(61 days)
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
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- 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
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
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
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
- 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
NOTE: Any tissue growth (i.e., cyst, neoplasm or other lesions) must be submitted to a qualified laboratory for histopathological evaluation. - Soft tissue crown lengthening
- Treatment of canker sores, herpetic and aphthous ulcers of the oral mucosa
- Vestibuloplasty
- For use on adult and pediatric patient
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
- Removal of subgingival calculi in periodontal pockets with periodontitis by closed or open curettage
- Waterlase MD Er,Cr:YSGG assisted new attachment procedure (cementum-mediated periodontal ligament new-attachment to the root surface in the absence of long junctional epithelium)
The Waterlase MD Turbo Plus is a dental laser device indicated for incision, excision, removal, and specific dental therapies, such as root canal therapy and periodontal therapy. All indications for use submitted for the Waterlase® MD Turbo Plus have been previously cleared by the FDA and there are no new indications included for this device.
This K101658 510(k) submission for the Waterlase MD Turbo Plus does not contain specific acceptance criteria or a detailed clinical study demonstrating the device's performance against such criteria. Instead, it relies on substantial equivalence to previously cleared predicate devices.
Here's a breakdown based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance:
The document does not specify quantitative acceptance criteria or report device performance in a formal table with metrics like sensitivity, specificity, accuracy, etc. The "performance" described is largely qualitative and comparative to predicate devices.
| Acceptance Criteria (Not explicitly stated as numeric targets) | Reported Device Performance (as described in the "Discussion") |
|---|---|
| Equivalency for higher energy per pulse (600 mJ) | Equivalent to Waterlase® MD Turbo (predicate K090181) at 600 mJ per pulse for preparation of Class II cavities |
| Equivalency for higher energy per pulse (600 mJ) to other predicates | Equivalent to predicate devices cleared under K030146 and K070355 for 600 mJ per pulse |
| Safety and Effectiveness for additional pulse frequencies (75 and 100 Hz) | Determined safe and effective through performance data for gingivoplasty on pig jaw gingiva at 75 and 100 Hz, demonstrating equivalency to cleared indication for predicate devices. |
2. Sample Size Used for the Test Set and Data Provenance:
- Test Set Sample Size: Not explicitly stated. For the higher energy per pulse, it mentions "comparison of class II cavity preparations prepared at 600 mJ per pulse." For the new frequencies, it mentions "Gingivoplasties performed at the two new frequencies on pig jaw gingiva." No specific numbers of preparations or gingivoplasties are provided.
- Data Provenance: The document does not specify the country of origin. The test for gingivoplasty was performed on "pig jaw gingiva," indicating an in vitro or ex vivo animal model rather than human clinical data. The comparison of Class II cavity preparations suggests an in vitro or ex vivo setting as well, given the lack of clinical study details. The data is likely retrospective in the sense that it's a comparison to established performance of predicate devices, or bench/laboratory for the specific tests mentioned.
3. Number of Experts Used to Establish Ground Truth and Qualifications:
- Number of Experts: Not mentioned.
- Qualifications of Experts: Not mentioned.
4. Adjudication Method for the Test Set:
- Adjudication Method: Not mentioned.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
No, an MRMC comparative effectiveness study was not performed. The submission explicitly states: "No clinical performance data is required for this submission." The equivalency is established through comparison to predicate devices and limited performance data (Class II cavity preparations and gingivoplasties on pig jaw gingiva), not through human reader studies.
6. Standalone (i.e., algorithm only without human-in-the-loop performance) Study:
The Waterlase MD Turbo Plus is a physical dental laser device, not an algorithm. Therefore, a "standalone algorithm performance" study is not applicable. The performance data mentioned (cavity preparations, gingivoplasties) represents the device's direct physical interaction with tissue.
7. Type of Ground Truth Used:
- For the Class II cavity preparations, the "ground truth" implicitly refers to the established effectiveness and safety of the predicate device (Waterlase® MD Turbo) for this application. The new device's performance is compared to this established benchmark.
- For the gingivoplasties on pig jaw gingiva, the "ground truth" would be the observed clinical effect (e.g., successful tissue removal, absence of adverse effects) as assessed by technical or dental experts, compared to the expected outcome from predicate devices for a similar indication. This is a technical assessment rather than a diagnostic "ground truth" like pathology or clinical outcomes in a human patient.
8. Sample Size for the Training Set:
This is irrelevant as the Waterlase MD Turbo Plus is a physical device and not an AI/ML algorithm that requires a training set.
9. How the Ground Truth for the Training Set Was Established:
This is irrelevant as the Waterlase MD Turbo Plus is a physical device and not an AI/ML algorithm.
§ 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.