K Number
K050274
Device Name
DIODENT II DENTAL LASER SYSTEM
Date Cleared
2005-04-29

(81 days)

Product Code
Regulation Number
878.4810
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended 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 Soft tissue crown lengthening Sucular 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.
Device Description
Not Found
More Information

Not Found

Not Found

No
The 510(k) summary describes a dental laser system for soft tissue procedures and teeth whitening. There is no mention of AI, ML, image processing, or any data-driven decision-making components. The device appears to be a traditional laser system.

Yes
The device is used for therapeutic procedures such as incision, excision, ablation, and hemostasis of oral soft tissue, as well as treatment of aphthous ulcers and reduction of gingival hypertrophy, which are all interventions aimed at treating a condition or disease.

No
The intended uses listed primarily involve surgical procedures (incision, excision, ablation, vaporization) and hemostasis of oral soft tissue, as well as teeth whitening. These are therapeutic or procedural actions, not diagnostic. While some procedures like "Biopsy incision and excision" involve collecting samples, the device itself is performing the excision, not analyzing or interpreting data for diagnosis.

No

The intended use and predicate devices clearly indicate this is a laser system for oral soft tissue procedures and teeth whitening, which is a hardware-based device, not software-only.

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

  • Intended Use: The intended use clearly describes procedures performed directly on the patient's oral soft tissue and teeth. This includes surgical procedures (incision, excision, ablation, vaporization, hemostasis) and light activation for bleaching.
  • Lack of Diagnostic Function: There is no mention of the device being used to analyze samples (like blood, urine, tissue) in vitro (outside the body) to provide diagnostic information about a patient's health.
  • Anatomical Site: The anatomical sites are oral soft tissue and teeth, which are directly treated by the device.
  • Device Description, Image Processing, AI/ML, Input Imaging Modality: The absence of information in these sections further supports that the device is not involved in analyzing biological samples or images for diagnostic purposes.

IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for diagnosis, monitoring, or screening. This device's function is therapeutic and procedural, not diagnostic.

N/A

Intended Use / Indications for Use

The DioDent II 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
Soft tissue crown lengthening
Sucular 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 (comma separated list FDA assigned to the subject device)

79-GEX

Device Description

Not Found

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): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

Not Found

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

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.

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9. 510(k) Summary

K050274

| Company: | HOY A ConBio (formerly Continuum Electro-Optics, Inc.)
47733 Fremont Blvd
Fremont, CA 94538
(800) 532-1064 phone
(510) 445-4550 fax |
|----------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact: | Jim Green
Vice President of Engineering |
| Device Trade Name: | DioDent II Dental Laser System |
| Common Name: | Dental diode laser |
| Classification Name:
Classification Code: | Instrument, surgical, powered, laser
79-GEX |
| Equivalent Device(s): | DioDent Dental Laser System by HOYA ConBio,
LVIlase by HOYA ConBio,
Aurora by Premier Laser System,
Twilite or Dentek LD-15 Diode Laser System by BioLase
Technologies,
DioLase ST by American Medical Technology (formerly ADT) |
| Intended Use: | The DioDent II 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 LVIlase, the DioDent Dental Laser
System, the Aurora Diode Laser System, the
Twilite/Dentek LD-15, the Dental Diode Laser, and the DioLase
ST are equivalent in operating parameters, physical characteristics,
and intended uses. (NOTE: Of the equivalent devices mentioned
here, only the LVIlase, the DioDent, and the Twilite are cleared for
teeth whitening intended uses. The DioDent II is seeking
clearance for this in this submission). |
| Nonclinical Performance
Data: | None |
| Clinical Performance Data: | None |
| Additional Information: | None |

1

10. Design Control Activities Summary

  • a) Identification of Risk Analysis Methods (see the Risk Analysis Report and the Risk Assessment for the DioDent II Dental Laser System in Appendix II)
  • b) Identification of Required Verification and Validation Activities (see the Risk Assessment Summary For Product table in Appendix II)

2

DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle or bird-like figure with outstretched wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the bird. The text is in all capital letters.

Public Health Service

JUL 3 2008

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Hova ConBio, Inc. % Mr. Jim Green Vice President of Engineering 47733 Freemont Boulevard Freemont, California 94538

Re: K050274 Trade/Device Name: DioDent II 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 4, 2005 Received: February 4, 2005

Dear Mr. Green:

This letter corrects our substantially equivalent letter of February 4. 2005.

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 (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 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

3

Page 2 - Mr. Jonathan S. Kahan

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 continue 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/dsma/dsmamain.html

Sincerely yours,

POL

Mark N. Melkerson
Director

Division of General, Restorative

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and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

4

1. Indications for Use Statement

510(k) Number:K050274
Device Name:DioDent II
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
Soft tissue crown lengthening
Sucular 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.

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)

(Division Sign-Off)
-----------------------

Division of General. Restorative,

and Neuros F. ice

| 14.0
The Career of Children | 1
100 10.00 100
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Amount
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