(342 days)
Not Found
Not Found
No
The summary explicitly states "Mentions AI, DNN, or ML: Not Found" and the device description and performance studies do not suggest the use of AI/ML.
Yes
The device is described as a "Dental Laser System" used for "Sulcular Debridement," which is a treatment for periodontitis. The performance study compares it to a standard treatment and evaluates patient outcomes, indicating it is used for therapy.
No
The device is described as a "Dental Laser System" used for "Sulcular Debridement," which is a treatment procedure, not a diagnostic one. The performance studies compare treatments and their efficacy, not the device's ability to diagnose a condition.
No
The device is described as a "Dental Laser System," which inherently involves hardware components (the laser itself) and is not solely software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "Sulcular Debridement," which is a procedure performed directly on the patient's intraoral soft tissue.
- Device Description: It's described as a "Dental Laser System," which is a therapeutic device used for treatment.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (like blood, urine, or tissue samples) outside of the body to provide information for diagnosis, monitoring, or screening. The description focuses on a clinical procedure performed on the patient.
IVD devices are specifically designed to be used in vitro (outside the living organism) to analyze biological samples. This device is used in vivo (within the living organism) for treatment.
N/A
Intended Use / Indications for Use
Sulcular Debridement
Product codes
Not Found
Device Description
Not Found
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
intraoral
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
A clinical study has been carried out which compared the laser treatment to a standard treatment for patients with periodontitis. The standard treatment used mechanical scaling and root planing for the root surface as well as soft-tissue curettage. The laser treatment used mechanical scaling and root planing for the root surface, followed by laser debridement of the diseased epithelial layers as well as for any chronically inflamed connective tissue.
The patients were treated with standard treatment, laser treatment, or no-treatment on different quadrants of the mouth which were randomly assigned.
For safety, pulp evaluations and tooth surface conditions were performed by blinded evaluators. There were no changes observed in the surface condition of any teeth from pretreatment to post-treatment. There were no differences in pulp condition between the laser treatment and the standard treatment.
For efficacy, clinical indices and microbiological measurements were made. There were significant differences between the treated teeth and the no treatment teeth in several of the indices at one month and three months. The laser treatment and standard treatment showed equivalent results. By six months all treatment differences had disappeared.
Summary of Performance Studies
The results of the study allow the following conclusions:
There are no new safety risks for this laser procedure. All teeth in the study were healthy out to six months.
The laser treatment is equivalent to other laser soft-tissue removal procedures in the oral cavity.
The laser treatment for the sulcular debridement and bacterial reduction is equivalent to the standard treatment in terms of effectiveness based on both the improvement in clinical indices
Key Metrics
Not Found
Predicate Device(s)
Not Found
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
Image /page/0/Picture/0 description: The image shows the logo for American Dental Technologies. The logo is in black and features the company name in a bold, sans-serif font. There is a horizontal line below the company name. To the right of the line is a small starburst symbol.
510(k) Summary
K 96 126 9
MAR 1 0 1997
Device Name:
Trade Name:
Common Name:
Dental Laser System
PuiseMaster
Classification Name:
Indication for Use
Surgical Laser System
Sulcular Debridement
Submitter:
American Dental Technologies, Inc. 125 Shoreway Road Suite 3000 San Carlos, CA 94070
Contact Person:
Michael Yessik Tel.: 415-595-7723 Fax: 415-595-3982
Date Prepared:
March 28, 1996
nk
125 Shoreway Road ▪ Suite 3000 ▪ San Carlos, CA 94070 ▪ (415) 595 7723 Fax (415) 595 3982
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1
This 510(k) Premarket Notification is for a new indication for use for the legally marketed PulseMaster laser family. The use of the PulseMaster laser for sulcular debridement and bacterial reduction is substantially equivalent to the PulseMaster laser for ablation, incision, and excision of other intraoral soft tissue.
A clinical study has been carried out which compared the laser treatment to a standard treatment for patients with periodontitis. The standard treatment used mechanical scaling and root planing for the root surface as well as soft-tissue curettage. The laser treatment used mechanical scaling and root planing for the root surface, followed by laser debridement of the diseased epithelial layers as well as for any chronically inflamed connective tissue.
The patients were treated with standard treatment, laser treatment, or no-treatment on different quadrants of the mouth which were randomly assigned.
For safety, pulp evaluations and tooth surface conditions were performed by blinded evaluators. There were no changes observed in the surface condition of any teeth from pretreatment to post-treatment. There were no differences in pulp condition between the laser treatment and the standard treatment.
For efficacy, clinical indices and microbiological measurements were made. There were significant differences between the treated teeth and the no treatment teeth in several of the indices at one month and three months. The laser treatment and standard treatment showed equivalent results. By six months all treatment differences had disappeared.
The results of the study allow the following conclusions:
There are no new safety risks for this laser procedure. All teeth in the study were healthy out to six months.
The laser treatment is equivalent to other laser soft-tissue removal procedures in the oral cavity.
The laser treatment for the sulcular debridement and bacterial reduction is equivalent to the standard treatment in terms of effectiveness based on both the improvement in clinical indices