INSPEKTOR PRO

K040063 · Inspektor Dental Care BV · NBL · Jun 24, 2004 · Dental

Device Facts

• Record ID: K040063
• Device Name: INSPEKTOR PRO
• Applicant: Inspektor Dental Care BV
• Product Code: NBL · Dental
• Decision Date: Jun 24, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.1745
• Device Class: Class 2

Intended Use

The Inspektor™ Pro is intended to be used as an aid in the diagnosis of dental caries.

Device Story

Inspektor™ Pro is a dental fluorescence examination system used by dental professionals in clinical settings. The system comprises a handpiece, systembox, computer, monitor, and footswitch. It utilizes fluorescence technology to detect dental caries; the device captures optical signals from the tooth surface, which are processed by the integrated computer system to provide visual or quantitative feedback to the clinician. This output assists the dentist in identifying carious lesions, facilitating clinical decision-making regarding treatment. The device is intended to improve diagnostic accuracy for dental caries.

Technological Characteristics

System includes a handpiece, systembox, computer, monitor, mouse, keyboard, and footswitch. Operates via fluorescence detection of dental caries. Class II device (Product Code: NBL).

Indications for Use

Indicated for use as an aid in the diagnosis of dental caries in patients requiring dental examination.

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

• KaVo DIAGNOdent (K983658)

Submission Summary (Full Text)

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JUN 2 4 2004

Image /page/0/Picture/1 description: The image shows the logo for Inspektor Dental Care. The logo consists of a right-pointing arrow followed by the word "INSPEKTOR" in bold, sans-serif font. Below "INSPEKTOR" is the phrase "DENTAL CARE" in a smaller, sans-serif font. The arrow is a simple line drawing with a triangular head.

K040063

Head Office Pieter Baststraat 21-27 1071 TV Amsterdam The Netherlands T. [phone] F. [phone] E. [e-mail]

#### Development & production

Quellijnstraat 92 1072 XX Amsterdam T. [phone] F. [phone]

# 510(k) Summary

# 4.1. Applicant

| Name | Inspektor Dental Care bv | |
|---------------------|-----------------------------|--|
| Address | (Head office) | |
| | Pieter Baststraat 21-27 | |
| | 1071 TV Amsterdam | |
| Telephone | [phone] | |
| Fax | [phone] | |
| e-mail | [e-mail] | |
| Establishment | | |
| Registration number | not available | |
| Contact Person | Elbert Waller | |
| Address | Inspektor Dental Care bv | |
| | (Development & Production) | |
| | Quellijnstraat 92 | |
| | 1072 XX Amsterdam | |
| | Netherlands | |
| Telephone | [phone] | |
| Fax | [phone] | |
| e-mail | [e-mail] | |

## 4.2. Date summary prepared

June 17, 2004

c-mail

## 4.3. Name of the Device

: Inspektor™ Pro Proprietary/trade name : Dental Fluorescence Examination Device Common name : K040064 510(k) Number

4.4. Predicate Devices: KaVo DIAGNOdent, K983658

## 4.5. Device description

The Inspektor™ Pro consists of a systembox equipped with a handpiece, mounted in a\trolley together with a computer, a monitor, mouse, keyboard and footswitch.

Chamber of commerce Amsterdam 341 92 359

Van Lanschot banking 63.25.62.95 VAT NL 812 444 231 B01

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#### 4.6. Intended Use

The Inspektor™ Pro is intended to be used as an aid in the diagnosis of dental caries.

#### 4.7. Indications for use

The Inspektor™ Pro is indicated as an aid in the diagnosis of dental caries.

### 4.8. Substantial Equivalence

Inspektor™ Pro resembles the predicate device DIAGNOdent as an aid in the diagnosis of dental caries.

I hereby declare that the information stated in this 510(k) summary is truthful and accurate.

Date June 17, 2004

Place Amsterdam

Signature:

Elbert Waller

Elbert V er (CDO Inspektor Dental Čare BV)

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three curved lines representing wings and a stylized tail.

#### Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN 2 4 2004

Inspektor Dental Care BV Mr. Elbert Waller (Development & Production) Quellijnstraat 92 1072 XX Amsterdam NETHERLANDS

Re: K040063

Trade/Device Name: Inspektor™ Pro Regulation Number: 872.1745 Regulation Name: Laser Fluorescence Caries Detection Device Regulatory Class: II Product Code: NBL Dated: April 8, 2004 Received: April 13, 2004

Dear Mr. Waller:

We have reviewed your Section 510(k) premarket notification of intent to market the device we have rother 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 Interstate conments of press that have been reclassified in accordance with the provisions of Amendinens, or to do roug, 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 approvin apprevisions of the Act. The general controls provisions of the Act include controls provisions or al 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 (1 Mr), it may of each be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In your device early of ther announcements concerning your device in the Federal Register.

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Page 2 - Mr. Waller

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 mount that I Dr may Federal statutes and regulations administered by other Federal agencies. or the rice of all , outh all the Act's requirements, including, but not limited to: registration 1 od into comply with 807); labeling (21 CFR Part 801); good manufacturing practice and listing (21 CF read vir the quality systems (QS) regulation (21 CFR Part 820); and if requirements as 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) This letter will and A yourse of substantial equivalence of your device to a premarket notification - I s 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 may obtain other gManufacturers, 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 yours,

Ques

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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# INDICATION FOR USE STATEMENT

510(k) Number: K040063

Device Name: Inspektor™ Pro

Indications for use: The Inspektor™ Pro is indicated as an aid in the diagnosis of dental caries.

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

Concurrence of CDHR, Office of Device Evaluation (ODE)

| Prescription use | X | OR (Per 21 CFR 801.109) | Over-The-Counter Use _____ |
|------------------|---|-------------------------|----------------------------|
|------------------|---|-------------------------|----------------------------|

(Optional format 1-2-9)

| | <center>(Division Sign-Off)</center> Division of Anesthesiology, General Hospital, Infection Control, Dental Devices |
|--|----------------------------------------------------------------------------------------------------------------------------------|
|--|----------------------------------------------------------------------------------------------------------------------------------|

| 1602.510kAIR.02-02.doc | 510(k) Number: R040063 | 2-1 |
|------------------------|------------------------|-----|
|------------------------|------------------------|-----|