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510(k) Data Aggregation
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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. Root Canal Hard Tissue Indications: Tooth preparation to obtain access to root canal; Root canal preparation including enlargement; Root canal debridement and cleaning. Root Canal Disinfection: Laser root canal disinfection after endodontic treatment. 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. Bone Surgical Indications: Cutting, shaving, contouring and resection of oral osseous tissues (bone); Osteotomy. 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; 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; Root canal debridement and cleaning; 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. Laser Periodontal Procedures: Full thickness flap; Partial thickness flap; Split thickness flap; Laser soft tissue curettage; Laser removal of diseased, inflamed and necrosed soft tissue 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, 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.
The Waterlase MD is a dental laser device previously cleared by the FDA for hard and soft tissue dental indications (K031140, K071363). The only changes from the previously cleared device are the addition of the Turbo handpiece, which combines minor software and graphics changes that will be added to the Waterlase MD laser system. This software does not change the operational software, but adds a "Select" icon on the control panel, and unassigned pre-sets fields for use by the dentist to store preferred setting selections. There are no other hardware or software changes to the Waterlase MD device pending herein when compared to the device cleared under K031140 and K071363. Materials used for the Turbo handpiece are the same as those for the MD Gold handpiece. Biocompatibility testing of these materials was conducted in compliance with 21 CFR Part 820, Quality System Regulation, Subpart C, Sec. 820.30 - Design Controls, and ISO 13485-2003, Section 7.3 - Design and Development; documented results (on file) confirmed there is no biocompatibility risk presented by these materials.
This document describes a Special 510(k) submission for the KOGOLFI Waterlase® MD with a new Turbo Handpiece accessory submitted by Biolase Technology, Inc. The core of this submission is to demonstrate substantial equivalence to previously cleared devices (K031140, K071363) by showing that the new accessory does not introduce new questions of safety or effectiveness.
1. Table of Acceptance Criteria and Reported Device Performance:
The provided document does not contain specific acceptance criteria for performance metrics in the traditional sense of a study with quantitative results. Instead, the "acceptance criteria" for this Special 510(k) is the demonstration of substantial equivalence to predicate devices. This means that:
| Acceptance Criteria (Implicit for Special 510(k)) | Reported Device Performance |
|---|---|
| No change in Indications for Use: The new accessory (Turbo Handpiece) should not alter the intended clinical applications as previously cleared for the Waterlase MD. | Met: "The indications included herein are the same as the indications that have been previously cleared by the FDA for the Waterlase®MD (K031140, K071363)." The provided "Indications for Use" section lists the exact same indications as the predicate devices. |
| No change in Contraindications: The new accessory should not introduce any new contraindications. | Met: "All Contraindications remain the same as for the previously cleared device, Waterlase®MD (K031140)." The document explicitly states this. |
| No change in fundamental technology or mode of operation that would raise new questions of safety or effectiveness: The changes should be minor and not impact the core safety and performance characteristics of the laser system. | Met: "The only changes from the previously cleared device are the addition of the Turbo handpiece, which combines minor software and graphics changes that will be added to the Waterlase MD laser system. This software does not change the operational software, but adds a 'Select' icon on the control panel, and unassigned pre-sets fields for use by the dentist to store preferred setting selections. There are no other hardware or software changes to the Waterlase MD device pending herein when compared to the device cleared under K031140 and K071363." This demonstrates the changes are superficial. |
| Biocompatibility of new materials (if any) meets established standards: Any new materials introduced by the accessory must be biocompatible. | Met: "Materials used for the Turbo handpiece are the same as those for the MD Gold handpiece. Biocompatibility testing of these materials was conducted in compliance with 21 CFR Part 820, Quality System Regulation, Subpart C, Sec. 820.30 - Design Controls, and ISO 13485-2003, Section 7.3 - Design and Development; documented results (on file) confirmed there is no biocompatibility risk presented by these materials." This confirms biocompatibility was addressed and meets regulatory requirements. |
| Overall substantial equivalence demonstrated: The new device (Waterlase MD with Turbo Handpiece) is as safe and effective as the predicate devices and does not introduce new questions of safety or effectiveness. This is the overarching "acceptance criterion" of a 510(k) submission, especially a Special 510(k). | Met: "Substantial equivalency for the Waterlase MD with the Turbo Handpiece has been determined through comparison to the previously cleared Waterlase MD." This is the explicit conclusion of the submission, and the FDA's clearance letter affirms this determination. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
No separate "test set" or clinical study data (in terms of patient samples) is referenced for this Special 510(k). This type of submission relies on the existing safety and effectiveness data of the predicate devices. The changes applied (Turbo Handpiece, minor software/graphics) are considered "minor" enough not to necessitate new clinical testing on human subjects for performance.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
Not applicable. As no clinical test set was used for performance evaluation, there were no experts establishing ground truth in this context. The "ground truth" for this submission are the established safety and effectiveness profiles of the predicate devices.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
Not applicable, as no clinical test set was used.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
Not applicable. This device is a dental laser system, not an AI-powered diagnostic tool. Therefore, MRMC studies and AI assistance metrics are not relevant to this submission.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
Not applicable. This device is a physical laser system requiring human operation, not a standalone algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
The "ground truth" in this context is the established safety and effectiveness profile of the predicate devices (Waterlase® MD, K031140, K071363), which were cleared by the FDA based on their own submissions likely involving a combination of performance testing, bench testing, biocompatibility testing, electrical safety testing, and potentially clinical data or reliance on existing scientific literature for similar devices. For this Special 510(k), the "ground truth" is that the modifications do not alter these established profiles.
8. The sample size for the training set:
Not applicable. There is no AI model or "training set" mentioned or implied by the nature of this submission. The "software" changes are described as minor graphical and preset additions, not a learning algorithm.
9. How the ground truth for the training set was established:
Not applicable, as no training set was used.
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