(315 days)
The OpusDent Family of Er:YAG and CO2/Er:YAG Combination Laser Products (and the delivery accessories that are used with them to deliver laser energy) are intended for use in dental procedures performed in oral and maxillofacial surgery and dentistry.
The OpusDent Dental Laser System is intended to aid during dental procedures performed in oral and maxillofacial surgery and dentistry.
The Er: YAG laser component is indicated for a variety of hard tissue (tooth and bone) applications, and for the incision, excision, cutting, ablation, vaporization, and coagulation of soft tissue in oral and maxillofacial surgery and dentisty.
This includes the following:
Hard Tissue Indications of Er:YAG Laser Energy
- Caries removal
- Cavity preparation
- Enamel etching
- Enameloplasty, excavation of pits and fissures for placement of sealant
Bone Indications of Er:YAG Laser Energy
- Contact and non-contact cutting, shaving, contouring, and resection of oral osseous tissue (bone)
- Apicoectomy - amputation of the root end
- Osseous crown lengthening
- Cutting bone to prepare a window access to the apex (apices) of the root(s)
- Osseoplasty
- Osteotomy
Soft Tissue and Periodontal Indications of Er: YAG Laser Energy
- Excisional and incisional biopsies
- Exposure of unerrupted teeth
- Incision and drainage of abscesses
- Gingival incision and excision
- Gingivoplasties
- Gingivectomies, Gingivectomy in case of hyperplasias of the gingival or excision of hyperplasias
- Gingival troughing for crown impressions
- Hemostasis
- Implant recovery
- Frenectomies and frenotomies
- Fibromatosis (fibroma removal)
- Benign and malignant lesion removal
- Operculectomy
- Oral papillectomies
- Reduction of gingival hypertrophy
- Soft tissue crown lengthening
- Preprosthetic surgery; flabby alveolar ridge, vestibuloplasty, exposure of implants, hyperplasia, epulides, papilomas, fibromatoses, benign growths
- Vestibuloplasty
- Sucular debridement (removal of diseased or inflamed soft tissue in the periodontal pocket to improve clinical indices including gingival index, gingival bleeding index, probe depth, attachment loss and tooth mobility)
Endodontal Applications of Er: YAG Laser Energy:
- Tooth preparation to obtain access to root canal
- Pulpotomy, Pulpotomy as an adjunct to root canal therapy
- Pulp extirpation
- Root canal debridement and cleaning
- Root canal preparation including enlargement
The CO2 laser component is indicated for the incision, excision, cutting, ablation, vaporization, and coagulation of soft tissue in a variety of soft tissue applications, and in oral and maxillofacial surgery and dentistry.
Periodontal Applications of CO2 Laser Energy:
- Removal of diseased or inflamed soft tissue in the periodontal pocket (sulcular debridement)
- Biopsies
- Frenectomy, Frenum release
- Gingivectomy
- Gingivoplasty
- Papillectomy
- Vestibuloplasty
- Hyperplasia
- Operculectorny
- Drainage (abscess)
- Flap surgery
- Fibroma (nonmalignant tumor; mucosa, tongue)
- Epulis (tumor of the gum)
- Aphthous ulcers
- Removal of soft tissue, cysts, and tumors
The OpusDent Family of Dental Laser Systems is comprised of the following main components:
- A light/ laser system console (including software and control electronics) with a control and display panel;
- Delivery devices; and
- One or more attached hand-piece(s).
The provided document is a 510(k) summary for the OpusDent Family of Dental Laser Systems. This type of submission is for demonstrating substantial equivalence to a legally marketed predicate device, not for proving a device meets specific acceptance criteria through a performance study against a defined ground truth.
Therefore, the document does not contain the information requested in the prompt regarding acceptance criteria and a study proving the device meets those criteria. Specifically:
- Acceptance criteria table and reported performance: Not available. The submission focuses on substantial equivalence to predicate devices, not on quantitative performance metrics.
- Sample size and data provenance for a test set: Not applicable as a performance study in this context is not described.
- Number of experts and their qualifications for ground truth: Not applicable.
- Adjudication method for the test set: Not applicable.
- Multi-reader multi-case (MRMC) comparative effectiveness study: Not applicable. This type of study is not found in the document.
- Standalone algorithm performance: Not applicable. The device is a laser system, not an AI algorithm.
- Type of ground truth used: Not applicable.
- Sample size for the training set: Not applicable.
- How ground truth for the training set was established: Not applicable.
The document states that "Review of indications for use and technical characteristics and data provided were used to support the safety and effectiveness and substantial equivalence of the OpusDent Family of Er YAG and CO2/Er.YAG Combination Laser Products". However, it does not detail specific studies or data that would allow for filling out the requested table or answering the specific questions about performance criteria and study methodology.
§ 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.