(76 days)
The Concentrix High-Speed Handpieces are used by trained dental professionals for a variety of procedures including but not limited to caries and amalgam removal, restorative work and crown preparations.
The Concentrix High-Speed Handpieces are pneumatically driven, hand-held devices used by trained dental professionals to perform a variety of dental procedures.
The Concentrix MX is a non-fiber optic, 2/3 line fixed backend handpiece with a steel bearing manual chucking turbine. The Concentrix PX is a non-fiber optic, 2/3 line fixed backend handpiece with a steel bearing, push button autochuck turbine. The Concentrix FX is a non-fiber optic, 3/4 line fixed backend handpiece with a steel bearing, push button autochuck turbine. The Concentrix SX is a fiber optic, swivel handpiece with a steel bearing, push button autochuck turbine.
This document describes a 510(k) Premarket Notification for the DentalEZ, Inc. Concentrix High-Speed Handpiece Series. The submission focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study with specific acceptance criteria and performance metrics in the typical sense of a diagnostic or AI-powered device.
Therefore, many of the requested categories (e.g., sample size for test set, number of experts for ground truth, MRMC study, training set information) are not applicable to this type of regulatory submission, as it is not an AI/diagnostic device.
The "acceptance criteria" here are effectively the criteria for demonstrating substantial equivalence to the predicate device.
1. A table of acceptance criteria and the reported device performance
For a 510(k) submission for a dental handpiece, "acceptance criteria" are implied by demonstrating that the new device has the same technological characteristics, intended use, and performance as the predicate device, or that any differences do not raise new questions of safety and effectiveness.
| Acceptance Criterion (Implied for Substantial Equivalence) | Reported Device Performance / Assessment |
|---|---|
| Intended Use | The Concentrix High-Speed Handpieces are used by trained dental professionals for a variety of procedures including but not limited to caries and amalgam removal, restorative work and crown preparations. This is identical to the predicate device. |
| Technological Characteristics | Pneumatically driven, hand-held devices. Three models are non-fiber optic with fixed backend; one model (SX) is fiber optic with swivel connector. All incorporate steel bearing turbines requiring lubrication. MX uses a manual chucking mechanism; PX, FX, and SX use push-button autochuck. These characteristics are stated to be the same as the predicate devices, with design similarities noted for the specific models' features (e.g., fiber optic, chucking mechanism). |
| Design | Stated as "Similar" to the predicate device, implying that any differences in design are not considered to raise new questions of safety or effectiveness. |
| Materials | Stated as "Similar" to the predicate device, implying that any differences in materials are not considered to raise new questions of safety or effectiveness. |
| Performance | Stated as "Similar" to the predicate device. This implies that the device operates and functions effectively for its intended use, comparable to the predicate. Specific quantifiable performance metrics (e.g., RPM, torque) are not detailed in this summary but would have been part of the full submission to justify "Similar." |
| Sterility | Stated as "Identical" to the predicate device. |
| Biocompatibility | Stated as "Identical" to the predicate device. |
| Mechanical Safety | Stated as "Identical" to the predicate device. |
| Chemical Safety | Stated as "Identical" to the predicate device. |
| Energy Used/Delivered | Stated as "Identical" to the predicate device. |
| Compatibility with environment & other devices | Stated as "Identical" to the predicate device. |
| Where Used | Stated as "Identical" to the predicate device. |
| Standards Met | Stated as "Similar" to implicitly indicate compliance with relevant standards, similar to the predicate device. Specific standards are not listed in this summary but would be in the full submission. |
| Electrical Safety | Stated as "Not applicable" as these are pneumatically driven handpieces. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Not applicable. This is a 510(k) submission for a mechanical dental instrument, not a diagnostic or AI device that relies on a test set of patient data. The "study" here is a comparison to a predicate device based on engineering and design characteristics.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Not applicable. Ground truth for a diagnostic test set is not relevant to this device. The assessment is based on engineering evaluations and comparison to the predicate device characteristics.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. This concept is for diagnostic studies with human readers.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This is not an AI-assisted device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an algorithm or AI device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable. The "ground truth" for this submission is the performance and safety profile of the legally marketed predicate device (Star Dental 430 Series High Speed Handpiece, K960719), as established through its prior clearance and market history. The substantial equivalence relies on demonstrating that the new device is as safe and effective as this predicate.
8. The sample size for the training set
Not applicable. This is not an AI/machine learning device.
9. How the ground truth for the training set was established
Not applicable. This is not an AI/machine learning device.
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DentalEZ, Inc. StarDental Division
510(k) Premarket Notification Concentrix High-Speed Handpiece Series
Section 5
|330|
510(k) Summary
Section 5: 510(k) Summary
JAN 2 3 2012
Company:
DentalEZ Inc., StarDental Division Owner/operator number 2520265
Contact Person:
..:
Jim Watkins, Engineering/Quality Manager Luther Gates. Senior Product Development Engineer Kay Engle, Regulatory Affairs Supervisor DentalEZ Inc., StarDental Division 1816 Colonial Village Lane Lancaster, PA 17601 Phone: (717) 291-1161 (717) 391-2757 Fax:
Proprietary/Trade Name:
Concentrix High-Speed Handpiece Series - Concentrix MX, Concentrix PX, Concentrix FX and Concentrix SX
Classification:
Handpiece, Air-powered, Dental (21 C.F.R. § 872.4200, Product code EFB)
Predicate Device:
Star Dental 430 Series High Speed Handpiece (K960719)
The Concentrix High-Speed Handpieces have the same intended uses, methods of operation and technology as the previously cleared predicate devices.
Device Description:
The Concentrix High-Speed Handpieces are pneumatically driven, hand-held devices used by trained dental professionals to perform a variety of dental procedures.
The Concentrix MX is a non-fiber optic, 2/3 line fixed backend handpiece with a steel bearing manual chucking turbine. The Concentrix PX is a non-fiber optic, 2/3 line fixed backend handpiece with a steel bearing, push button autochuck
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turbine. The Concentrix FX is a non-fiber optic, 3/4 line fixed backend handpiece with a steel bearing, push button autochuck turbine. The Concentrix SX is a fiber optic, swivel handpiece with a steel bearing, push button autochuck turbine.
Intended Use:
The Concentrix High-Speed Handpieces are used by trained dental professionals for a variety of procedures including but not limited to caries and amalgam removal, restorative work and crown preparations.
Technological Characteristics:
The Concentrix High-Speed Handpieces are pneumatically driven, hand-held devices which have the same technological characteristics as the predicate devices. Three of the handpieces (MX, PX, FX) are non-fiber optic with a fixed backend which does not allow the handpiece to swivel when attached to tubing. The fourth handpiece (SX) contains fiber optics and is designed to accommodate a type 3 swivel connector.
All of the Concentrix handpieces incorporate steel bearing turbines which require lubrication. The recommended lubricant is Dentalube II, which is manufactured by StarDental (K070869). The Concentrix MX is the only handpiece in the series that uses an existing manual type chucking mechanism. The Concentrix PX, FX and SX versions all use an existing push-button type chucking mechanism.
| Technological Characteristics | Predicate Device Comparisonconclusion |
|---|---|
| Indication for use | Identical |
| Target population | Identical |
| Design | Similar |
| Materials | Similar |
| Performance | Similar |
| Sterility | Identical |
| Biocompatibility | Identical |
| Mechanical safety | Identical |
| Chemical safety | Identical |
| Energy used and/or delivered | Identical |
| Compatibility with environmentand other devices | Identical |
| Where used | Identical |
| Standards met | Similar |
| Electrical Safety | Not applicable |
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Substantial Equivalence:
The former and and second and the comments of the comments of
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The determination of substantial equivalence is based on the premise that the proposed device and the predicate devices have the same intended use and technology and are similar in design.
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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle, with its wings forming three distinct strokes. The eagle's head is not clearly defined, and its body is represented by a series of curved lines.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Mr. Jim Watkins Engineering/Quality Manager DentalEZ, Inc. StarDental Divison 1816 Colonial Village Lane Lancaster, PA 17601
JAN 2 3 2012
Re: K113301
Trade/Device Names: Concentrix High-Speed Handpiece Series - Concentrix MX, Concentrix PX, Concentrix FX, and Concentrix SX Regulation Number: 21 CFR 872.4200 Regulation Name: Dental Handpiece and Accessories Regulatory Class: I Product Code: EFB Dated: November 4, 2011 Received: November 8, 2011
Dear Mr. Watkins:
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 Ameradments, 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.
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Page 2 - Mr. Watkins
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 (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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices /ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
hh for
Anthony D. Watson, B.S., M.S., M.B.A. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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| Indications for Use | |
|---|---|
| 510(k) Number (if known): | K113301 |
Concentrix High-Speed Handpiece Series - Concentrix MX, Device Name: Concentrix PX, Concentrix FX and Concentrix SX
Indications for Use:
The Concentrix High-Speed Handpieces are used by trained dental professionals for a The Concentral High Operation of limited to caries and amalgam removal, restorative work and crown preparations.
CAUTION: Federal law restricts this device to sale by or on the order of a dentist.
Prescription Use (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)
Susan Runner
Page 1 of 1
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: K113301
§ 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.