(14 days)
This device may be used for the following indications (previously cleared under submissions K030523, K071363, and K081589):
General Indications *
- r 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
- 이 Tooth preparation to obtain access to root canal
- Root canal preparation including enlargement 트
- l Root canal debridement and cleaning Root Canal Disinfection
- 트 Laser root canal disinfection after endodontic instrumentation Endodontic Surgery (Root Amputation) Indications
- Flap preparation incision of soft tissue to prepare a flap and expose the bone. 트
- Cutting bone to prepare a window access to the apex (apices) of the root(s). l
- Apicoectomy amputation of the root end. 트
- Root end preparation for retrofill amalgam or composite. 트
- Removal of pathological tissues (i.e., cysts, neoplasm or abscess) and hyperplastic 트 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:
- 트 Excisional and incisional biopsies
- I Exposure of unerupted teeth
- I 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)
- I Frenectomy and frenotomy
- Gingival troughing for crown impressions I
- 미 Gingivectomy
- I Gingivoplasty
- I Gingival incision and excision
- 트 Hemostasis
- I Implant recovery
- .. Incision and drainage of abscesses
- Laser soft tissue curettage of the post-extraction tooth sockets and the periapical 프 area during apical surgery
- 트 Leukoplakia
- Operculectomy 바
- 트 Oral papillectomies
- l Operculectomy
- Oral papillectomies 트
- 트 Pulpotomy
- Pulp extirpation ■
- 트 Pulpotomy as an adjunct to root canal therapy
- Root canal debridement and cleaning 트
- 트 Reduction of gingival hypertrophy
- Removal of pathological tissues (i.e., cysts, neoplasm or abscess) and hyperplastic 트 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 B
- 트 Vestibuloplasty
-
- For use on adult and pediatric patient Laser Periodontal Procedures
- s Full thickness flap
- l Partial thickness flap
- 트 Split thickness flap
- 트 Laser soft tissue curettage
- 트 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 I 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 프 grafting, etc.)
- . Osseous crown lengthening
The Waterlase C100 dental laser system is a diverse device utilized to perform a variety of dental applications. For hard tissue procedures the Waterlase® C100 uses the Erbium, Chromium, Yttrium, Scandium, Gallium Gamet (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, Cr.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® C100 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.
I am sorry, but based on the provided text, I cannot extract the information required to describe the acceptance criteria and the study that proves the device meets them.
The document is a 510(k) Special Summary for the Waterlase C100, which focuses on demonstrating substantial equivalence to previously cleared predicate devices. It lists the device description, indications for use, and confirms that these indications are the same as those previously cleared. The FDA's letter also confirms substantial equivalence.
This type of submission typically does not include detailed study data, acceptance criteria, or performance metrics in the same way a de novo or PMA submission would. It relies on the prior clearance of the predicate devices for performance validation.
Therefore, I cannot provide:
- A table of acceptance criteria and reported device performance.
- Sample size, data provenance for a test set.
- Number and qualifications of experts for ground truth.
- Adjudication method.
- MRMC comparative effectiveness study details.
- Standalone algorithm performance.
- Type of ground truth used.
- Sample size for the training set.
- How ground truth for the training set was established.
This document is a regulatory clearance based on equivalence, not a scientific study report demonstrating novel performance against defined 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.