(140 days)
No
The device description and performance studies focus on mechanical and material properties, with no mention of AI/ML or data processing capabilities.
Yes
The device is used for medical procedures (caries and amalgam removal, restorative work, and crown preparations) which are therapeutic in nature, aimed at treating conditions and restoring function.
No
The device description and intended use clearly state that it is a tool for performing dental procedures (e.g., caries and amalgam removal, restorative work), not for diagnosing conditions.
No
The device description clearly outlines a physical, pneumatically driven handpiece constructed of stainless steel and aluminum, with internal air and water tubes, a turbine assembly, and bearings. This is a hardware device, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is used for dental procedures like caries and amalgam removal, restorative work, and crown preparations. These are direct interventions on the patient's body.
- Device Description: The description details a mechanical handpiece used for drilling and shaping, not for analyzing samples from the body.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (like blood, urine, tissue) in vitro (outside the body) to provide information for diagnosis, monitoring, or screening.
IVD devices are specifically designed to perform tests on samples taken from the human body. This device is a surgical/procedural tool used directly on the patient.
N/A
Intended Use / Indications for Use
The Concentrix MX-AC High-Speed Handpiece is used by trained dental professionals for a variety of procedures including but not limited to caries and amalgam removal, restorative work and crown preparations.
Product codes (comma separated list FDA assigned to the subject device)
EFB
Device Description
The Concentrix MX-AC High-Speed Handpiece is a pneumatically driven, non-fiber optic, 2/3 line fixed backend handpiece that is capable of reaching rotational speeds of 302,000 rpms at a recommended air pressure of 32 PSI.
The handpiece is constructed of stainless steel, including the internal air and water tubes which provide drive air to the turbine assembly and cooling water to the work site. The stainless steel and aluminum air driven turbine assembly provides spin to the bur and incorporates steel lubricated bearings and a push button autochuck.
The burs used with the Concentrix MX-AC High Speed Handpiece are ISO 1797-1, type 2 burs. Only burs with hardened, tempered steel shanks or carbide shanks should be used.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
trained dental professionals
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 following tests were conducted to evaluate the functional performance and safety the Concentrix MX-AC High-Speed Handpiece:
- ISO 14457:2012 Dentistry— Handpieces and Motors
- ISO 60601-1:2005 Medical Electrical Equipment – Part 1: General requirements for basic safety and essential performance
The test results confirm that the Concentrix MX-AC High-Speed Handpiece conforms to the requirements of ISO 14457:2012 and ISO 60601-1:2009 and is substantially equivalent for use as a high-speed handpiece.
Biocompatibility testing was conducted in accordance with Good Laboratory Practices regulations (FDA, 21 CFR, Part 58-Good Laboratory Practice for Nonclinical Laboratory Studies). ISO 10993-10 "Biological Evaluation of Medical Devices, Part 10: Tests for Irritation and Skin Sensitization" and ISO 10993-12 "Biological Evaluation of Medical Devices, Part 12: Sample Preparation and Reference Materials" and the FDA Guidance Document "Use of International Stnadard ISO 10993-1, "Biological evaluation of medical devices – Part 11: Evaluation and testing within a risk management process", issued on June 16, 2016. Testing completed on this device includes:
- Cytotoxicity per ISO 10993-5
- Sensitization per ISO 10993-10
- Irritation per ISO 10993-10
Sterilization validation for the sterilization of the handpiece which incorporate the turbine assembly was performed in accordance to ANSI/AAMI ST79:2010 & A4:2013, AAMI/ANSI/ISO 14937:2009 and ANSI/AAMI ST81:2004 (R2010).
Cleaning and disinfection validation was conducted per the FDA Guidance Document for "Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling" issued on March 17, 2015.
A risk analysis for the Concentrix MX-AC High-Speed Handpiece was developed using ISO14971:2012.
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 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 consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, and the word "ADMINISTRATION" in a smaller font size below that.
March 28, 2018
DentalEZ, Inc. Kay Engle Regulatory Affairs/OA Supervisor 1816 Colonial Village Lane Lancaster, Pennsylvania 17601
Re: K173465
Trade/Device Name: Concentrix MX-AC High-Speed Handpiece Regulation Number: 21 CFR 872.4200 Regulation Name: Dental Handpiece And Accessories Regulatory Class: Class I Product Code: EFB Dated: February 26, 2018 Received: February 27, 2018
Dear Kay Engle:
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. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
1
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); 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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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.
Andrew I. Steen -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
Indications for Use
510(k) Number (if known) K173465
Device Name Concentrix MX-AC High-Speed Handpiece
Indications for Use (Describe)
The Concentrix MX-AC High-Speed Handpiece is used by trained dental professionals for a variety of procedures including but not limited to caries and amalgam removal, restorative work and crown preparations.
| 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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3
Image /page/3/Picture/1 description: The image contains the logo for DentalEZ, Inc., StarDental Division. The logo features a stylized graphic element with overlapping curved lines in shades of gray and green. To the right of the graphic is the text "DentalEZ" in a bold, sans-serif font, with the letters "IEZ" slightly smaller and in a different color. Below the logo is the text "DentalEZ, Inc., StarDental Division" in a smaller, sans-serif font.
Concentrix MX-AC High Speed Handpiece
510(k) Summary K173465
SUBMITTER l.
DentalEZ Inc., StarDental Division 1816 Colonial Village Lane Lancaster, PA 17601 Phone: (717) 291-1161 Fax: (717) 391-2757 Contact Person: Kay Engle, Regulatory Affairs/QA Supervisor Email: KEngle@ DentalEZ.com Rob Young, Senior Director of Engineering Email: RYoung@DentalEZ.com March 26, 2018
II. DEVICE
Name of the Device: Concentrix MX-AC High-Speed Handpiece Common or Usual Name: High-Speed Handpiece Air-Powered Classification Name: Dental Handpieces and Accessories Regulation Number: 21 C.F.R. § 872.4200 Regulatory Class: I Product Code: EFB
III. PREDICATE DEVICE
Primary Predicate: Concentrix High-Speed Handpiece Series - Concentrix MX, Concentrix PX Concentrix FX and Concentrix SX (K113301) as manufactured by StarDental Reference Device: Lube Free Autochuck Turbine with Vortex Air Seal for Use with StarDental 430 Series Lube Free High Speed Dental Handpieces (K982593)
IV. DEVICE DESCRIPTION:
The Concentrix MX-AC High-Speed Handpiece is a pneumatically driven, non-fiber optic, 2/3 line fixed backend handpiece that is capable of reaching rotational speeds of 302,000 rpms at a recommended air pressure of 32 PSI.
The handpiece is constructed of stainless steel, including the internal air and water tubes which provide drive air to the turbine assembly and cooling water to the work site. The stainless steel and aluminum air driven turbine assembly provides spin to the bur and incorporates steel lubricated bearings and a push button autochuck.
The burs used with the Concentrix MX-AC High Speed Handpiece are ISO 1797-1, type 2 burs. Only burs with hardened, tempered steel shanks or carbide shanks should be used.
4
V. INDICATIONS FOR USE
The Concentrix MX-AC High-Speed Handpiece is used by trained dental professionals for a variety of procedures including but not limited to caries and amalgam removal, restorative work and crown preparations.
VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE:
The Concentrix MX-AC High-Speed Handpiece and the predicate device have the sa me technologicalcharacteristics:
- . Intended use
- Method of operation
- Use of the same base materials
- Lubrication requirements
- Autoclavable
The following technological differences exist between the Concentrix MX-AC High-Speed Handpiece and the predicate:
- Autochuck turbine .
- Free run speed
- . End cap assembly
The proposed Concentrix MX-AC High-Speed Handpiece has the same technological similarities and differences as noted above for the primary predicate. The reference predicate uses a push button autochuck feature which is incorporated into the proposed device.
The difference between the proposed devices and the primary predicate device is the type of chucking mechanism used in the turbine assembly and the end cap assembly. These differences do not affect the performance of the device.
The following table summarizes the comparison of the proposed Concentrix MX-AC High-Speed Handpiece to the primary predicate and reference predicate for indications for use and technological characteristics.
| Device | Proposed device:
Concentrix MX-AC High-
Speed Handpiece
(K173465) | Primary Predicate:
Concentrix High Speed
Handpiece Series-
Concentrix MX,
Concentrix PX,
Concentrix FX and
Concentrix SX (K113301) | Reference Device:
Lube Free Autochuck
Turbine with Vortex Air
Seal for Use with
StarDental 430 Series
Lube Free High Speed
Dental Handpieces
(K982593) |
|-------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for
Use | The Concentrix MX-AC
High-Speed Handpiece is
used by trained dental
professionals for a variety
of procedures including
but not limited to caries | The Concentrix High-
Speed Handpieces are
used by trained dental
professionals for a variety
of procedures including
but not limited to caries | High-speed dental
handpieces are used
intraorally by trained
dental professionals for
drilling and preparation
of dental caries for |
| Device | Proposed device:
Concentrix MX-AC High-
Speed Handpiece
(K173465) | Primary Predicate:
Concentrix High Speed
Handpiece Series-
Concentrix MX,
Concentrix PX,
Concentrix FX and
Concentrix SX (K113301) | Reference Device:
Lube Free Autochuck
Turbine with Vortex Air
Seal for Use with
StarDental 430 Series
Lube Free High Speed
Dental Handpieces
(K982593) |
| | and amalgam removal,
restorative work and
crown preparations | and amalgam removal,
restorative work and
crown preparations | restoration, such as
fillings. Autochuck
turbines are used in place
of a bur tool to facilitate
bur changing. |
| Product Code | EFB | EFB | EFB |
| Operational
Mode | Air driven | Air driven | Air driven |
| Type of chuck | Autochuck | Manual chuck:MX | Autochuck |
| Operating
Pressure | 32 PSI | 32 PSI | Dependent on the
handpiece |
| Coupling Type | ISO 9168, Type 1 | MX: ISO 9168, Type 1 | N/A |
| Bur Dimension | ISO 1797-1, Type 2 | ISO 1797-1, Type 2 | ISO 1797-1, Type 2 |
| Material
composition | Stainless steel | Stainless steel | Stainless steel |
| Components | High speed pneumatic
driven
Handpiece.
Lubricated steel bearing
autochuck turbine
assembly
Pushbutton end cap | High speed pneumatic
driven
Handpiece.
Lubricated steel bearing,
manual chuck turbine
assembly
Single piece threaded end
cap | Lube free ceramic
autochuck turbine
assembly
Pushbutton end cap |
| Biocompatibility | Stainless steel
Steel bearings
Biocompatibility tests
were conducted in
accordance with the
requirements of ISO
10993-10 and ISO 10993-
12. Test results indicate
the device is non-
cytotoxic, non-sensitizing
and non-irritating. | Stainless steel
Steel bearings | Stainless steel
Ceramic bearings |
| Device | Proposed device:
Concentrix MX-AC High-
Speed Handpiece
(K173465) | Primary Predicate:
Concentrix High Speed
Handpiece Series-
Concentrix MX,
Concentrix PX,
Concentrix FX and
Concentrix SX (K113301) | Reference Device:
Lube Free Autochuck
Turbine with Vortex Air
Seal for Use with
StarDental 430 Series
Lube Free High Speed
Dental Handpieces
(K982593) |
| Sterilization | Sterilization validation in
accordance with
ANSI/AAMI ST79:2010 &
A4:2013, AAMI/ANSI/ISO
14937:2009 and
ANSI/AAMI ST81:2004
(R2010) | Sterilization validation in
accordance with
ANSI/AAMI ST79:2010 &
A4:2013, AAMI/ANSI/ISO
14937:2009 and
ANSI/AAMI ST81:2004
(R2010) | Sterilization validation
report references AAMI
TIR No. 12-1994 |
| Performance | Variable 302,000 rpm
+/- 10% | Variable 385,000 rpm
+/- 10% | Variable 430,000 rpm,
+/- 10% |
| Risk analysis | ISO14971:2012 Medical
devices - Application of
risk management to
medical devices | ISO14971:2000 Medical
devices - Application of
risk management to
medical devices | Risk Analysis at time of
submission unknown.
Current risk analysis per
ISO 14971:2012 —
Application of risk
management to medical
devices |
5
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VII. PERFORMANCE DATA
The following tests were conducted to evaluate the functional performance and safety the Concentrix MX-AC High-Speed Handpiece:
- ISO 14457:2012 Dentistry— Handpieces and Motors
- . ISO 60601-1:2005 Medical Electrical Equipment – Part 1: General requirements for basic safety and essential performance
The test results confirm that the Concentrix MX-AC High-Speed Handpiece conforms to the requirements of ISO 14457:2012 and ISO 60601-1:2009 and is substantially equivalent for use as a high-speed handpiece.
Biocompatibility testing was conducted in accordance with Good Laboratory Practices regulations (FDA, 21 CFR, Part 58-Good Laboratory Practice for Nonclinical Laboratory Studies). ISO 10993-10 "Biological Evaluation of Medical Devices, Part 10: Tests for Irritation and Skin Sensitization" and ISO 10993-12 "Biological Evaluation of Medical Devices, Part 12: Sample Preparation and Reference Materials" and the FDA Guidance Document "Use of International Stnadard ISO 10993-1, "Biological evaluation of medical devices – Part 11: Evaluation and testing within a risk management process", issued on June 16, 2016. Testing completed on this device includes:
- . Cytotoxicity per ISO 10993-5
- Sensitization per ISO 10993-10
- . Irritation per ISO 10993-10
7
Sterilization validation for the sterilization of the handpiece which incorporate the turbine assembly was performed in accordance to ANSI/AAMI ST79:2010 & A4:2013, AAMI/ANSI/ISO 14937:2009 and ANSI/AAMI ST81:2004 (R2010).
Cleaning and disinfection validation was conducted per the FDA Guidance Document for "Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling" issued on March 17, 2015.
A risk analysis for the Concentrix MX-AC High-Speed Handpiece was developed using ISO14971:2012.
VIII. CONCLUSION
Based upon the comparison of technological characteristics, demonstrated through bench testing and intended use, the Concentrix MX-AC High-Speed Handpiece is substantially equivalent to the predicate devices.