DIAGNODENT PERIO TIP (ACCESSORY)

K042394 · Kavo America Corporation · NBL · Aug 2, 2005 · Dental

Device Facts

• Record ID: K042394
• Device Name: DIAGNODENT PERIO TIP (ACCESSORY)
• Applicant: Kavo America Corporation
• Product Code: NBL · Dental
• Decision Date: Aug 2, 2005
• Decision: SESE
• Submission Type: Traditional
• 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® Perio Tip is an accessory probe for the existing DIAGNOdent® system. It utilizes a 655 nm diode laser to induce fluorescence in subgingival dental calculus. The device is operated by dental professionals in a clinical setting. The probe tip is inserted subgingivally to scan the root surface; the system detects fluorescence emitted by calculus, which differs from the signal of healthy cementum. This signal is processed by the existing DIAGNOdent® electronics to provide an objective, reproducible indication of calculus presence. The output assists the clinician in identifying and localizing subgingival deposits, facilitating more accurate periodontal treatment and potentially improving patient outcomes by ensuring thorough cleaning of root surfaces.

Clinical Evidence

Evidence includes in-vitro and preclinical studies. Research (Folwaczny et al., 2002; Krause et al., 2003) demonstrated that 655 nm laser fluorescence is correlated with materials in calculi and concrements. Studies confirmed the method is reproducible and objective for assessing root surfaces, with highly significant differences in fluorescence intensity between cementum and calculus in air, electrolytic solution, and blood.

Technological Characteristics

Fiber optic probe tip; 655 nm <1 mW diode laser source; fluorescence-based sensing; autoclave sterilization for probe tip; connects to existing DIAGNOdent® electronics system.

Indications for Use

Indicated for use as an aid in the detection and localization of subgingival dental calculus in patients requiring periodontal assessment.

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® (K983658)
• DETECTAR (K023367)

Submission Summary (Full Text)

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AUG 2 - 2005

EXHIBIT 2 510(k) Summary KaVo America 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 Franz, President August 30, 2004

- 1. Identification of the Device: Proprietary-Trade Name: KaVo DIAGNOdent® Perio Tip Classification Name: Dental Hand Instrument, Laser Fluorescence Caries Detection Device, Product Codes EJB, NBL Common/Usual Name: Periodontal Probe
- Equivalent legally marketed device: DIAGNOdent® K983658 and DETECTAR, K023367 . 2.
- Indications for Use (intended use): For use as an aid in the detection and localization of 3. subgingival dental calculus.
- 4. Description of the Device: This submission is for a modification of a device system cleared under K983658, the DIAGNOdent®. The modification is in the form of a new accessory probe tip which can be connected to the unmodified DIAGNOdent® electronics system. The probe tip is longer and more slender to allow for the periodontal use. In-vitro and preclinical studies have shown that that laser fluorescence is correlated with materials in calculi and concrements 46. The researchers identified the method of subgingival calculi detection to be a reproducible, objective method for assessing the root surface". Although the intensity of the detection was influenced by surrounding media, the differences between cementum and calculus was highly significant in media like air, electrolytic solution and blood".

a. M. Folwaczny, R. Heym, A. Mehl and R. Hickel, "Subgingival Calculus detection with Fluorescence induced by 655 nm InGaAsP Diode Laser Radiation", J. Periodontol, June 2002, p 597-601

b. F. Krause, A. Braun, M. Frentzen, "The possibility of detecting subgingival calculus by laserfluorescence in vitro", Lasers Med. Sci. (2003) 18: 32-35

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K042394

- 5. Safety and Effectiveness, comparison to predicate device:

| Comparison<br>Areas | DIAGNOdent® K983658 | DETECTAR, K023367 | DIAGNOdent® Perio Tip |
|------------------------|----------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------|
| Indications<br>for use | Detection of Dental Caries | Detection of subgingival<br>dental calculus | Detection of subgingival<br>dental calculus |
| Probe<br>technology | Fiber Optic | SAME | SAME |
| Light Source | 655 nm <1 mw Laser | Two LEDs. The first is in<br>the red area of the visible<br>spectrum (RED-LED) and<br>shows a wavelength peak<br>at 635 in a band between<br>600 and 670nm. The<br>second LED is in the near<br>infrared spectrum (NIR-<br>LED) and shows a<br>wavelength peak at 880<br>nanometers in a band<br>between 800 and 900nm. | 655 nm <1 mw Laser |
| Returned<br>light | Fluorescence | Not specified.<br>(proprietary) | Fluorescence |
| Sterilization | Probe tip only, autoclave | SAME | SAME |
| Target<br>population | Dentists' offices | SAME | SAME |

- 6. Conclusion: In all important respects, the DIAGNOdent® Perio Tip is substantially equivalent to This conclusion is based on the DIAGNOdent® K983658 and DETECTAR, K023367. indications for use, in-vitro, and clinical studies.

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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health and Human Services (HHS). The seal features a stylized eagle with three lines representing its wings and body. The words "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle. The seal is black and white.

AUG 2 - 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Kavo America Corporation C/O Mr. Daniel Kamm Kamm & Associates P.O. Box 7007 Deerfield, Illinois 60015

Re: K042394

Trade/Device Name: DIANGOdent® Perio Tip Regulation Number: 21 CFR 872.1745 Regulation Name: Laser Fluorescence Caries Detection Device Regulatory Class: II Product Code: NBL Dated: July 27, 2005 Received: July 28, 2005

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 predicated 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.

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Page 2 - Mr. Kamm

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 (OS) 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 your 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/industry/support/index.html.

Sincerely yours,

Ours

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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K042394

## Indications for Use

510(k) Number (if known):

Device Name:__________________________________________________________________________________________________________________________________________________________________

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)

Suoer Rurse

(Division Sign-Off) Division of Anesthesiology, General Hospital, Infection Control, Dental Devic

510(k) Number: K02344

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