DIAGNODENT

K051909 · Kavo America · NBL · Oct 21, 2005 · Dental

Device Facts

• Record ID: K051909
• Device Name: DIAGNODENT
• Applicant: Kavo America
• Product Code: NBL · Dental
• Decision Date: Oct 21, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.1745
• Device Class: Class 2

Intended Use

For use as an aid in the diagnosis of dental caries.

Device Story

KaVo DIAGNOdent 2190 is a handheld laser fluorescence device for dental caries detection. It emits 650 nm laser light to illuminate tooth surfaces; detects fluorescence returned from tooth structure; processes signal to provide numeric and audible feedback via integrated LCD screen. Used by dentists in clinical settings to identify carious lesions. Compared to predicate DIAGNOdent 2095, the 2190 features a pen-like form factor with integrated probe, reduced laser power (Class I vs Class II), and single AA battery operation. Output assists clinicians in diagnostic decision-making regarding caries presence and severity.

Clinical Evidence

Substantial equivalence supported by bench, in vitro, and clinical studies, alongside EMC and electrical safety testing. No specific performance metrics (sensitivity/specificity) provided in the summary document.

Technological Characteristics

Laser fluorescence caries detection device. Emits 650 nm laser light (Class I, 190 nw max radiant power). Features integrated probe with sapphire tip. Powered by 1 AA alkaline battery. User interface includes LCD numeric display and audible tones. Sterilization via autoclave for probe tip.

Indications for Use

Indicated for use as an aid in the diagnosis of dental caries 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 (K983658)

Submission Summary (Full Text)

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# K051909

## 0CT 2 1 2005

### 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 July 11, 2005

- 1. Identification of the Device: Proprietary-Trade Name: KaVo DIAGNOdent® 2190 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, K983658.
- 3. Indications for Use (intended use): For use as an aid in the diagnosis of dental caries.
- 4. Description of the Device: This submission is for a modification of a device system cleared under K983658, the DIAGNOdent® 2095. The modification is in the form of a new method of packaging the device, in the form of a pen-like device instead of the former electronic unit with a fiber optic probe.

Image /page/0/Picture/7 description: The image shows two different DIAGNOdent devices. On the left is the Predicate DIAGNOdent 2095, which has a screen and a probe. On the right is the DIAGNOdent 2190, which is a handheld device with a screen. Both devices are used for dental diagnostics.

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

| Comparison<br>Areas | DIAGNOdent® 2095,<br>K983658 | DIAGNOdent® 2190 |
|-------------------------|--------------------------------------------------------|-----------------------------------------------------------------------------------|
| Indications<br>for use | For use as an aid in the<br>Diagnosis of Dental Caries | SAME |
| Probe<br>technology | Fiber Optic with sapphire<br>tip. | Probe is integrated into<br>the body of the hand held<br>unit, with sapphire tip. |
| Light Source | 655 nm <1 mw Laser | 650 nm, 190 nw<br>maximum average radiant<br>power |
| Laser<br>power<br>class | Class II | Class I |
| Returned<br>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<br>population | Dentists' offices | SAME |

- 6. Conclusion: In all important respects, the DIAGNOdent® 2190 is substantially equivalent to the DIAGNOdent® K983658. This conclusion is based on indications for use, bench, invitro, 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 logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes forming its wings, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circle around the eagle. The eagle is facing to the right. The logo is black and white.

Public Health Service

OCT 2 1 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

KAVO AMERICA C/O Daniel Kamm Regulatory Engineer Kamm & Associates P.O. Box 7007 Deer Field, Illinois 60015

Re: K051909

Trade/Device Name: DIAGNODENT Regulation Number: 21 CFR 872.1745 Regulation Name: Laser Fluorescence caries detection device Regulatory Class: II Product Code: NBL Dated: October 12, 2005 Received: October 13, 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 releveloca doors and have be 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 Amendinents, or to arrested Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general approvial applicions of the Act. The general controls provisions of the Act include controls provisions of a 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 11 your dovice is classified (See a siditional controls. Existing major regulations affecting (1 writ), it hay be do adjoco in the Code of Federal Regulations, Title 21, Parts 800 to 898. In your device tan as roublish 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 I least be auvrsou that 122 a determination that your device complies with other requirements modified in any Federal statutes and regulations administered by other Federal agencies. of the Act of ally I ederal bara suirements, including, but not limited to: registration 1 ou must comply with an also 120 cross and 801); good manufacturing practice and houng (21 OF RT rate 001), systems (QS) regulation (21 CFR Part 820); and if requirements us sectionic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

21 CFR 1000-1050.
This letter will allow you to begin marketing your device as described in your Section 510(k) This letter will and in your be rinding of substantial equivalence of your device to a premaired predicated. - I a 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), If you desire specific ad riod for your 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 may obtain of Small Manufacturers, International and Consumer Assistance at its toll-free Driber [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely vours,

Supti y. Michael Oms

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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## Indications for Use

510(k) Number (if known):_K051909

Device Name:__________________________________________________________________________________________________________________________________________________________________

Indications For Use:

For use as an aid in the diagnosis of dental caries.

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)

Susan Runpe

Suision Sign-Off) Olvision of Anesthesiology, General Hospital, Infection Control, Dental Devices

510(k) Number: K051105

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