DIAGNODENT 2190 WITH PERIODONTAL PROBE

K060080 · Kavo Dental Corporation · NTK · Feb 8, 2006 · Dental

Device Facts

• Record ID: K060080
• Device Name: DIAGNODENT 2190 WITH PERIODONTAL PROBE
• Applicant: Kavo Dental Corporation
• Product Code: NTK · Dental
• Decision Date: Feb 8, 2006
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 872.1745
• Device Class: Class 2

Intended Use

For use as an aid in the detection and localization of subgingival dental calculus.

Device Story

The KaVo DIAGNOdent 2190 is a handheld laser fluorescence device used by dentists to detect and localize subgingival dental calculus. The device utilizes a 655 nm laser light source to illuminate the target area; the presence of calculus is determined by measuring the fluorescence of the returned light. The device features an integrated sapphire-tipped probe and provides feedback to the clinician via an LCD display and audible tones. It is a modification of the predicate DIAGNOdent Pen, integrating the periodontal probe directly into the handheld unit. The device is intended for professional use in dental offices to assist in clinical decision-making regarding periodontal health.

Clinical Evidence

The submission relies on bench, in-vitro, and clinical studies, alongside EMC and electrical safety testing, to demonstrate substantial equivalence to the predicate devices.

Technological Characteristics

Laser fluorescence detection; 655 nm Class I laser; sapphire-tipped probe integrated into handheld unit; LCD user interface; powered by 1 AA alkaline battery; probe tip is autoclavable.

Indications for Use

Indicated for use as an aid in the detection and localization of subgingival dental calculus in dental office settings.

Regulatory Classification

Identification

A laser fluorescence caries detection device is a laser, a fluorescence detector housed in a dental handpiece, and a control console that performs device calibration, as well as variable tone emitting and fluorescence measurement functions. The intended use of the device is to aid in the detection of tooth decay by measuring increased laser induced fluorescence.

Special Controls

*Classification.* Class II, subject to the following special controls:(1) Sale, distribution, and use of this device are restricted to prescription use in accordance with § 801.109 of this chapter; (2) Premarket notifications must include clinical studies, or other relevant information, that demonstrates that the device aids in the detection of tooth decay by measuring increased laser induced fluorescence; and (3) The labeling must include detailed use instructions with precautions that urge users to: (i) Read and understand all directions before using the device, (ii) Store probe tips under proper conditions, (iii) Properly sterilize the emitter-detector handpick before each use, and (iv) Properly maintain and handle the instrument in the specified manner and condition.

Predicate Devices

• DIAGNOdent® 2095 (K042394)
• Diagnodent Pen (K051909)

Submission Summary (Full Text)

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K0600080

FEB 8 2006

EXHIBIT 2 510(k) Summary KaVo Dental Corporation 340 East Main Street Lake Zurich, Illinois 60047 Toll Free: 800 323 8029 Tel: 847 / 550 - 6800 Fax: 847 / 550 - 6825 e-mail: [e-mail] Contact: John Miller, Director of RA/QA December 26, 2005

- 1. Identification of the Device: Proprietary-Trade Name: KaVo DIAGNOdent® 2190 with periodontal probe Classification Name: Dental Hand Instrument, Laser Fluorescence Caries Detection Device, Product Codes NTK Common/Usual Name: Laser fluorescence caries detection device
- 2. Equivalent legally marketed device: DIAGNOdent® 2095, K042394 AND Diagnodent Pen, K051909.
- 3. Indications for Use (intended use): For use as an aid in the detection and localization of subgingival dental calculus.
- 4. Description of the Device: This submission is for a modification of a device system cleared under K042394, the DIAGNOdent® 2095 with periodontal probe, and Diagnodent Pen, K051909. The modification is in the form of adding a periodontal probe to the Diagnodent Pen product.

Image /page/0/Figure/7 description: The image shows two different DIAGNOdent periodontal probes. The first probe is the DIAGNOdent 2095 Periodontal Probe (K042394), and the second probe is the DIAGNOdent 2190 Periodontal Probe. Both probes have two parts labeled as "Part 1" and "Part 2".

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p.2 KD60080

| Comparison Areas | DIAGNOdent® 2095<br>With periodontal probe, K042394 | DIAGNOdent® 2190<br>With periodontal probe |
|---------------------|-------------------------------------------------------------------------------------|-----------------------------------------------------------------------------|
| Indications for use | For use as an aid in the detection and localization of subgingival dental calculus. | SAME |
| Probe technology | Fiber Optic with sapphire tip. | Probe is integrated into the body of the hand held unit, with sapphire tip. |
| Construction | Base unit with fiber optic detachable probes | Hand held unit with detachable probe tips |
| Light Source | 655 nm <1 mw Laser | SAME |
| Laser power class | Class II | Class I |
| Returned light | Fluorescence | Fluorescence |
| Sterilization | Probe tip only, autoclave | SAME |
| User interface | Numeric and audible tones<br>LED numbers | SAME except<br>LCD numbers |
| Power source | 6- AA Alkaline battery | 1- AA Alkaline battery |
| Target population | Dentists' offices | SAME |

- 5. Safety and Effectiveness, comparison to predicate device:
- 6. Conclusion: In all important respects, the DIAGNOdent® 2190 with periodontal probe is substantially equivalent to the DIAGNOdent® K042394. This conclusion is based on indications for use, bench, in-vitro, and clinical studies, as well as EMC and electrical safety testing.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the seal of the Department of Health and Human Services (HHS) of the United States. The seal features an abstract image of an eagle with three heads, symbolizing service to the people. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA" is arranged in a circular pattern around the eagle emblem. The seal is presented in black and white.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB 8 2006

KaVo Dental Corporation C/O Mr. Danial Kamm Regulatory Engineer Kamm & Associates P.O. Box 7007 Deerfield, Illinois 60015

Re: K060080

Trade/Device Name: DIAGNOdent® 2190 with Periodontal Probe Regulation Number: 872.1745 Regulation Name: Laser Fluorescence Caries Detection Device Regulatory Class: II Product Code: NTK Dated: January 10, 2006 Received: January 10, 2006

Dear Mr. Kamm:

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 vour 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. Kamm

Please be advised that FDA's issuance of a substantial equivalence determination does not Please be auvised that I DA s issualled on that your device complies with other requirements Incall that FDA nas muce a december and regulations administered by other Federal agencies. of the Act of ally receitar statutes and regulations. but not limited to: registration You must comply with an the Fict of tot 8 104 21 CFR Part 801); good manufacturing practice alla listing (21 CFR Part 067), advailing (21 CFR Part 820); and if requirents as set form in the quality systems (Sections (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) This letter will anow you to begin mational your substantial equivalence of your device to a premarket notification. - The PDF Intaling or colassification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), II you desire specific advice for your de research as a more and the regulation and any and 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 may obtain of Small Manufacturers, International and Consumer Assistance at its toll-free Dribber [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Syvette H. Michaud, Dmd.

Chiu Lin, Ph.D. 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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K060080

Indications for Use

510(k) Number (if known):

Device Name: __________ DIAGNOdent® 2190 with Periodontal Probe

Indications For Use:

For use as an aid in the detection and localization of subgingival dental calculus.

Prescription Use _X (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Suser Russe

A.C.A., Local Issues

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