(154 days)
Not Found
Not Found
No
The provided 510(k) summary does not mention AI, ML, or any related technologies in the device description, intended use, or performance studies. The device appears to be a standard dental laser system.
Yes
The device is intended for the incision, excision, ablation, vaporization, and/or coagulation of oral soft tissue, which are therapeutic procedures.
No
The device description focuses on surgical procedures (incision, excision, ablation, vaporization, coagulation) and not on diagnosing conditions.
No
The device is described as a "Dental Laser System" and lists predicate devices that are also laser systems, indicating it is a hardware device.
Based on the provided information, the DioDent Dental Laser System is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use clearly describes procedures performed directly on oral soft tissue within the patient's mouth (incision, excision, ablation, vaporization, coagulation, hemostasis). IVD devices are used to examine specimens (like blood, urine, tissue samples) outside the body to provide information about a person's health.
- Anatomical Site: The anatomical site is "oral soft tissue," which is part of the living patient.
- Lack of IVD Characteristics: There is no mention of analyzing samples, using reagents, or providing diagnostic information based on laboratory tests.
The DioDent Dental Laser System is a surgical device used for treating oral soft tissue.
N/A
Intended Use / Indications for Use
The DioDent Dental Laser System is intended for incision, excision, ablation, vaporization and/or coagulation of oral soft tissue (including marginal and interdental gingiva and epithelial lining of free gingiva).
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 adjunt 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
Product codes
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 (including marginal and interdental gingiva and epithelial lining of free gingiva), periodontal pocket
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)
Aurora by Premier Laser System, TwiLight or Dentek LD-15 Diode Laser System by BioLase Technologies, DioLase ST by American Medical Technology (formerly ADT)
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
013216
510(k) Summary
| Submitter: | Continuum Electro-Optics, Inc.
3150 Central expressway
Santa Clara, CA 95051 | FEB 2 7 2002 |
|-------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------|
| Contact: | Ronald Kohlhardt | |
| Date Summary Prepared: | September 24, 2001 | |
| Device Trade Name: | DioDent Dental Laser System | |
| Common Name: | Medical Laser System | |
| Classification Name: | Instrument, surgical, powered, laser
79-GEX | |
| Equivalent Device(s): | Aurora by Premier Laser System,
TwiLight or Dentek LD-15 Diode Laser System by BioLase
Technologies,
DioLase ST by American Medical Technology (formerly ADT) | |
| Intended Use: | The DioDent Dental Laser System is intended for incision, excision,
ablation, vaporization and/or coagulation of oral soft tissue
(including marginal and interdental gingiva and epithelial lining of
free gingiva). | |
| Comparison: | The DioDent Dental Laser System, Aurora Diode Laser System,
TwiLight/Dentek LD-15 Dental Diode Laser, and DioLase ST are
equivalent in operating parameters, physical characteristics and
intended uses. | |
| Nonclinical Performance Data: | None | |
| Clinical Performance Data: | None | |
| Additional Information: | None | |
000054
1
Image /page/1/Picture/1 description: The image is a black and white seal for the Department of Health & Human Services - USA. The seal is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. In the center of the seal is an abstract image of an eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB 2 7 2002
Mr. Ronald Kohlhardt Director, Regulatory Compliance and Quality Assurance Continuum Electro-Optics, Inc. 3150 Central Expressway Santa Clara, California 95051
Re: K013216
R015216
Trade/Device Name: DioDent Dental Laser System Regulation Number: 878.4810 Regulation Name: Laser surgical instrument for use in general and plastic surgery and in dermatology Regulatory Class: II Product Code: GEX Dated: January 22, 2002 Received: January 23, 2002
Dear Mr. Kohlhardt:
We have reviewed your Section 510(k) premarket notification of intent to market the device We have reviewed your Section > IQ(x) premaited is substantially equivalent (for the indications
referenced above and have determined the device is substantially interstate referenced above and nave detenmined the devices marketed in interstate
for use stated in the enclosure) to legally marketed president Device Amendments. for use stated in the enclosure) to regarly manced to of the Medical Device Amendments, or to
commerce prior to May 28, 1976, the enactment of the Rederal Food. Drue, commerce prior to May 28, 1976, the elaculting of the Frovisions of the Federal Food, Drug, devices that have been recults in accordance who results approval application (PMA).
and Cosmetic Act (Act) that do not require approval assesses provisions of the Act . The and Cosmetic Act (Act) that do not require approvate of the general controls provisions of the Act. The Act. The You may, therefore, market the device, subject to tire gents for annual registration, listing of
general controls provisions of the Act include required misbranding and general controls provisions of the Fect merade roquilibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it If your device is classified (SCC above) mis existing major regulations affecting your device can
may be subject to such additional controls. Existing major regulation EDA may be subject to such additional controlis. Existing major 1998. In addition, FDA may
be found in the Code of Federal Regulations, Title 21, Parts 800 to Register be found in the Code of Federal Regarations, in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised that FDA s issualice of a subscription with other requirements of the Act
that FDA has made a determination that your device complies . You must that FDA has made a decemmanon that your as rees of ther Federal agencies. You must or any Federal statutes and regulations daminders on registration and listing (21 l
comply with all the Act's requirements, including, but not limited to: requirements as set comply with all the Act 3 requirements, mercessed in and in end ice requirements as set
CFR Part 807); labeling (21 CFR Part 801); good manufacturing diff seplicable, the ele CFR Part 807), labeling (21 CFR Part 800); good manat 820); and if applicable, the electronic
forth in the quality systems (QS) regulation (21 CFR 1000 (21 CFR 1000 (1050 forth in the quality systems (Sections 531-542 of the Act); 21 CFR 1000-1050.
product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
2
Page 2 - Mr. Ronald Kohlhardt
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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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 vours.
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
3
Indications for Use Statement
510(k) Number (if known): pending KO | 3 216
Device Name: DioDent Dental Laser System 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 adjunt 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
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| Prescription Use
| (Per 21 CFR 801.109) | |
|---|---|
| ------------------------------------------ | -- |
OR
| Over-the-Counter Use | |
|---|---|
| ---------------------- | -- |
Optional Format 1-2-96)
Mark N Melkinn
(Division Sign-Off)
Division of General, Restorative
and Neurological Devices
| 510(k) Number | K013216 |
|---|---|
| --------------- | --------- |