CONCENPIECE,HIGH-SPEED HANDPIECE SERIES

K113301 · Dentalez, Inc. · EFB · Jan 23, 2012 · Dental

Device Facts

• Record ID: K113301
• Device Name: CONCENPIECE,HIGH-SPEED HANDPIECE SERIES
• Applicant: Dentalez, Inc.
• Product Code: EFB · Dental
• Decision Date: Jan 23, 2012
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.4200
• Device Class: Class 1
• Attributes: Therapeutic

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. CAUTION: Federal law restricts this device to sale by or on the order of a dentist.

Device Story

Concentrix High-Speed Handpiece Series (MX, PX, FX, SX) are pneumatically driven, hand-held dental instruments. Devices utilize steel bearing turbines to perform dental procedures; MX model features manual chucking; PX, FX, and SX models feature push-button autochuck mechanisms. SX model includes fiber optics for use with type 3 swivel connectors; MX, PX, and FX are non-fiber optic with fixed backends. Operated by trained dental professionals in clinical settings to facilitate caries/amalgam removal, restorative work, and crown preparations. Output is mechanical rotation of dental burs for tissue/material removal. Benefit is efficient performance of standard dental restorative procedures.

Clinical Evidence

Bench testing only. No clinical data provided.

Technological Characteristics

Pneumatically driven hand-held dental handpieces. Materials: steel bearing turbines. Energy source: pneumatic (air-powered). Connectivity: fixed backend (MX, PX, FX) or type 3 swivel connector (SX). Fiber optics present in SX model. Lubrication required (Dentalube II).

Indications for Use

Indicated for use by trained dental professionals for dental procedures including caries and amalgam removal, restorative work, and crown preparations.

Regulatory Classification

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.

Predicate Devices

• Star Dental 430 Series High Speed Handpiece (K960719)

Reference Devices

• Dentalube II (K070869)

Submission Summary (Full Text)

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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: [phone] [phone] 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 Comparison<br>conclusion |
|-----------------------------------------------------|-------------------------------------------|
| 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 environment<br>and 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.

سخاري سيت

ルームなどなんて

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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 [phone] or [phone] 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