(41 days)
The VersaWave Dental Er:YAG Laser System is intended for
Hard Tissue General Indications*:
- Class I, II, III, IV and V cavity preparation .
- Carries 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 .
Bone Surgical Indications - Cutting, shaving, contouring and resection of oral osseous tissues (bone) .
- . Osteotomy
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 . Removal of pathological nesues (rom around the apex. Note: Any tissue growth (i.e. tissues (1.6. grandiaren besions) must be submitted to a qualified laboratory for histopathological evaluation.
Laser Periodontal Procedures - Full thickness flap .
- Partial thickness flap .
- Split thickness flap .
- Laser soft tissue curettage .
- Laser son ubsed of our and of the . periodontal pocket
- perfouontal pother
Removal of highly inflamed edematous tissue affected by bacteria penetration of the . pocket lining and 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)
- gingi rai otooming masti, master, many of bone to correct osseous defects and . create physiological 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 the unerupted . teeth (hard and soft tissue impactions)
- Frenectomy and frenotomy .
- Gingival troughing for crown impressions .
- Gingivectomy .
- . Gingivoplasty
- Gingival incision and excision .
- Hemostasis and coagulation .
- Implant recovery ●
- Incision and drainage of abscesses .
- Incision and drainage of periapical 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, abscess) and hyperplastic . tissues (i.e. granulation tissue). Note: any tissue growth (i.e., cyst, neoplasm or other tissues (f.c. grandration aboratory for histopathological evaluation.
- Root canal debridement and cleaning .
- Soft tissue crown lengthening .
- Treatment of canker sores, herpetic and aphthous ulcers of the oral mucosa .
- Vestibuloplaty .
*For use on adult and pediatric patients
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The provided document, K041710, is a 510(k) summary for the VersaWave Dental Er:YAG Laser System. It focuses on establishing substantial equivalence to existing predicate devices based on operating parameters, physical characteristics, and intended uses. Crucially, the document explicitly states "Nonclinical Performance Data: None" and "Clinical Performance Data: None." This means there is no study described within this document that proves the device meets any specific acceptance criteria beyond being substantially equivalent to legally marketed devices.
Therefore, I cannot fulfill the request to provide:
- A table of acceptance criteria and reported device performance.
- Sample size used for the test set and data provenance.
- Number of experts used to establish ground truth and their qualifications.
- Adjudication method for the test set.
- Information on a multi-reader multi-case (MRMC) comparative effectiveness study.
- Information on a standalone performance study.
- The type of ground truth used.
- Sample size for the training set.
- How ground truth for the training set was established.
The document indicates that the VersaWave Dental Er:YAG Laser System was cleared based on its substantial equivalence to other dental laser systems already on the market, not on new performance data demonstrating its ability to meet specific acceptance criteria.
The "Comparison" section explicitly states: "The VersaWave Dental Er: YAG Laser System, the DELight Er: YAG Laser System, the WaterLase, Millennium Dental Laser System, and the Premier Centauri Dental Laser System are equivalent in operating parameters, physical characteristics, and intended uses." This comparison is the basis for the 510(k) clearance, not a new study with acceptance criteria.
§ 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.