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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.

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The OpusDuo EC Dental Laser System is intended to aid during dental procedures performed either in hard or soft oral tissue.
The Er: YAG laser component is indicated for caries removal, cavity preparation, enamel etching and the, incision, excision, cutting, ablation, vaporization, and coagulation of soft tissue in oral and maxillofacia! surgery and dentistry. These include the following:
Soft tissue and periodontal indications: Excisional and incisional biopsies; Exposure of unerupted 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, hyperplasias, epulides, papilomas, fibromatoses, benign growths; Vestibuloplasty; Sulcular 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: Tooth preparation to obtain access to root canal; Pulpotomy; Pulp extirpation; Pul potomy as an adjunct to root canal therapy; Root canal debridement and cleaning; Root canal preparation including enlargement
The CO2 laser component is indicated for periodontal procedures such as removal of diseased or inflamed soft tissue in the periodontal pocket (sulcular debridement) and vaporization, excision coagulation and ablation of oral soft tissue in procedures such as gingivectorny; frenum release; removal of soft tissue, cysts and tumors.

The OpusDuo EC is a model of the Opus 20 Dental Laser System, which is intended to aid during dental procedures performed either in hard or soft oral tissue. This is a dual laser system incorporating an Er:YAG laser and a CO2 laser. The system is operating at a wavelength of 2.94 microns and 10.6 microns respectively. The Er: YAG laser delivers to the tissue pulses with energies up to 1 joule per pulse and power up to 12 Watts. The CO2 laser delivers to the tissue power in continuous mode (CW) up to 10 Watts and pulses (SP) up to 6 Watts.

The provided text is a 510(k) Summary for the OpusDuo EC Dental Laser System, which focuses on demonstrating substantial equivalence to predicate devices rather than presenting a study with specific acceptance criteria and detailed performance metrics. As such, it does not contain the information required to populate a table of acceptance criteria and reported device performance directly from a study.

The document primarily relies on comparing the device's technical characteristics, intended use, and indications for use to previously cleared devices. It states that "The OpusDuo EC intended use and indications for use were previously cleared by FDA for the predicate devices" and that the "technical characteristics... are basically the same as those of the cleared..." predicate devices. It also mentions that "Laser output values of the OpusDuo EC are well within previous cleared values of the predicate devices as described."

The closest the document comes to mentioning performance criteria and validation is:

• Performance Standards: The device complies with U.S. Federal Performance Standards 21 CFR 1040.10 and 21 CFR 1040.11 for Class IV Laser Products, and voluntary standards EN 60601-1, EN 60601-1-2, EN-601-2-22, EN-60825-1, CISPR 11: 1997, class B and IEC 61000-4-2/3/4/5: 1995, EMI -EN55011 :1991, IEC 801:1991. These standards cover aspects like electrical safety, electromagnetic compatibility, and laser safety features (interlock protective housing, laser emission indicators, etc.).
• Validation Testing: "Validation testing has confirmed that the design of the additional accessories, which are required for the new applications, satisfies their technical specification." This indicates accessory validation, not necessarily the clinical or diagnostic performance of the laser system itself for its stated indications.

Given this context, I cannot generate the requested table and detailed study information as it is not present in the provided text. The document's purpose is to establish substantial equivalence for market clearance, not to detail a clinical performance study with acceptance criteria, ground truth, and expert adjudication.

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