The Dio-Dent 10 Dental Diode Laser System is intended for incision, excision, ablation, vaporization and/or coagulation (hemostasis) of oral soft tissue (including marginal and interdental gingiva and epithelial lining of free gingiva). In addition, the system is intended for teeth whitening. The Indications for Use of the Dio-Dent 10 Dental Diode Laser System include: Cosmetic Dentistry - Light activation for bleaching materials for teeth whitening, Laser-assisted bleaching/whitening of the teeth; Endodontology - Pulpotomy, Pulpotomy as an adjunct to root canal therapv; Periodontology - Sulcular debridement (removal of diseased or inflamed soft tissue in the periodental pocket); Oral Soft Tissue Surgery - Biopsy, Operculectomy, Gingivectomy, Gingivoplasty, Oral papillectomy, Leukoplakia, Treatment of aphthous ulcers, Fibroma removal, Frenectomy, Frenotomy, Tissue retraction for impressions. Incising and draining of abscesses, Draining fistulas, Exposure of unerupted partially erupted teeth, Lesion (tumor) removal, Implant recovery, Implant uncovering, Gingival troughing, Crown lengthening, Hemostasis of donor site, Coagulation and decontamination of extraction sites, Removal of granulation tissue, Degranulation of infrabony defects, Laser assisted flap surgery, Vestibuloplasty, Removal of hyperplastic tissues, Debridement of diseased epithelial lining

Device Description

The Dio-Dent 10 Dental Diode Laser is designed to perform several medical procedures in the oral soft tissue and to perform laser assisted aesthetic tooth whitening procedures. A Gallium Aluminum Arsenide (GaAlAs) solid state laser diode provides optical energy to oral soft tissues. A fiber optic held by a handpiece delivers up to 10Watts laser energy. A visible light emitted from the handpiece's distal end targets the area of treatment. The optical power output and pulse may be adjusted to specific use requirements.

AI/ML Overview

The provided text describes a 510(k) premarket notification for the Dio-Dent 10 Dental Diode Laser System. This document focuses on demonstrating substantial equivalence to predicate devices rather than providing detailed acceptance criteria and a study report as typically found for novel devices or software.

Therefore, many of the requested categories for a rigorous study proving device performance against acceptance criteria cannot be answered directly from this type of regulatory submission. The information provided primarily pertains to compliance with safety standards and equivalence to existing devices.

Here's an analysis based on the provided text, highlighting what is (and isn't) present:

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not provide a specific table of acceptance criteria with numerical targets for performance and corresponding results from a dedicated study. Instead, it asserts compliance with general safety and performance standards, and substantial equivalence to predicate devices.

Acceptance Criterion	Reported Device Performance
Safety Standards	Complies with:
U.S. Federal Performance Standards 21 CFR 1040.10 and 21 CFR 1040.11 for class IV Laser Products.	Complies
European Medical Directive 93/42/EEC (Annex II)	Complies
IEC 60601-1	Complies
IEC 60601-1-2	Complies
IEC-60825-1	Complies
IEC 601-2-22	Complies
Technical Characteristics	Similar to cleared Ceralas™ and Opus 10™ predicate devices.
Laser Output Values	Well within previously cleared values of predicate dental diode laser systems.
Intended Use/Indications for Use	Previously cleared by FDA for predicate devices.
Safety and Effectiveness	Predicate devices and other previously cleared lasers with similar energy output have proven safety and effectiveness in the claimed indications.

2. Sample Size Used for the Test Set and Data Provenance:

The document does not describe a clinical test set with a specific sample size. The "study" here is a demonstration of equivalence, relying on the established safety and effectiveness of predicate devices and compliance with recognized standards. There is no mention of a particular cohort of patients or data collected for this specific device's performance validation in a clinical setting.

3. Number of Experts Used to Establish Ground Truth and Qualifications:

Not applicable. The submission is not based on a study with a ground truth established by experts for performance evaluation. It relies on regulatory compliance and equivalence to predicate devices which have already undergone such assessments.

4. Adjudication Method for the Test Set:

Not applicable, as no specific test set requiring adjudication is described.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

No MRMC study is mentioned. The device is a laser system, not an AI or imaging diagnostic tool that would typically undergo such a study.

6. Standalone (Algorithm Only) Performance:

Not applicable. The device is a physical laser system, not an algorithm.

7. Type of Ground Truth Used:

The "ground truth" for this submission is primarily:

Compliance with international and national performance standards (e.g., 21 CFR 1040.10, 21 CFR 1040.11, IEC standards).
Established safety and effectiveness of the predicate devices.
Technical characteristics and output values that fall within the range of already cleared devices.

8. Sample Size for the Training Set:

Not applicable. This is not an AI/machine learning device that involves a "training set."

9. How the Ground Truth for the Training Set Was Established:

Not applicable, as there is no training set for this device.

Summary

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OCT 3 0 2003

Page 1 of 3

510(K) SUMMARY

DIO-DENT 10 DENTAL DIODE LASER SYSTEM

510(k) Number K 031819

Applicant's Name: MSq(M2) Ltd. 7 Haeshel St. P.O.B 3021 Caesarea Industrial Park 38900 Israel Tel: 04-6275357 Fax: 04-6275368 e-mail: zivk@MSg.co.il

Arava Hacohen Contact Person: Push-med Ltd. 117 Ahuzah St. Ra'anana 43373, Israel Tel: 972-9-7718130 Fax: 972-9-7718131 e-mail: arava(@push-med.com

Date Prepared: May 2003

Dio-Dent 10 Dental Diode Laser System Trade Name:

Classification Name: Laser Instrument. Surgical, Powered

FDA has classified laser device as a class II device (product code Classification: GEX) and it is reviewed by the General & Plastic Surgery Panel.

Predicate Devices: The Dio-Dent 10 Dental Diode Laser System substantially equivalent to the Ceralase D 980nm Diode Laser System, Model D15 (Ceramoptec, Inc.) cleared under K983058, K991891, K993002, K993911 and K022351 in terms of technological characteristics, performance, intended use, indications for use and user interface.

In addition, the Dio-Dent 10 is substantially equivalent to the Opus 10 Dental Diode Laser System (OpusDent Ltd.) cleared under K000990 and K011769 in terms of intended use. indication for use. technological characteristics. performance and user interface.

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Performance Standards: The Dio-Dent 10 Diode Laser complies with:

U.S. Federal Performance Standards 21 CFR 1040.10 and 21 CFR 1040.11 for class IV Laser Products.

In addition, the device complies with the European Medical Directive 93/42/EEC concerning medical devices (Annex II) and with the voluntary standards IEC 60601-1, IEC 60601-1-2, IEC-60825-1 and IEC 601-2-22.

Intended Use / Indication for Use: The Dio-Dent 10 Dental Diode Laser System is intended for incision, excision, ablation, vaporization and/or coagulation (hemostasis) of oral soft tissue (including marginal and interdental gingiva and epithelial lining of free gingiva). In addition, the system is intended for teeth whitening.
The Indications for Use of the Dio-Dent 10 Dental Diode Laser System include:

Cosmetic Dentistry

· Light activation for bleaching materials for teeth whitening
· Laser-assisted bleaching/whitening of the teeth

Endodontology

· Pulpotomy
· Pulpotomy as an adjunct to root canal therapy

Periodontology

· Sulcular debridement (removal of diseased or inflamed soft tissue in the periodental pocket)

Oral Soft Tissue Surgery

· Biopsy
· Operculectomy
· Gingivectomy
· Gingivoplasty
· Oral papillectomy
Leukoplakia
Treatment of aphthous ulcers
· Fibroma removal
· Frenectomy
· Frenotomy
· Tissue retraction for impressions
· Incising and draining of abscesses
· Draining fistulas
· Exposure of unerupted partially erupted teeth
· Lesion (tumor) removal
· Implant recovery

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Page 3 of 3

· Implant uncovering
Gingival troughing
· Crown lengthening
· Hemostasis of donor site
· Coagulation and decontamination of extraction sites
· Removal of granulation tissue
· Degranulation of infrabony defects
· Laser assisted flap surgery
· Vestibuloplasty
· Removal of hyperplastic tissues
· Debridement of diseased epithelial lining

The Dio-Dent 10 Dental Diode Laser is designed to perform several Device Description: medical procedures in the oral soft tissue and to perform laser assisted aesthetic tooth whitening procedures.

A Gallium Aluminum Arsenide (GaAlAs) solid state laser diode provides optical energy to oral soft tissues.

A fiber optic held by a handpiece delivers up to 10Watts laser energy. A visible light emitted from the handpiece's distal end targets the area of treatment. The optical power output and pulse may be adjusted to specific use requirements.

Substantial Equivalence: There are no unique applications, material or specifications presented below. Evidence of equivalence has been demonstrated through:

· The Dio-Dent 10 intended use and indications for use were previously cleared by FDA for the predicate devices.
· The technical characteristics of the Dio-Dent 10 are similar to those of the cleared Ceralas™ and Opus 10TM.
· Laser output values of the Dio-Dent 10 are well within previous cleared values of the predicate dental diode laser systems as described.
· The predicate devices and other previous cleared lasers with similar energy output have a proven safety and effectiveness in the treatment of the claimed indications.
· Safety and performance testing.

Therefore. the Dio-Dent 10 Dental Diode Laser System is substantially equivalent to its predicate devices cited above and raises no new safetv and/or effectiveness issues.

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus, which is a symbol often associated with medicine and healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus. The logo is simple and monochromatic.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT 3 0 2003

MSq(M2) Ltd. c/o Mr. Arava Hacohen Push-med Ltd. 117 Ahuzah Street Ra'anana 43373. Israel

Re: K031819 Trade/Device Name: Dio-Dent 10 Dental Diode 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: June 1, 2003 Received: July 30, 2003

Dear Mr. Hacohen:

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 vour 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 - Mr. Arava Hacohen

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 (301) 594-4659. 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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Miriam C. Provost

Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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INDICATIONS FOR USE

510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

Device Name: Dio-Dent 10 Dental Diode Laser System

Indications for Use: The Dio-Dent 10 Dental Diode Laser System is intended for incision, excision, ablation, vaporization and/or coagulation (hemostasis) of oral soft tissue (including marginal and interdental gingiva and epithelial lining of free gingiva). In addition, the system is intended for teeth whitening.

The Indications for Use of the Dio-Dent 10 Dental Diode Laser System include:

Cosmetic Dentistry

Light activation for bleaching materials for teeth whitening, Laser-assisted bleaching/whitening of the teeth

Endodontology

Pulpotomy, Pulpotomy as an adjunct to root canal therapv

Periodontology

Sulcular debridement (removal of diseased or inflamed soft tissue in the periodental pocket)

Oral Soft Tissue Surgery

Biopsy, Operculectomy, Gingivectomy, Gingivoplasty, Oral papillectomy, Leukoplakia, Treatment of aphthous ulcers, Fibroma removal, Frenectomy, Frenotomy, Tissue retraction for impressions. Incising and draining of abscesses, Draining fistulas, Exposure of unerupted partially erupted teeth, Lesion (tumor) removal, Implant recovery, Implant uncovering, Gingival troughing, Crown lengthening, Hemostasis of donor site, Coagulation and decontamination of extraction sites, Removal of granulation tissue, Degranulation of infrabony defects, Laser assisted flap surgery, Vestibuloplasty, Removal of hyperplastic tissues, Debridement of diseased epithelial lining

(PLEASE DO NOT WRITE BELOW THIS LINE -CONTINUE ON ANOTHER PAGE IF NEEDED)

510(k) Number	K031819
Prescription Use(Per 21 CFR 801.109)	OR Over the Counter Use
	Miriam C. Provost(Division Sign-Off)Division of General, Restorativeand Neurological Devices
	510(k) Number K031819

Regulation Number and Section

§ 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.