(128 days)
No
The device description focuses on the laser technology and its delivery system, with no mention of AI or ML capabilities. The "Mentions AI, DNN, or ML" section is explicitly marked as "Not Found".
Yes
The device is used for a variety of treatment procedures related to oral soft tissue, including excision, ablation, hemostasis, and treatment of various oral conditions, which are therapeutic interventions.
No
The "Intended Use / Indications for Use" section lists various surgical and treatment procedures (e.g., incision, excision, ablation), and also cosmetic procedures (teeth whitening), but none of these descriptions indicate that the device is used to diagnose a medical condition.
No
The device description clearly outlines hardware components such as a laser source, delivery system with fiber and handpiece, footswitch, and touch-screen display panel.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are devices intended for use in the collection, preparation, and examination of specimens taken from the human body (such as blood, urine, or tissue) to provide information for the diagnosis, treatment, or prevention of disease.
- Device Function: The description clearly states the device is a laser system used for the direct treatment of oral soft tissue and teeth through incision, excision, ablation, vaporization, hemostasis, and light activation for bleaching. It directly interacts with the patient's body.
- Lack of Specimen Analysis: There is no mention of the device collecting, preparing, or analyzing any specimens from the body. Its function is therapeutic and procedural, not diagnostic based on in vitro analysis.
Therefore, the DioDent Micro 810/980 is a therapeutic medical device, not an IVD.
N/A
Intended Use / 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.
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) 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.
Product codes
GEX
Device Description
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. The laser can operate in continuous wave or pulse mode.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Oral soft tissue
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Nonclinical Performance Data: None
Clinical Performance Data: None
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
SIROLaser by Sirona Dental Systems, K053161, DioDent II Dental Laser System by HOYA ConBio, K050274, Twilight Diode Laser System by BioLase Technologies, K991994
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 878.4810 Laser surgical instrument for use in general and plastic surgery and in dermatology.
(a)
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.
(b)
Classification. (1) Class II.(2) Class I for special laser gas mixtures used as a lasing medium for this class of lasers. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 878.9.
0
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: 510-445-4500 Fax: 510-445-4550
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
1
The laser can operate in continuous wave or pulse mode.
| Intended 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. |
|----------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Comparison: | The DioDent II, the SIROLaser, and the Twilight
are equivalent in operating parameters, physical characteristics,
and intended uses. (NOTE: Of the equivalent devices, only the
DioDent II is cleared for teeth whitening intended uses). |
| Nonclinical Performance
Data: | None |
| Clinical Performance Data: | None |
| Additional Information: | None requested at this time. |
. .
:
:
:
:
2
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.
3
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 (240) 276-0115. 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 (800) 638-2041 or (240) 276-3150 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
4
Attachment 4: Indications for Use Statement
Indications for Use Statement
510(k) Number:
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
5
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)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Posted November 13, 2003)
Page 1 of 1
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(Division Sign-Off) (Division Sign-On)
Division of General, Restorative,
Division of General, Devices Division of Secological Devices 510(k) Number