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General Indications *

• · Class I, II, III, IV and V cavity preparation
• · Caries removal
• · Hard tissue surface roughening or etching
• " Enameloplasty, excavation of pits and fissures for placement of sealants

• For use on adult and pediatric patients

Root Canal Hard Tissue Indications

• Tooth preparation to obtain access to root canal
• · Root canal preparation including enlargement
• · Root canal debridement and cleaning

Endodontic Surgery (Root Amputation) Indications

• · Flap preparation incision of soft tissue to prepare a flap and expose the bone.
• " Cutting bone to prepare a window access to the apex (apices) of the root(s).
• · Apicoectomy amputation of the root end.
• · Root end preparation for retrofill amalgam or composite.
• · Removal of pathological tissues (i.e., cysts, neoplasm or abscess) and hyperplastic tissues (i.e., granulation tissue) from around the apex
• · Incision and drainage of periapical abscesses.
  NOTE: Any tissue growth (i.e., cyst, neoplasm or other lesions) must be submitted to a qualified laboratory for histopathological evaluation.

Bone Surgical Indications

• " Cutting, shaving, contouring and resection of oral osseous tissues (bone)
• · Osteotomy

Laser Periodontal Procedures

• " Full thickness flap
• · Partial thickness flap
• · Split thickness flap
• · Laser soft tissue curettage
• · Laser removal of diseased, infected, inflamed and necrosed soft issue within the periodontal pocket
• Removal of highly inflamed edematous tissue affected by bacteria penetration of the pocket lining junctional epithelium
• · Removal of granulation tissue from bony defects
• · Sulcular debridement (removal of diseased, infected, inflamed or necrosed soft tissue in the periodontal pocket to improve clinical indices including gingival index, gingival bleeding index, probe depth, attachment loss and tooth mobility)
• · Osteoplasty and osseous recontouring (removal of bone to correct osseous defects and create physiologic osseous contours)
• · Ostectomy (resection of bone to restore bony architecture, resection of bone for grafting, etc.)
• · Osseous crown lengthening

Soft Tissue Indications including Pulpal Tissues*
Incision, excision, vaporization, ablation and coagulation of oral soft tissues, including:

• · Excisional and incisional biopsies
• · Exposure of unerupted teeth
• · Fibroma removal
• " Flap preparation incision of soft tissue to prepare a flap and expose the bone.
• " Flap preparation incision of soft tissue to prepare a flap and expose unerupted teeth (hard and soft tissue impactions)
• · Frenectomy and frenotomy
• · Gingival troughing for crown impressions
• · Root canal debridement and cleaning
• · Gingivectomy
• · Gingivoplasty
• · Gingival incision and excision
• · Hemostasis
• " Implant recovery
• · Incision and drainage of abscesses
• " Laser soft tissue curettage of the post-extraction tooth sockets and the periapical area during apical surgery
• Leukoplakia
• · Operculectomy
• · Oral papillectomies
• · Pulpotomy
• · Pulp extirpation
• · Pulpotomy as an adjunct to root canal therapy
• Reduction of gingival hypertrophy
• " Removal of pathological tissues (i.e., cysts, neoplasm or abscess) and hyperplastic tissues (i.e., granulation tissue) from around the apex
  . Soft tissue crown lengthening
• · Treatment of canker sores, herpetic and aphthous ulcers of the oral mucosa
• · Vestibuloplasty

• For use on adult and pediatric patient

The Waterlase® 3.0 hydrokinctic dental laser system is a diverse device utilized to perform a variety of applications. For hard tissue procedures the Waterlase 3.0 uses the Erbium, dental Chromium: Ytrium, Scandium, Gallium Garnet (Er,Cr.YSGG) laser in combination with advanced water atomization spray technology to cut, remove, roughen and etch tissues. Soft tissue procedures are performed using a different mode of operation where direct Er. YSGG laser energy is applied to incise, excise or ablate these tissues. In soft tissue procedures the water spray is applied for hydration, cooling or to keep tissues clean. For hard tissue applications the spray is part of the tissue removing process as well as hydration, cooling and keeping tissues clean.
A flexible fiberoptic handpiece delivers the Waterlase@3.0 laser energy. A visible light emitted from the handpiece distal end pinpoints the area of treatment. In both hard and soft tissue applications the power output, pulse energy, repetition rate (frequency) and air and water flow rates are adjustable to specific user requirements. to specific user requirements.

This document is a 510(k) Special Summary for the Biolase Technology, Inc. Waterlase® 3.0, an Er,Cr:YSGG laser system. It describes the device, its indications for use, and confirms its substantial equivalence to a previously cleared predicate device (Waterlase® K030523).

1. Table of Acceptance Criteria and Reported Device Performance:

The provided document does not contain acceptance criteria or performance data in the traditional sense of a clinical study demonstrating specific efficacy metrics. This is a 510(k) Special Summary, which typically focuses on demonstrating that a modified device is substantially equivalent to a previously cleared predicate device, rather than providing new clinical performance data against specific acceptance criteria. The "performance" described is the device's functional capabilities (e.g., cutting, removing, etching tissues) and its intended applications, which are considered equivalent to the predicate device.

Therefore, a table of acceptance criteria and reported device performance, as would be found in a clinical study report with quantitative outcomes, cannot be extracted from this document. The basis for clearance is substantial equivalence to an existing device, meaning its safety and effectiveness are considered the same as the predicate.

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

No test set or clinical study data (prospective or retrospective) is mentioned in this 510(k) Special Summary. The demonstration of substantial equivalence relies on device design, technological characteristics, and intended uses being similar to the predicate device.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:

Not applicable. No test set or ground truth establishment related to clinical performance is described.

4. Adjudication Method for the Test Set:

Not applicable. No test set or adjudication process is described.

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

No MRMC study is mentioned. The submission is for substantial equivalence to a predicate device, not for a comparative effectiveness study with human readers.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:

Not applicable. This device is a laser system, not an AI algorithm, so the concept of standalone performance for an algorithm is not relevant.

7. Type of Ground Truth Used:

Not applicable. The document does not describe the use of a ground truth in the context of clinical performance evaluation for this submission. The "ground truth" for this 510(k) is the established safety and effectiveness of the predicate device.

8. Sample Size for the Training Set:

Not applicable. The device is a medical instrument (laser system), not an AI algorithm that requires a training set.

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

Not applicable. As above, this is not an AI algorithm.

Summary of Device Acceptance (based on the provided document):

The Waterlase® 3.0 was accepted by the FDA based on a 510(k) Special Summary demonstrating substantial equivalence to a previously cleared predicate device, the Waterlase® (K030523).

• Acceptance Criteria (Implied by 510(k) Special): The Waterlase® 3.0 must have the same intended use, technological characteristics, and fundamental scientific technology as the predicate device, or have different technological characteristics that do not raise new questions of safety or effectiveness and are supported by appropriate data.
• Study Proving Acceptance: The "study" is the comparison analysis performed by Biolase Technology, Inc. presented in the 510(k) submission, asserting that the Waterlase® 3.0's device description, operational modes, and indications for use are "the same as indications that have been previously cleared by the FDA for the predicate device."

Key Takeaway: This document is a regulatory submission focused on proving equivalence for a laser device, not a report on a clinical trial with specific performance metrics and acceptance criteria. Therefore, most of the requested fields are not applicable to the information contained within.

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