DIODENT MICRO DENTAL LASER SYSTEM, MODELS 810 AND 980

K063384 · Hoya Conbio, Inc. · GEX · Mar 16, 2007 · General, Plastic Surgery

Device Facts

• Record ID: K063384
• Device Name: DIODENT MICRO DENTAL LASER SYSTEM, MODELS 810 AND 980
• Applicant: Hoya Conbio, Inc.
• Product Code: GEX · General, Plastic Surgery
• Decision Date: Mar 16, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4810
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

The DioDent Micro 810/980 Dental Laser System is intended for incision excision, ablation, vaporization, and/or coagulation of oral soft tissue (including marginal and interdental gingival and epithelial lining of free gingiva). It is also intended for light activation for bleaching materials for teeth whitening, and laser assisted bleaching/whitening for teeth whitening.

Device Story

DioDent Micro 810/980 is a solid-state Gallium Aluminum Arsenide (GaAlAs) semiconductor diode laser. It emits invisible laser energy at 810nm or 980nm wavelengths. The system includes an autoclavable flexible treatment fiber and handpiece. Operated by a clinician in a dental setting, the device is activated via a footswitch. A color touch-screen display allows adjustment of laser output levels. The laser operates in continuous wave or pulse modes to perform soft tissue surgery (incision, excision, ablation, vaporization, coagulation) or to activate bleaching materials for teeth whitening. By providing precise tissue interaction, the device facilitates various oral surgical procedures and cosmetic whitening, potentially reducing patient discomfort and recovery time compared to traditional methods.

Clinical Evidence

No clinical data provided. Bench testing only.

Technological Characteristics

Solid-state Gallium Aluminum Arsenide (GaAlAs) semiconductor diode laser. Wavelengths: 810nm or 980nm. Delivery system: autoclavable flexible treatment fiber and handpiece. Operation: continuous wave or pulse mode. User interface: color touch-screen display. Energy source: electrical, footswitch-controlled.

Indications for Use

Indicated for incision, excision, ablation, vaporization, and hemostasis of oral soft tissue in patients requiring dental procedures such as biopsies, frenectomy, gingivectomy, implant recovery, pulpotomy, and sulcular debridement. Also indicated for light-activated teeth whitening.

Regulatory Classification

Identification

(1) A carbon dioxide laser for use in general surgery and in dermatology is a laser device intended to cut, destroy, or remove tissue by light energy emitted by carbon dioxide.(2) An argon laser for use in dermatology is a laser device intended to destroy or coagulate tissue by light energy emitted by argon.

Predicate Devices

• SIROLaser by Sirona Dental Systems (K053161)
• DioDent II Dental Laser System by HOYA ConBio (K050274)
• Twilight Diode Laser System by BioLase Technologies (K991994)

Submission Summary (Full Text)

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HOYA ConBio, Inc. Traditional 510(k) DioDent Micro 810/980

### MAR 1 6 2007

## 510k Summary

Submitter:

Contact:

Hoya ConBio, Inc. 47733 Fremont Blvd. Fremont, California 94538 Phone: [phone] Fax: [phone]

Liza Burns Regulatory Consultant

November 7, 2006

Dental Diode Laser

79-GEX

Date Summary Prepared:

Device Trade Name:

Common Name:

Classification Name:

Classification Code:

Equivalent Device:

Device Description:

878.4810 Laser surgical instrument for use in general and plastic surgery and in dermatology (1) A carbon dioxide laser for use in general surgery and in dermatology is a laser device intended to

Instrument, surgical, powered, laser

DioDent Micro 810 Dental Laser System DioDent Micro 980 Dental Laser System

dioxide. (2) An argon laser for use in dermatology is a laser device intended to destroy or coagulate tissue by light energy emitted by argon.

cut, destroy, or remove tissue by light energy emitted by carbon

SIROLaser by Sirona Dental Systems, K053161 DioDent II Dental Laser System by HOYA ConBio, K050274 Twilight Diode Laser System by BioLase Technologies, K991994

The laser source of the DioDent Micro 810/980 is a solid-state Gallium Aluminum Arsenide (GaAlAs) semiconductor diode. It produces invisible laser energy at the 810-nanometer or 980nm wavelength. The delivery system consists of an autoclavable flexible treatment fiber threaded through a lightweight, autoclavable hand piece. Activation occurs when the operator enables the laser and presses the footswitch. Releasing the footswitch suspends laser treatment. The footswitch can function as an on/off switch. A color touch-screen display panel allows the operator to adjust or set laser output level with minimal effort.

Proprietary Information

K063384

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The laser can operate in continuous wave or pulse mode.

| Intended Use: | The DioDent Micro 810/980 Dental Laser System is intended for<br>incision excision, ablation, vaporization, and/or coagulation of<br>oral soft tissue (including marginal and interdental gingival and<br>epithelial lining of free gingiva). It is also intended for light<br>activation for bleaching materials for teeth whitening, and laser<br>assisted bleaching/whitening for teeth whitening. |
|----------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Comparison: | The DioDent II, the SIROLaser, and the Twilight<br>are equivalent in operating parameters, physical characteristics,<br>and intended uses. (NOTE: Of the equivalent devices, only the<br>DioDent II is cleared for teeth whitening intended uses). |
| Nonclinical Performance<br>Data: | None |
| Clinical Performance Data: | None |
| Additional Information: | None requested at this time. |

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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 features a stylized eagle with its wings spread, enclosed within a circle. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES . USA" is arranged around the upper portion of the circle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Hoya ConBio, Inc. % Ms. Liza Burns Regulatory Consultant 47733 Fremont Boulevard Fremont, California 94538

MAR 1 6 2007

Re: K063384

Trade/Device Name: DioDent Micro 810 Dental Laser System Regulation Number: 21 CFR 878.4810 Regulation Name: Laser surgical instrument for use in general and plastic surgery and in dermatology Regulatory Class: II Product Code: GEX Dated: February 5, 2007 Received: February 9, 2007

Dear Ms. Burns:

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.

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.

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Page 2 - Ms. Liza Burns

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,

Mark N. Mellor

Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# Attachment 4: Indications for Use Statement

#### Indications for Use Statement

510(k) Number:

K063384

Device Name:

DioDent Micro 810™, DioDent Micro 980™

Indications for Use:

For the incision, excision, ablation, vaporization, and hemostasis of oral soft tissue.

Examples:

Excisional and incisional biopsies Exposure of unerupted teeth Fibroma removal Frenectomy and frenotomy Gingival troughing for crown impressions Gingivectomy Gingivoplasty Gingival incision and excision Hemostasis Implant recovery Incision and drainage of abscess Leukoplakia Operculectomy Oral papillectomies Pulpotomy Pulpotomy as an adjunct to root canal therapy Reduction of gingival hypertrophy Reduction of bacterial level (decontamination) and inflammation Soft tissue crown lengthening Sulcular debridement (removal of diseased or inflamed soft tissue in the periodontal pocket to improve clinical indices including gingival index, gingival bleeding index, probe depth, attachment loss and tooth mobility)

Proprietary Information

Page 95

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HOYA ConBio, Inc.

Traditional 510(k) DioDent Micro 810/980 Treatment of aphthous ulcers Vestibuloplasty Biopsy incision and excision Lesion (tumor) removal

For light activation for bleaching materials for teeth whitening For laser-assisted bleaching/whitening for teeth.

Prescription Use __ X (21 CFR 801 Subpart D)

OR

Over-the-Counter Use (21 CFR 801 Subpart C)

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Concurrence of CDRH, Office of Device Evaluation (ODE)

(Posted November 13, 2003)

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