PULSEMASTER

K961269 · American Dental Technologies, Inc. · GEX · Mar 10, 1997 · General, Plastic Surgery

Device Facts

• Record ID: K961269
• Device Name: PULSEMASTER
• Applicant: American Dental Technologies, Inc.
• Product Code: GEX · General, Plastic Surgery
• Decision Date: Mar 10, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4810
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Sulcular Debridement

Device Story

PulseMaster dental laser system; used for sulcular debridement and bacterial reduction. Operates via laser energy for debridement of diseased epithelial layers and chronically inflamed connective tissue. Used in clinical dental settings by practitioners. Complements mechanical scaling and root planing. Output is laser energy application to intraoral soft tissue. Benefits include effective treatment of periodontitis equivalent to standard mechanical scaling/root planing/curettage, with no adverse impact on pulp condition or tooth surface.

Clinical Evidence

Clinical study compared laser treatment (scaling/root planing + laser debridement) vs. standard treatment (scaling/root planing + curettage) vs. no-treatment in periodontitis patients. Evaluated safety (pulp condition, tooth surface) and efficacy (clinical indices, microbiological measurements). Results: No safety risks identified; no changes in tooth surface or pulp condition. Efficacy equivalent to standard treatment at 1 and 3 months; differences disappeared by 6 months.

Technological Characteristics

Dental laser system. Energy source: laser. Form factor: intraoral handpiece system. No specific materials or software algorithms described.

Indications for Use

Indicated for sulcular debridement and bacterial reduction in patients with periodontitis.

Regulatory Classification

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.

Predicate Devices

• PulseMaster laser family (K961269)

Submission Summary (Full Text)

{0}

American Dental Technologies

# 510(k) Summary

K961269

## Device Name:

MAR 10 1997

- Trade Name: PulseMaster
- Common Name: Dental Laser System
- Classification Name: Surgical Laser System
- Indication for Use: **Sulcular Debridement**
~~Sustained Reduction~~

## Submitter:

American Dental Technologies, Inc.
125 Shoreway Road
Suite 3000
San Carlos, CA 94070

## Contact Person:

Michael Yessik
Tel.: [phone]
Fax: [phone]

## Date Prepared:

March 28, 1996

125 Shoreway Road • Suite 3000 • San Carlos, CA 94070 • [phone] Fax [phone]

{1}

Page 2
510(k) Summary

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 use of 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 pre-treatment 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.