(81 days)
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.
Not Found
The provided text is a 510(k) Summary for the DioDent II Dental Laser System. It explicitly states "Nonclinical Performance Data: None" and "Clinical Performance Data: None."
Therefore, based on the provided input:
1. A table of acceptance criteria and the reported device performance:
There are no acceptance criteria or reported device performance data provided in the document.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
No sample size, test set, or data provenance information is provided as no clinical performance data was submitted.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
Not applicable, as no clinical performance data was submitted, and therefore no ground truth establishment was described.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
Not applicable, as no clinical performance data was submitted.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
Not applicable. This device is a dental laser system, not an AI-assisted diagnostic tool. No comparative effectiveness study of this nature was conducted or reported.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. This device is a dental laser system, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
Not applicable, as no clinical performance data was submitted.
8. The sample size for the training set:
Not applicable, as no clinical performance data was submitted and this device is not an AI/ML algorithm requiring a training set.
9. How the ground truth for the training set was established:
Not applicable, as no clinical performance data was submitted and this device is not an AI/ML algorithm.
{0}------------------------------------------------
9. 510(k) Summary
| Company: | HOY A ConBio (formerly Continuum Electro-Optics, Inc.)47733 Fremont BlvdFremont, CA 94538(800) 532-1064 phone(510) 445-4550 fax |
|---|---|
| Contact: | Jim GreenVice President of Engineering |
| Device Trade Name: | DioDent II Dental Laser System |
| Common Name: | Dental diode laser |
| Classification Name:Classification Code: | Instrument, surgical, powered, laser79-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 BioLaseTechnologies,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 softtissue (including marginal and interdental gingival and epitheliallining of free gingiva). It is also intended for light activation forbleaching materials for teeth whitening, and laser-assistedbleaching/whitening for teeth whitening. |
| Comparison: | The DioDent II, the LVIlase, the DioDent Dental LaserSystem, the Aurora Diode Laser System, theTwilite/Dentek LD-15, the Dental Diode Laser, and the DioLaseST are equivalent in operating parameters, physical characteristics,and intended uses. (NOTE: Of the equivalent devices mentionedhere, only the LVIlase, the DioDent, and the Twilite are cleared forteeth whitening intended uses. The DioDent II is seekingclearance for this in this submission). |
| Nonclinical PerformanceData: | 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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Pre Don
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6
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, andhemostasis of oral soft tissue.Examples:Excisional and incisional biopsiesExposure of unerupted teethFibroma removalFrenectomy and frenotomyGingival troughing for crown impressionsGingivectomyGingivoplastyGingival incision and excisionHemostasisImplant recoveryIncision and drainage of abscessLeukoplakiaOperculectomyOral papillectomiesPulpotomyPulpotomy as an adjunct to root canal therapyReduction of gingival hypertrophySoft tissue crown lengtheningSucular debridement (removal of diseased or inflamed softtissue in the periodontal pocket to improve clinical indicesincluding gingival index, gingival bleeding index, probedepth, attachment loss and tooth mobility)Treatment of aphthous ulcersVestibuloplastyBiopsy incision and excisionLesion (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) | |
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Division of General. Restorative,
and Neuros F. ice
| 14.0The Career of Children | 1100 10.00 100lAmount------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ |
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§ 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.