessing Medical Devices in Heath Care Setting: Validation Methods and Labeling including evaluation of design/mitigation methods to prevent contamination of the internal motor.
- Electrical Safety testing per IEC 60601-1 and Electromagnetic Compatibility . testing per IEC 60601-1-2.
- Biocompatibility validation activities per FDA Guidance Document for Use of . ISO 10993-1. Cytotoxicity testing on the final finished manufactured device per ISO 10993-5.
- Risk Analysis (hardware and software) per ISO 14971 .
- Software documentation for software of moderate level of concern per the . FDA Guidance Document Software Contained in Medical Devices
- Hardware Performance/Safety Verification/Validation activities including conformance to ISO 14457 Dentistry -- Handpieces and motors
The results of this performance testing, combined with design and intended use comparison with the predicate device, Midwest RDH Freedom Cordless system (K110753), support substantial equivalence to the 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 contains the logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
Young Dental Manufacturing Co 1, LLC Brian Prange Sr. Engineer, New Product Development 13705 Shoreline Ct East Earth City, Missouri 63045
Re: K171377
Trade/Device Name: Young INFINITY Cordless Handpiece System Regulation Number: 21 CFR 872.4200 Regulation Name: Dental Handpiece and Accessories Regulatory Class: Class I Product Code: EKX Dated: July 19, 2018 Received: July 20, 2018
Dear Brian Prange:
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/cdrl/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 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
August 20, 2018
1
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 medical devices and radiation-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,
Mary S. Runner -S
For Tina Kiang, Ph.D. Acting Director Division of Anesthesiology. General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
7.1 Indications for Use Statement
Indications for Use
510(k) Number: K171377
Device Name: Young INFINITY Cordless Handpiece System
Battery driven electrical drive unit with wireless foot controller for use with disposable prophylaxis angles in hygiene operatory to perform cleaning and polishing of tooth surfaces and fillings.
| Prescription Use | X |
|---|---|
| (Part 21 CFR 801 Subpart D) | |
| AND/OR | |
| Over-The-Counter Use | |
| (21 CFR 801 Subpart C) |
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
3
510(k) Summary
As required by the Safe Medical Devices Act (SMDA) of 1990 and in accordance with 21 CFR § 807.93, 510(k) summary is provided.
DATE: August 17, 2018
l. SUBMITTER
Brian Prange 13705 Shoreline Ct. E. Earth City, MO 63045
Tel: 314-344-0010 Email: bprange@youngdental.com
II. OFFICIAL CORRESPONDENCE/CONTACT PERSON
Brian Prange 13705 Shoreline Ct. E. Earth City, MO 63045
Tel: 314-344-0010 Email: bprange@youngdental.com
III. 510(K) PREPARER
Scott Edwards 8888 Keystone Crossing Suite 1550 Indianapolis, IN 46240
Tel: 317-968-9531 Email: sedwards@maetrics.com
IV. DEVICE
Brand Name of Device: Young INFINITY Cordless Handpiece System Common or Usual Name: Handpiece, Direct Drive, AC Powered Classification Name: Dental Handpiece and Accessories Regulation: 21 CFR 872.4200 Device Classification: Class: I Product Code: EKX
4
V. PREDICATE DEVICE
Trade Name: Midwest RDH Freedom Cordless Prophy System Common Name: Prophy System 510(k) Number: K110753 (Decision Date: June 6, 2011) Manufacturer: Dentsply International Inc.
VI. DEVICE DESCRIPTION
The proposed device, the Young INFINITY Cordless Handpiece System, is a cordless handpiece which is intended for use by a dental clinician during dental cleaning and polishing of tooth surfaces and fillings.
The Young INFINITY Cordless Handpiece System is comprised of a cordless, battery-powered handpiece, a removable nosecone, a cradle for the cordless handpiece, a direct current (DC) power supply and charging cord, and a wireless foot controller.
Accessories to the Young INFINITY Cordless Handpiece System include a single-use doriot style Disposable Prophy Angle (DPA), which can be purchased from any DPA manufacturer. Additionally, the Young Infinity Cordless Handpiece System must be used with a disposable barrier (cleared as Class II, Product Classification Code PEM, under premarket notification K151123 in 03/03/2016 as Cover-It™ Barrier Film).
The handpiece features a removable nosecone that is to be cleaned and steam sterilized prior to first use and after each patient use.
The handpiece utilizes an on-board user control for on/off and an LED indicator to communicate handpiece battery life, handpiece battery charging, foot control low power level, excessive pressure being applied, and wireless pairing status, The handpiece can only be operated by the appropriately paired wireless foot controller.
The Young INFINITY Cordless Handpiece System is operated by using a wireless foot controller, where the amount of vertical actuation on the wireless foot controller correlates to the speed of the handpiece supplied to the DPA. The corresponding variable speed range of the DPA is between 500RPM and 3000RPM.
5
The wireless foot controller operates using a Bluetooth low energy (BLE) communication protocol. When the handpiece has been turned ON, engaging the wireless foot controller activates the (BLE) mode of both the cordless handpiece and the wireless foot controller. The wireless foot controller features LEDs to indicate when the BLE mode on the foot controller has been activated, battery charging and adequate battery power level.
VII. INDICATIONS FOR USE
Battery driven electrical drive unit with wireless foot controller for use with disposable prophylaxis angles in hygiene operatory to perform cleaning and polishing of tooth surfaces and fillings.
6
SUBSTANTIAL EQUIVALENCE VIII.
K110753: Midwest RDH Freedom Cordless Prophy System
| Product Comparison - Similarities and Differences | |||
|---|---|---|---|
| Characteristic | Proposed Device | Midwest RDH | |
| Freedom Cordless | |||
| Prophy System | Similarities & | ||
| Differences | |||
| Manufacturer | Young Dental | DENTSPLY | |
| 510(k) Number | K171377 | K110753 | |
| Class | I | I | No difference |
| Regulation Number | 872.4200 | 872.4200 | No difference |
| Intended Use / | |||
| Indications for Use | Battery driven | ||
| electrical drive unit | |||
| with wireless foot | |||
| controller for use with | |||
| disposable | |||
| prophylaxis angles in | |||
| hygiene operatory to | |||
| perform cleaning and | |||
| polishing of tooth | |||
| surfaces and fillings. | The MIDWEST® RDH | ||
| FREEDOM™ Cordless | |||
| Prophy System is a | |||
| high-performance | |||
| cordless prophylaxis | |||
| handpiece with a | |||
| wireless foot pedal | |||
| for use with Freedom | |||
| disposable | |||
| prophylaxis angles in | |||
| a hygiene operatory | |||
| to perform cleaning | |||
| and polishing | |||
| procedures on teeth. | No significant | ||
| differences. Both | |||
| devices have the | |||
| same components, | |||
| and are intended to | |||
| clean and polish | |||
| teeth. The proposed | |||
| device has small | |||
| differences in user | |||
| population, but are | |||
| more syntax than | |||
| practical differences. | |||
| Product Code | EKX | EKX | No difference |
| Use | Rx Only | Rx Only | No difference |
| Handpiece geometry | Cylindrical shape with | ||
| reverse radius | |||
| geometry to aid in | |||
| device handling. | |||
| Tapered, swiveled | |||
| nosecone area. | Cylindrical shape with | ||
| tapered nosecone. | Both shapes are | ||
| designed to fit in the | |||
| user's hand | |||
| Handpiece Power | Lithium-Ion Battery | ||
| capable of being re- | |||
| charged multiple | |||
| times by inclusion of | |||
| an AC/DC power | |||
| supply. | Lithium-Ion Battery | ||
| capable of being re- | |||
| charged multiple | |||
| times by inclusion of | |||
| an AC/DC power | |||
| supply. | No difference | ||
| Handpiece Charge | |||
| time | Approximately 2 | ||
| hours | At least 90 minutes | Both products can | |
| be charged over night |
| Table 1. Device Comparison (Similarities and Differences) |
|---|
| ------------------------------------------------------------ |
7
Young Dental Manufacturing Co. | Premarket Notification 510(k) Submission Under 21 CFR § 807.87 for Young INFINITY Cordless Handpiece System
| Product Comparison – Similarities and Differences | |||
|---|---|---|---|
| Characteristic | Proposed Device | Midwest RDH | |
| Freedom Cordless | |||
| Prophy System | Similarities & | ||
| Differences | |||
| Handpiece | |||
| Dimensions | 25mm Dia x 156mm | 30mm Dia X 190mm | |
| length | Both products allow | ||
| for similar interaction | |||
| with the user. | |||
| Foot Pedal Power | Foot pedal contains a | ||
| lithium ion battery | |||
| capable of being re- | |||
| charged multiple | |||
| times by inclusion of | |||
| AC/DC power supply. | Foot pedal contains a | ||
| lithium ion battery | |||
| capable of being re- | |||
| charged multiple | |||
| times by inclusion of | |||
| AC/DC power supply. | No difference | ||
| Prophy Angle Fit | Similar to most | ||
| corded handpieces on | |||
| the market today, our | |||
| device will have a | |||
| Doriot style nose | |||
| which allows most | |||
| prophy angles to be | |||
| used on the device. | Proprietary | ||
| Disposable Prophy | |||
| Angles that work | |||
| exclusively with the | |||
| system. | The prophy angle fit | ||
| does not impact the | |||
| user experience | |||
| during cleaning and | |||
| polishing procedures. | |||
| Nose Cone | Nose cone will | ||
| swivel. The nosecone | |||
| will also be | |||
| removable and | |||
| autoclavable for | |||
| infection control. | Contains a | ||
| removable, | |||
| autoclavable outer | |||
| sheath for infection | |||
| control. | Both products aid | ||
| users reprocessing |
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8
| Characteristic | Proposed Device | Midwest RDH
Freedom Cordless
Prophy System | Similarities &
Differences |
|---------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Infection Control /
Sterilization Method | Remove nosecone
and sterilize via
autoclave.
The nosecone is to be
cleaned and sterilized
prior to first use and
after each patient
Do not sterilize the
handpiece cradle,
handpiece, or foot
control. These
devices may only be
disinfected. The
handpiece is to be
covered with an FDA
cleared disposable
barrier sleeve. | Outer sheath is to be
to cleaned and
sterilized prior to first
use and after each
patient.
Do not sterilize the
inner module or
charging station.
These may be wiped
with intermediate
level disinfectants.
The handpiece is to
be covered with an
FDA cleared
disposable barrier
sleeve. | Both products utilize
a steam sterilization
procedure for the
removeable
nosecone, and
disinfection
procedure for the
handpiece. |
| Lubrication Method | Lubricant Free motor.
Do not use
lubrication. | Lubricant Free motor.
Do not use
lubrication. | No difference |
| Product Comparison - Similarities and Differences | | | |
| Characteristic | Proposed Device | Midwest RDH
Freedom Cordless
Prophy System | Similarities &
Differences |
| User Interface on
Handpiece | That handpiece will
have a POWER
button, which will
enable connection to
the foot pedal for
activation. | Handpiece does not
have any user
interface, and the
handpiece is
controlled exclusively
by the cordless foot
pedal. | Both devices have
clear methods for
turning the device ON |
| Auto-Off | Handpiece will enter
a standby mode if idle
for more than 4
minutes. The user
would then have to
press the POWER
button to activate the
handpiece again. | Handpiece will enter
standby mode if idle
for more than 1
minute
Product goes into
enhanced battery-
saving mode after 1
week of non-use. | Both devices have
clear methods for
automatically turning
the device OFF to
save battery power.
The timing of auto-off
sequences does not
impact use. |
| Mode of Operation | Rotary | Rotary | No difference |
| Speed Control | Speed is controlled
and adjusted through
varying pressure on
the foot pedal. The
motor itself has a
limit of 3000RPM
(±10%). | Speed is controlled
and adjusted through
varying pressure on
the foot pedal. | No difference |
| Speed Range | 500 - 3000 RPM
(±10%) | 3000 RPM MAX | The top speed is the
same on both devices.
The low end speed
limit does not impact
use. |
| Torque Range | 1Ncm torque | 10 mNm | Both devices deliver
similar torque / speed
profiles, and have
very similar motors. |
| Product Comparison - Similarities and Differences | | | |
| Characteristic | Proposed Device | Midwest RDH
Freedom Cordless
Prophy System | Similarities &
Differences |
| Temperature | 10 - 35°C | 10-40°C | Both devices utilize
the same low-end
temperature, and
have high-end
temperature ranges
consistent with
storage,
transportation and
use conditions in the
field today |
| Humidity | 8-80% RH | 45-95% RH | Both devices have
humidity ranges
consistent with
storage,
transportation and
use conditions in the
field today |
| Handpiece | પ્રદર | YES | No difference |
| Foot Pedal | પ્રદર | YES | No difference |
| Handpiece Holding
Station | ત્ત્વન્યું પ્રદર્શ | YES | No difference |
| Handpiece Sleeves | ત્ત્વન્યું પ્રદર્શ | પ્રદર | No difference |
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9
10
As indicated in Table 1, all relevant comparison items are very similar, and do not exhibit any changes that would impact intended use or the user experience.
11
IX. PERFORMANCE DATA DEMONSTRATING SUBSTANTIAL EQUIVALENCE
The Young INIFNITY Cordless Handpiece System has the same intended use and operating principles, with similar features, and functional and performance characteristics as the previously-cleared devices. The device is designed to comply with relevant federal and international safety and performance standards. Conformance to these standards, coupled with no changes in the Indications for Use and no change in the fundamental scientific technology demonstrates substantial equivalence to the predicate devices.
Non-Clinical Performance Data: Testing included verification of component specifications, speed and torque control, connectivity of handpiece / foot controller communication, battery life, noise testing, software validation, chemical compatibility of housing materials, sterilizability, biocompatibility, fluid ingress, and electrical equipment safety. Tests were also performed to compare the speed, torque, weight, and dimensions of the Young INFINITY cordless handpiece system to the Midwest RDH Freedom Cordless Prophy System. The following testing was conducted
- · Sterilization/Cleaning validation activities per ISO 17665-1 and ISO 17665-2. Reprocessing assessment and validation per the FDA Guidance Document for Reprocessing Medical Devices in Heath Care Setting: Validation Methods and Labeling including evaluation of design/mitigation methods to prevent contamination of the internal motor.
- Electrical Safety testing per IEC 60601-1 and Electromagnetic Compatibility . testing per IEC 60601-1-2.
- Biocompatibility validation activities per FDA Guidance Document for Use of . ISO 10993-1. Cytotoxicity testing on the final finished manufactured device per ISO 10993-5.
- Risk Analysis (hardware and software) per ISO 14971 .
- Software documentation for software of moderate level of concern per the . FDA Guidance Document Software Contained in Medical Devices
- · Hardware Performance/Safety Verification/Validation activities including conformance to ISO 14457 Dentistry -- Handpieces and motors
The results of this performance testing, combined with design and intended use comparison with the predicate device, Midwest RDH Freedom Cordless system (K110753), support substantial equivalence to the predicate device.
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X. SUMMARY OF SIMILARITIES AND DIFFERENCES
The intended use and indications for use of the proposed Young INFINITY Cordless Handpiece System are equivalent to the legally marked predicate device, Midwest RDH Freedom Cordless Prophy System. The fundamental scientific technology of the proposed device is unchanged from the legally marketed predicate devices. The predicate device and submitted device share similar design features including battery type, mode of operation, and speed range. The devices share similar methods of control systems and operation. The devices share similar performance specifications including RPM and energy type.
XI. CONCLUSIONS
The Young INIFNITY Cordless Handpiece System is substantially equivalent to the listed predicate device, Midwest RDH Freedom Cordless Prophy System. The new device has the same intended use and operating principles, with similar features, and functional and performance characteristics.
13
Young Dental Manufacturing Co. | Premarket Notification 510(k) Submission Under 21 CFR § 807.87 for Young INFINITY Cordless Handpiece System
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