DETECTAR, MODEL N123-MI

K023367 · Neks Technologies · EJB · Jun 25, 2003 · Dental

Device Facts

• Record ID: K023367
• Device Name: DETECTAR, MODEL N123-MI
• Applicant: Neks Technologies
• Product Code: EJB · Dental
• Decision Date: Jun 25, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.4565
• Device Class: Class 1

Intended Use

DETECTAR is indicated for the detection of subgingival dental calculus.

Device Story

DETECTAR is a dental diagnostic device used by clinicians to detect subgingival dental calculus. The device consists of a probe similar in size and shape to a manual periodontal probe, containing an integrated optical fiber. The probe reads the optical signature of dental calculus and converts it into an electrical signal. A computer analysis processes this signal to identify the presence of calculus. The system provides feedback to the clinician, who uses this information to guide clinical decision-making regarding the removal of calculus. The device is intended to assist in periodontal procedures by identifying calculus particles as small as 0.1 mm2, though the clinical significance of removing particles of this size is unknown.

Clinical Evidence

Bench testing only. An in vitro evaluation compared the DETECTAR to a manual periodontal probe using a simulated periodontium model (pig gingiva on tooth root surfaces with blood). Three experienced clinicians evaluated seven variables. Results indicated the DETECTAR significantly outperformed the manual periodontal probe in detecting subgingival calculus.

Technological Characteristics

The device features a probe with an integrated optical fiber for sensing. It operates by reading optical signatures of dental calculus and converting them into electrical signals for computer-based analysis. The form factor is similar to a manual periodontal probe. It is a Class II device.

Indications for Use

Indicated for detection of subgingival dental calculus in patients requiring periodontal assessment. Clinicians must exercise professional judgment regarding removal of detected calculus particles as small as 0.1 mm2.

Regulatory Classification

Identification

A dental hand instrument is a hand-held device intended to perform various tasks in general dentistry and oral surgery procedures. The device includes the operative burnisher, operative amalgam carrier, operative dental amalgam carver, surgical bone chisel, operative amalgam and foil condenser, endodontic curette, operative curette, periodontic curette, surgical curette, dental surgical elevator, operative dental excavator, operative explorer surgical bone file, operative margin finishing file, periodontic file, periodontic probe, surgical rongeur forceps, surgical tooth extractor forceps, surgical hemostat, periodontic hoe, operative matrix contouring instrument, operative cutting instrument, operative margin finishing periodontic knife, periodontic marker, operative pliers, endodontic root canal plugger, endodontic root canal preparer, surgical biopsy punch, endodontic pulp canal reamer, crown remover, periodontic scaler, collar and crown scissors, endodontic pulp canal filling material spreader, surgical osteotome chisel, endodontic broach, dental wax carver, endodontic pulp canal file, hand instrument for calculus removal, dental depth gauge instrument, plastic dental filling instrument, dental instrument handle, surgical tissue scissors, mouth mirror, orthodontic band driver, orthodontic band pusher, orthodontic band setter, orthodontic bracket aligner, orthodontic pliers, orthodontic ligature tucking instrument, forceps, for articulation paper, forceps for dental dressing, dental matrix band, matrix retainer, dental retractor, dental retractor accessories, periodontic or endodontic irrigating syringe, and restorative or impression material syringe.

Predicate Devices

• Probe®Perio 2000 System (K980749)
• DentalView®PerioView® System (K973492/K982480)
• DIAGNOdent Laser Fluorescence Caries Detection Device (K983658)
• Alpha 4 LS Automated Microtiterplate Processor (K973638)
• Manual periodontal probes [510(k) exempt]

Submission Summary (Full Text)

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JUN 2 5 2003

K023367

## 510(k) Summary

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

2. Contact Person: Daniel Fortin, DMD, MS Vice President for R & D Phone: [phone] Fax: [phone]

3. Date Summary Prepared: June 16, 2003

4. Device Name: DETECTAR

5. Predicate Devices: Probe®Perio 2000 System (K980749) DentalView®PerioView® System (K973492/K982480) DIAGNOdent Laser Fluorescence Caries Detection Device (K983658) Alpha 4 LS Automated Microtiterplate Processor (K973638) Manual periodontal probes [510(k) exempt]

- 6. Device Description and Intended Use:
DETECTAR is indicated for use in the detection of subgingival dental calculus. The DETECTAR probe is similar in intended use, size, and shape to a manual periodontal probe. The DETECTAR probe contains an optical fiber that reads the optical signature of dental calculus and converts it into an electrical signal. From that electrical signal a computer analysis identifies the dental calculus. The labeling includes the following statement:

"CAUTION: The DetecTar™ unit is capable of detecting calculus particles as small as 0.1 mm2. CAUTION SHALL BE EXERCIZED TO AVOID OVERINSTRUMENTATION IN THE REMOVAL OF VERY SMALL PARTICLES OF CALCULUS. The significance of removal of calculus of 0.1mm is presently unknown. Clinically considered professional judgment shall be applied to the determination of whether detected calculus shall be removed."

- 7. Brief Description of Non-clinical Testing:
An in vitro evaluation comparing the DETECTAR with a periodontal probe was conducted by three experienced clinicians. A piece of pig gingiva was set on

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the root surface of the teeth to simulate the periodontium and conceal the root surface. To complete the model, drops of blood were introduced between the gingiva and the tooth before the clinician performed an evaluation. Seven variables were studied. The DETECTAR significantly outperformed the manual periodontal probe.

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

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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 circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized symbol that resembles an abstract human figure or a bird in flight, composed of three curved lines.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN 2 5 2003

NEKS Technologies C/O Mr. Charles H. Kyper Kyper & Associates, LLC 103 Nolen Lane Chapel Hills, North California 27516

Re: K023367 Trade/Device Name: DETECTAR Regulation Number: 872.4565, 872.1745 Regulation Name: Dental Hand Instrument, Laser Fluorescence Caries Detection Device Regulatory Class: II Product Code: EJB, NBL Dated: June 16, 2003 Received: June 17, 2003

Dear Mr. Kyper:

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 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. Kyper

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 (QS) 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/dsma/dsmamain.html

Sincerely vours.

Susa Puma

Susan Runner, DDS, MA Interim 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

K0233667

510(k) Number ( if known):

Device Name: DETECTAR

Indication for Use: DETECTAR is indicated for the detection of subgingival dental calculus

Concurrence of CDRH Office of Device Evaluation

Prescription Use (per 21 CFR 801.109) OR

Over-the-counter Use _________________________________________________________________________________________________________________________________________________________

Kein Muly for MSD
(Division Sign Off)

nesthesiology, General Hospital, ontrol, Dental I

510(k) Number]