SOLARA SERIES COMPRISED OF THE SOLARA HIGH SPEED DENTAL HANDPIECE AND THE SOLARA PLUS HIGH SPEED DENTAL HANDPIECE

K030133 · Dentalez Group · EBF · Apr 29, 2003 · Dental

Device Facts

• Record ID: K030133
• Device Name: SOLARA SERIES COMPRISED OF THE SOLARA HIGH SPEED DENTAL HANDPIECE AND THE SOLARA PLUS HIGH SPEED DENTAL HANDPIECE
• Applicant: Dentalez Group
• Product Code: EBF · Dental
• Decision Date: Apr 29, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3690
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Solara Series High Speed Dental Handpieces are pneumatically driven, handheld devices intended for use by trained dental professionals for drilling in the oral cavity. Procedures include but not limited caries removal, restorative work and crown preparations.

Device Story

Solara Series High Speed Dental Handpieces are pneumatically driven, handheld instruments used by dental professionals in clinical settings. The devices function as rotary tools for drilling, caries removal, restorative work, and crown preparations within the oral cavity. They operate via pneumatic power to drive a bur for tooth structure removal. The device is used by dentists or trained staff to perform standard dental procedures. The output is the mechanical action of the bur, which allows the clinician to remove decay or shape teeth for restorations, directly facilitating dental treatment and patient oral health maintenance.

Clinical Evidence

Bench testing only.

Technological Characteristics

Pneumatically driven, handheld dental handpiece. Operates via air pressure to rotate a bur. Designed for intraoral use. Class I device under 21 CFR 872.4200.

Indications for Use

Indicated for use by trained dental professionals for intraoral drilling and preparation of dental cavities for restoration, such as fillings.

Regulatory Classification

Identification

Tooth shade resin material is a device composed of materials such as bisphenol-A glycidyl methacrylate (Bis-GMA) intended to restore carious lesions or structural defects in teeth.

Predicate Devices

• StarDental 430 Series High Speed Handpiece (K960719)
• StarDental 430 Series High Speed Handpiece (K982593)
• NSK TI-Max Titanium Handpiece

Submission Summary (Full Text)

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

# K030133

Image /page/0/Picture/1 description: The image shows the logo for DentalEZ Group. The text "DentalEZ" is in a bold, sans-serif font, with "GROUP" in a smaller font size underneath. A stylized graphic of a partial circle is to the right of the text.

APR 2 9 2003

Star Dental Products 1816 Colonial Village Lane Lancaster, PA 17601-5864 717/291-1161 Fax [phone] www.dentalez.com

# 510(k) Summary Solara Series High Speed Dental Handpieces January 10, 2003

# Company:

StarDental, Div. DentalEz Inc. Owner/operator number 2520265

# Contact Person:

William Guscott Engineering Manager StarDental, Div. DentalEz Inc. 1816 Colonial Village Lane Lancaster, PA 17601 Phone: [phone], ext. 4319 [phone] Fax:

# Proprietary/Trade Name:

Solara Series High Speed Dental Handpieces, which includes Solara High Speed Dental Handpiece and Solara Plus High Speed Dental Handpiece

### Common/Usual Name:

Dental Handpiece

#### Classification:

Dental handpiece and accessories (per 21 CFR 872.4200)

#### Predicate Device:

StarDental 430 Series High Speed Handpiece (K960719 and K 982593) NSK TI-Max Titanium Handpiece

Image /page/0/Picture/17 description: The image contains the logo for StarDental. The text "StarDental" is written in a bold, italicized font. To the right of the text is a stylized star symbol.

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

# Device Description/Intended Use:

The Solara Series High Speed Dental Handpieces are pneumatically driven, handheld devices intended for use by trained dental professionals for drilling in the oral cavity. Procedures include but not limited caries removal, restorative work and crown preparations.

# Substantial Equivalence:

The determination of substantial equivalence is based on the premise that the proposed device and the predicate devices have the same intended use, similar technology and design. Both devices have the same means of operation and are used for the same procedures. Improvements made to the proposed device were initiated to improve the handpiece performance while maintaining the safety of the device.

Image /page/1/Picture/4 description: The image shows the word "StarDental" in a bold, sans-serif font. The word is all in lowercase except for the "S" and "D". To the right of the word is a stylized star shape. The star is black and has a curved design.

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

Image /page/2/Picture/1 description: The image is a black and white seal for the Department of Health & Human Services - USA. The seal is circular with text around the perimeter. Inside the circle is a stylized image of an eagle with three stripes above it.

Public Health Service

APR 2 9 2003

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. William Guscott Engineering Manager DentalEZ, Incorporated Star Dental Products Division 1816 Colonial Village Lane Lancaster, Pennsylvania 17601-5864

Re: K030133

Trade/Device Name: Solara Series Comprised of the Solara High Speed Dental Handpiece and the Solara Plus High Speed Dental Handpiece Regulation Number: 21 CFR 872.4200 Regulation Name: Dental Handpiece and Accessories Regulatory Class: I Product Code: EBF Dated: April 7, 2003 Received: April 9, 2003

Dear Mr. Guscott:

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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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.

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

Page 2 - Mr. Guscott

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): 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.

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits vour device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at [phone]. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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/cdrh/dsma/dsmamain.html

Sincerely vours.

Siva Kumar

Susan Runner, DDS, MA Interim Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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

of_1 Page |

K030133 510(k) Number (if known):

Device Name: Solara Series Comprised of the Solara High Speed Dental Handpiece and the Solara
-----------------------------------------------

Indications For Use:

High speed handpieces are used intraorally by trained dental professionals for drilling and preparation of dental cavities for restoration, such as fillings. The intended use of this device is identical to the predicate 430 series handpiece currently marketed under 510(k) numbers K960719 and K982593.

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Optional Format 3-10-98)

Robert S. Betz DDS for Dr. K.P. Mulvey

510(k) Number: K030133