D-CARIE, MODEL N121-M1

K043156 · Neks Technologies, Inc. · NBL · Apr 28, 2005 · Dental

Device Facts

• Record ID: K043156
• Device Name: D-CARIE, MODEL N121-M1
• Applicant: Neks Technologies, Inc.
• Product Code: NBL · Dental
• Decision Date: Apr 28, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.1745
• Device Class: Class 2

Intended Use

D-Carie is indicated for aiding in the diagnosis of dental carries

Device Story

D-CARIE is a dental diagnostic aid; utilizes optical fiber probe to read optical signatures of suspicious dental areas; converts optical input into electrical signals; computer analysis identifies areas requiring further examination; used by dental professionals in clinical settings; provides objective data to assist clinicians in caries detection; supplements traditional visual/tactile examination; benefits patients through earlier or more accurate identification of dental decay.

Clinical Evidence

Evidence includes two in vitro and one in vivo evaluation comparing D-CARIE to the DIAGNOdent, plus one additional in vitro study on 'special situations'. Studies conducted by experienced clinicians. Results indicated D-CARIE is equivalent to the predicate DIAGNOdent device.

Technological Characteristics

Optical fiber probe for signal acquisition; signal conversion to electrical output; computer-based analysis; form factor similar to DIAGNOdent probe tip; Class II device (Product Code NBL).

Indications for Use

Indicated for aiding 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

• Detectar System (K023367)
• DIAGNOdent Laser Fluorescence Caries Detection Device (K983658)
• Alpha 4 LS Automated Microtiterplate Processor (K973638)
• Dental explorers [510(k) exempt]

Submission Summary (Full Text)

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K043156

## 510(k) Summary

APR 2 8 2005

NEKS Technologies 1. Name/Address of Submitter : 230, Bernard-Belleau, Bureau 221 Laval, Quebec H7V 4A9 Canada

2. Contact Person :

Nathalie H. Tremblay President and CEO Phone : [phone] Fax : [phone]

- April 19, 2005 3. Date Summary Prepared :
- D-CARIE 4. Device Name :

5. Predicate Devices :

Detectar System (K023367) DIAGNOdent Laser Fluorescence Caries Detection Device (K983658) Alpha 4 LS Automated Microtiterplate Processor (K973638) Dental explorers [510(k) exempt]

- 6. Device Description and Intended Use :
Similar to the Diagnodent the D-CARIE is indicated for use in aiding in the diagnosis of dental caries. The D-CARIE probe is similar in intended use, size, and shape to a Diagnodent probe tip. Identical to the technology in the Detectar the D-CARIE probe contains an optical fiber that reads the optical signature of suspicious areas and converts it into an electrical signal. From that electrical signal a computer analysis identifies areas that need further examination.

- 7. Brief Description of Clinical and Non-clinical Testings :
Two in vitro and one in vivo evaluations comparing the D-CARIE with a Diagnodent were conducted by experienced clinicians. Moreover a third in vitro evaluation was conducted to examine the quality of detection on "special situations". In these tests, the D-CARIE was found equivalent to Diagnodent.

- Substantially equivalent to the cited predicate devices. 8. Conclusion Drawn :

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/1/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 text "DEPARTMENT OF HEALTH AND HUMAN SERVICES . USA" around the perimeter. Inside the circle is a stylized symbol that resembles a caduceus, with three abstract shapes that could be interpreted as snakes or flowing lines.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

APR 2 8 2005

ﻴﻴ

NEKS Technologies, Incorporated C/O Mr. Charles H. Kyper Regulatory Affairs Consultant Kyper & Associates 208 Barrington Overlook Drive Durham, North Carolina 27703

Re: K043156

Trade/Device Name: D-Carie Regulation Number: 872.1745 Regulation Name: Laser Fluorescence Caries Detection Device Regulatory Class: II Product Code: NBL Dated: March 29, 2005 Received: April 1, 2005

Dear Mr. Kyper:

We have reviewed your Section 510(k) premarket notification of intent to market the device we flave reviewed your becalling to (1) the device is substantially equivalent (for the relerenced above and nave determined te to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device interstate comments, or to reay 20, 1978, as sectance with the provisions of Amendments, of to devices that nave obsitions that do not require approval of a premarket the Federal Food, Drug, and Cosment . For ( Prove, market the device, subject to the general approval application (1 Mr 2). - The general controls provisions of the Act include controls provisions of the rec. "The gisting of devices, good manufacturing practice, requirements for annual reagainst misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III II your device is classince (500 above) into scontrols. Existing major regulations affecting (PMA), it may be subject to such adala f Federal Regulations, Title 21, Parts 800 to 898. In your device can be found in the Sous of Peachard - Soncerning your device in the Federal Register.

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Page 2 - Mr. Kyper

Please be advised that FDA's issuance of a substantial equivalence determination does not Please be advised that FDA S Issualled of a substantial stacomplies with other requirements mean that FDA has made a decemination administered by other Federal agencies.
of the Act or any Federal statutes and regulations administered by other Federal agencies. of the Act of ally rederal statutes and regulations, but not limited to: registration You must comply with an the Act 5 requirements (21 CFR Part 801); good manufacturing practice and listing (21 CFR Fart 807), laooling (21 CFR Part 877)
requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820), and if requirements as set form in the quality bystems (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) I his letter will anow you to begin mationing your alence of your device to a premarket notification. The 1271 milling of vilance of vour 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), a If you desire specific advice for your deries at [phone]. Also, please note the regulation please confact the Other or Somphanes and (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the may obtain other general miormation of Consumer Assistance at its toll-free Division of Small or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Ayittey-Michienzi, M.D.

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

510(k) Number (if known): K043156

Device Name: D-Carie

Indication for Use: D-Carie is indicated for aiding in the diagnosis of dental carries

Concurrence of CDRH Office of Device Evaluation

Prescription Use (per 21CFR 801.109) OR

Over-the-counter Use _________________________________________________________________________________________________________________________________________________________

Susan Russo

Tivision Sign-Off) ision of Anesthesiology, General Hospital, Intection Control, Dental De

310(k) Number: K043156