INSIGHT ULTRASONIC INSERTS

K092417 · Discus Dental, LLC · ELC · Dec 11, 2009 · Dental

Device Facts

• Record ID: K092417
• Device Name: INSIGHT ULTRASONIC INSERTS
• Applicant: Discus Dental, LLC
• Product Code: ELC · Dental
• Decision Date: Dec 11, 2009
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.4850
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Insight Ultrasonic Insert is designed to be used in the handpiece of any conventional magnetostrictive ultrasonic scaler, an instrument used for dental cleaning and removal of tenacious calculus and plaque using ultrasonic vibration. The last 4.3 mm of the insert tip vibrates ultrasonically to remove the tenacious calculus from the teeth.

Device Story

Insight Ultrasonic Inserts are dental instruments designed for use with conventional magnetostrictive ultrasonic scaler handpieces. The device consists of a metal tip and a stack; when inserted into a handpiece, it responds to a varying magnetic field generated by the handpiece's copper wiring. This magnetic field induces expansion and contraction of the metal stack, causing the insert tip to vibrate in an elliptical motion at frequencies of 25,000 to 30,000 Hz. An integrated water supply cools the tip and flushes debris. Used by dental professionals for the removal of tenacious calculus and plaque, the device facilitates dental cleaning. The mechanical vibration of the distal 4.3 mm of the tip performs the instrumentation, benefiting the patient by enabling efficient removal of dental deposits.

Clinical Evidence

bench testing only

Technological Characteristics

Magnetostrictive ultrasonic scaler insert; operates at 25,000 to 30,000 Hz; elliptical vibration pattern; integrated water cooling; 20 tip styles; 6 color variations; distal 4.3 mm active tip length.

Indications for Use

Indicated for dental cleaning and removal of tenacious calculus and plaque from teeth using ultrasonic vibration in a clinical setting.

Regulatory Classification

Identification

An ultrasonic scaler is a device intended for use during dental cleaning and periodontal (gum) therapy to remove calculus deposits from teeth by application of an ultrasonic vibrating scaler tip to the teeth.

Predicate Devices

• Protégé Ultrasonic Inserts (K051776)
• Ultrasonic Scaler Inserts (K953919)
• Satin Swivel Ultrasonic Inserts (K012060)

Submission Summary (Full Text)

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

KO92412

# DEC 1 1 2009

### B. Summary of Safetv and Effectiveness

Insight Ultrasonic Inserts

- 1. Date of Summary Preparation:
July 23, 2009

- 2. Submitting Firm:
Discus Dental, LLC.

3. Contact Person

4.

Winkie Wong Associate, Regulatory Affairs Discus Dental, LLC. 8550 Higuera Street Culver City, CA 90232 310.845.8339 310.845.8647 - fax

Name of Medical Device Proprietary Name:

Insight Ultrasonic Inserts

Common/Usual Name: Ultrasonic Inserts

Classification Name:

Scaler, Ultrasonic

### న. Description of Medical Device

The Insight Ultrasonic Insert is designed to be used in the handpiece of any conventional magnetostrictive ultrasonic scaler, an instrument used to remove tenacious calculus and plaque by ultrasonic vibrations. When place inside the handpiece, the ultrasonic insert is exposed to a varying magnetic field created by a unique pattern of copper wiring wrapping the plug of the handpiece. The varying magnetic field causes the insert "stack" of the metal tips to contract and expand, thus resulting in insert tip vibration in an elliptical motion. The water supply in the insert washes away the debris and cools the insert tip. The distal 4.3 mm portion of the insert tip is affected by the frequency of 25,000 to 30,000 Hz and The tips are offered in two frequencies, six performs the instrumentation. different colors and twenty different tip styles.

#### Intended Use 6.

The Insight Ultrasonic Insert is designed to be used in the handpiece of any conventional magnetostrictive ultrasonic scaler, an instrument used for dental cleaning and removal of tenacious calculus and plaque using ultrasonic vibration. The last 4.3 mm of the insert tip vibrates ultrasonically to remove the tenacious calculus from the teeth.

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

### Substantial Equivalence Determination 7.

:

:

.

.

:

1. 1

:

. . . . .

.

:

.

.

· .

. .

Discus Dental, LLC. believes that the Insight Ultrasonic Inserts are substantially equivalent to the following commercially marketed ultrasonic inserts:

| Predicate Device | Company | 510(k) No. |
|---------------------------------|--------------------------|------------|
| Protégé Ultrasonic Inserts | Discus Dental | K051776 |
| Ultrasonic Scaler Inserts | Hu-Friedy MFG. CO., Inc. | K953919 |
| Satin Swivel Ultrasonic Inserts | Hu-Friedy MFG. CO., Inc. | K012060 |

# END OF SUMMARY OF SAFETY AND EFFECTIVENESS

.

.

:

:

.

:

: :

・

.

.

,

. . .

:

:

:

נ

.

.

100 - 100 - 100

. .

・

Discus Dental, LLC.

B-2

### CONFIDENTIAL

: .

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

# DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/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" around the perimeter. Inside the circle is a stylized symbol that resembles a caduceus, a symbol often associated with healthcare, but in this case, it is a modern interpretation of the symbol.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-O66-0609 Silver Spring, MD 20993-0002

Mr. Winkie Wong Regulatory Affairs Associate Regulatory Affairs Discus Dental, LLC 8550 Higuera Street Culver City, California 90232

DEC 1 1 2009

Re: K092417

Trade/Device Name: Insight Ultrasonic Inserts Regulation Number: 872.4850 Regulation Name: Ultrasonic Scaler Regulatory Class: II Product Code: ELC Dated: . December 8, 2009 Received: December 10, 2009

Dear Mr. Wong:

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 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. Wong

バ

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.html fart 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.

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Susan Runnes

2 Anthony D. Watson, BS, MS, MBA Director

Division of Anesthesiology, General Hospital, Infection Control, and Dental Devices Office of Device Evaluation

Center for Devices and

Radiological Health

Enclosure

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

#### E. Indications for Use Statement

**510(k) Number:** K092417

Device Name: Insight Ultrasonic Inserts

## Intended Use

The Insight Ultrasonic Insert is designed to be used in the handpiece of any conventional magnetostrictive ultrasonic scaler, an instrument used for dental cleaning and removal of tenacious calculus and plaque using ultrasonic vibration. The last 4.3 mm of the insert tip vibrates ultrasonically to remove the tenacious calculus from the teeth.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use - X Per 21 CFR Sections 801.109)

OR Over-The-Counter Use
Susan Runyon

(Division Sign-Of) Division of Anesthesiology. General Hospital Infection Control, Dental Devices

**510(k) Number:** ***_***

Discus Dental, LLC.

E - 1

### CONFIDENTIAL