(140 days)
Not Found
No
The summary describes a laser system with adjustable power and pulse, but there is no mention of AI or ML in the device description, intended use, or performance studies.
Yes
The device is intended for various medical procedures in oral soft tissue, including incision, excision, ablation, and coagulation, as well as teeth whitening, which are therapeutic applications.
No
The device is intended for surgical procedures and teeth whitening, not for diagnosing medical conditions.
No
The device description explicitly states it is a "Dental Diode Laser" and describes hardware components like a "Gallium Aluminum Arsenide (GaAlAs) solid state laser diode" and a "fiber optic held by a handpiece". This indicates it is a hardware device, not software-only.
Based on the provided information, the Dio-Dent 10 Dental Diode Laser System is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices intended to be used in vitro for the examination of specimens, including blood, tissue, and urine, derived from the human body, solely or principally for the purpose of providing information concerning a physiological or pathological state, or concerning a congenital abnormality, or to monitor therapeutic measures.
- Dio-Dent 10 Function: The Dio-Dent 10 Dental Diode Laser System is used for direct treatment of oral soft tissue and teeth within the patient's body (in vivo). It performs procedures like incision, excision, ablation, and teeth whitening.
- No Specimen Analysis: The device does not analyze specimens taken from the body. It directly interacts with the patient's tissues.
Therefore, the intended use and function of the Dio-Dent 10 clearly place it outside the definition of an In Vitro Diagnostic device.
N/A
Intended Use / 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 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
- · 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
Product codes
GEX
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 10 Watts 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.
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)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K983058, K991891, K993002, K993911, K022351, K000990, K011769
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.
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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.
1
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
2
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.
3
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.
4
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
5
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, Restorative | |
| and Neurological Devices | |
| 510(k) Number K031819 |