430 SWL 45 AND 430 SW 45 HIGH-SPEED HANDPIECES

K130455 · Dentalez Group, Stardental Division · EFB · Sep 25, 2013 · Dental

Device Facts

• Record ID: K130455
• Device Name: 430 SWL 45 AND 430 SW 45 HIGH-SPEED HANDPIECES
• Applicant: Dentalez Group, Stardental Division
• Product Code: EFB · Dental
• Decision Date: Sep 25, 2013
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.4200
• Device Class: Class 1
• Attributes: Therapeutic

Intended Use

The 430 SWL 45 and 430 SW 45 air-powered high speed handpieces are used by trained dental professionals for the removal of impacted third molars as well as endodontic and periodontal procedures for which a conventional handpiece would be used.

Device Story

Air-powered high-speed handpieces; 45-degree back-angled head design for improved access to posterior oral cavity. Operates via compressed air (30-34 PSI) to drive friction grip burs at ~400,000 RPM. Features include lubefree ceramic bearings, push-button autochuck turbine, and optional fiber optics. Used by dental professionals in clinical settings for surgical and restorative procedures. Side-venting exhaust directs air away from the bur work area. Benefits include enhanced access to third molars and efficient tissue/tooth removal.

Clinical Evidence

Bench testing only. Performance verified against internal specifications and standards including ISO 7785-1. Sterilization and dry time validation performed per ANSI/AAMI ST79:2010 and AAMI/ANSI/ISO 14937:2009. Risk analysis conducted per ISO 14971:2009.

Technological Characteristics

Air-driven, handheld dental handpiece. Materials: ceramic bearings, lubefree turbine. 45-degree back-angled head. Fiber optic (430 SWL 45) or non-fiber optic (430 SW 45). Swivel connector. Friction grip bur interface (ISO 1797-1). Energy: pneumatic (30-34 PSI). Sterilization: validated per AAMI/ISO standards.

Indications for Use

Indicated for use by trained dental professionals for removal of impacted third molars, endodontic procedures, and periodontal procedures.

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

• 430 Series High-Speed Handpiece (K960719)
• Ti-Max X450 (K112024)
• Impact Air 45 Handpiece for Endodontic Use (K972375)

Submission Summary (Full Text)

{0}------------------------------------------------

KIBOYSS

DentalEZ, Inc. StarDental Division 510(k) Premarket Notification 430 SWL 45 and 430 SW 45 High-Speed Handpieces

#### Section 5

510(k) Summary

## Section 5: 510(k) Summary

Date prepared: March 7, 2013

## 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] Fax: [phone]

### Proprietary/Trade Name:

430 SWL 45 and 430 SW 45 High-Speed Handpieces

#### Classification:

Handpiece, Air-powered, Dental (21 C.F.R. § 872.4200, Product code EFB)

### Predicate Device:

430 Series High-Speed Handpiece (K960719) manufactured by StarDental

Ti-Max X450 (K112024) manufactured by Nakanishi, Inc.

Impact Air 45 Handpiece for Endodontic Use (K972375) manufactured by Palisades Dental.

The StarDental 430 SWL 45 and 430 SW 45 High-Speed Handpieces have a similar intended use as the predicate Ti-Max X 450 and Impact Air 45 handpieces. The StarDental 430 SWL 45 and 430 SW 45 High-Speed Handpieces incorporates most of the features of the StarDental 430 Series High-Speed Handpiece, however, the intended use of the proposed device has changed to include removal of impacted third molars, endodontic and periodontal procedures.

{1}------------------------------------------------

The methods of operation and technology in the proposed devices are similar to all the predicate devices listed above.

### Device Description:

The 430 SWL 45 and 430 SW 45 air-powered high speed handpieces are used by trained dental professionals for the removal of impacted third molars as well as endodontic and periodontal procedures for which a conventional handpiece would be used.

The 430 SWL 45 and 430 SW 45 High-Speed Handpieces are designed with a 45 degree back angled head to facilitate access to the back of the oral cavity. They are designed so that air that expelled from the head of the handpiece is directed out the side of the handpiece head and not directed onto the work area of the bur. The handpieces are intended for use with a friction grip bur that conforms to ISO 1797-1 standards. Recommended air pressure is 30-34 PSI which results in a bur rotation of approximately 400,000 RPM.

The 430 SWL 45 High-Speed Handpiece is a fiber optic, swivel connector type handpiece with a lubefree, ceramic bearing, push button autochuck turbine. The 430 SW 45 High-Speed Handpiece is a non-fiber optic version of the 430 SWL 45 Handpiece.

### Intended Use:

The 430 SWL 45 and 430 SW 45 air-powered high speed handpieces are used by trained dental professionals for the removal of impacted third molars as well as endodontic and periodontal procedures for which a conventional handpiece would be used

### Technological Characteristics:

The 430 SWL 45 and 430 SW 45 High-Speed Handpieces are air-driven, handheld devices which have similar technological characteristics to the predicate devices. The proposed devices are swivel connector type handpieces. They incorporate a lubefree, ceramic bearing, push button autochuck turbine assembly. The 430 SWL 45 High-Speed Handpiece is a fiber optic handpiece while the 430 SW 45 is non-fiber optic.

The proposed devices incorporate a 45 degree back angled head to allow for easier access to the third molar which is same as the Ti-Max X450 and Impact Air 45 handpieces.

{2}------------------------------------------------

The following table summarizes the comparison of the 430 SWL 45 and 430 SW 45 High-Speed Handpieces to the predicate devices for various technological characteristics.

| Technological Characteristics | Predicate Device Comparison<br>conclusion |
|-----------------------------------------------------|-------------------------------------------|
| Indication for use | Similar |
| Target population | Identical |
| Design | Similar |
| Materials | Identical |
| 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 |

### Non-clinical data:

The 430 SWL 45 and 430 SW 45 High-Speed Handpieces were developed taking into consideration all applicable technical standards, internal specifications and FDA guidance documents. The handpieces conformance with the applicable international and internal standards was verified through bench testing.

TR 468 was developed internally to determine the performance characteristics of the 430 SWL 45 and 430 SW 45 High-Speed Handpieces taking into consideration StarDental internal specifications and ISO 7785-1, 1997-08-01.

TR 470 was developed internally to determine the effectiveness of the housing pressure relief slots and vortex washer on the 430 SWL 45 and 430 SW 45 High-Speed Handpieces. This test request also compared the proposed devices with the predicate devices in order to quantify the air bleed of the handpiece head.

HIGHPOWER Validation Testing & Lab Services of Rochester, NY was contracted to perform sterilization validation and dry time validation studies for the proposed handpieces. These studies were performed in accordance to ANSI/AAMI ST79:2010 & A1:2010 & A2:2011 and AAMI/ANSI/ISO 14937:2009.

{3}------------------------------------------------

A risk analysis for the 430 SWL 45 and 430 SW 45 High-Speed Handpieces was developed using ISO14971:2009.

# Substantial Equivalence:

The determination of substantial equivalence is based on the premise that the proposed device and the predicate devices have similarities in intended use, principles of operation, and functional design.

While the intended use of the proposed device and the 430 Series High Speed Handpiece are different, these differences do not raise any new questions of safety · or effectiveness and are thus considered substantially equivalent.

{4}------------------------------------------------

Image /page/4/Picture/0 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three stripes representing the department's mission. The eagle is encircled by the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement. The logo is simple and uses a black and white color scheme.

#### DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring MD 20993-0002

#### September 25, 2013

DentalEZ Incorporated, StarDental Division Mr. Jim Watkins Engineering/Quality Manager 1816 Colonial Village Lane LANCASTER, PA 17601

Re: K130455

Trade/Device Name: 430 SWL 45 and 430 SW 45 High-Speed Handpicces Regulation Number: 21 CFR 872.4200 Regulation Name: Dental Handpiece and Accessories Regulatory Class: I Product Codc: EFB Dated: August 23, 2013 Received: August 27, 2013

#### 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 Amendments, or 10 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. Insting of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH docs 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.

{5}------------------------------------------------

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 contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Richard C.
Chapman for

Kwame Ulmer M.S. Acting Division Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{6}------------------------------------------------

Indications for Use

510(k) Number (if known): K130455

··············································································································································································

Device Name: 430 SWL 45 and 430 SW 45 High-Speed Handpieces

Indications for Use:

The 430 SWL 45 and 430 SW 45 air-powered high speed handpieces are used by trained dental professionals for the removal of impacted third molars as well as endodontic and periodontal procedures for which a conventional handpiece would be used.

Prescription Use ਮ (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)

| Andrew I. Steen -S | 2013.09.25 09:05:37-04'00' |
|--------------------|----------------------------|
|--------------------|----------------------------|

| (Division Sign-Off) | Page 1 of 1 |
|----------------------------------------------|-------------|
| Division of Anesthesiology, General Hospital | |
| Infection Control, Dental Devices | |

| 510(k) Number: | K130455 |
|----------------|---------|
|----------------|---------|