Search Results

1. Dental Soft Tissue Indications
   incision, excision, vaporization and coagulation of oral soft-tissues including marginal and interdental gingival and epithelial lining of free gingiva and the following specific indications:

• Excisional and incisional biopsies
• Exposure of unerupted teeth
• Fibroma removal
• Frenectomy
• Frenotomv
• Gingival troughing for crown impressions
• Gingivectomy
• Gingivoplasty
• Gingival incision and excision
• Hemostasis and coagulation
• Implant recovery
• Incision and drainage of abscess
• Leukoplakia
• Operculectomy
• Oral papillectomies
• Pulpotomy
• Pulpotomy as an adjunction to root canal therapy
• Reduction of gingival hypertrophy
• Soft-tissue crown lengthening
• Treatment of canker sores, herpetic and aphthous ulcers of the oral mucosa
• Vestibuloplasty
• Tissue retraction for impression
• Reduction of bacterial level (decontamination) and inflammation

2. Laser Periodontal Procedures

• Laser soft-tissue curettage
• Laser removal of diseased, inflamed and necrosed soft-tissue within periodontal pocket - Sulcular debridement (removal of diseased, inflamed and necrosed soft-tissue within periodontal pocket to improve clinical indices including gingival bleeding index, probe depth, attachment loss and tooth mobility).

3. Whitening

• Light activation for bleaching materials for teeth whitening
• Laser-assisted whitening/bleaching of teeth

4. Pain Therapy

• Topical heating for the purpose of elevating tissue temperature for a temporary relief of minor muscle and joint pain and stiffness, minor pain, or muscle spasm, minor sprains and strains, and minor muscular back pain; the temporary increase in local blood circulation; the temporary relaxation of muscle.

Primo Dental Laser is a laser medical device with surgical and therapeutic effects mainly used in dental and oral care. It's a portable medical device composed by a console, the principal component of the device, connected to a handpiece through an optical fiber, which represent the applied parts.
Primo Dental Laser is a medical device used for a great variety of dental treatment including Surgery, Decontamination, Biostimulation and Therapy. All this due to the selection of protocols favourable through a wide spectrum of specialties.
Laser radiation is produced by a laser diode. This component, a semiconductor, is able to produce a laser radiation with a wavelength characteristic of the semiconductor itself.
Primo Dental Laser has the following characteristics: is transportable and equipped with an internal battery to be independent from the power supply. Laser emission occurs with a wireless pedal control, also powered by batteries.
The radiation emitted by the diode laser is delivered to the optical fiber or through the use of an accessory.

I am sorry, but the provided text focuses on the FDA's 510(k) clearance for the "Primo Dental Laser" and its substantial equivalence to predicate devices. It does not contain specific acceptance criteria, performance data, or details about a study designed to prove the device meets those criteria in the context of an AI/ML device.

The document is a regulatory submission for a medical device (a dental laser), not an AI/ML driven diagnostic or therapeutic device that would typically have the kind of acceptance criteria and performance study details you are requesting (e.g., sample sizes for test/training sets, expert ground truth, MRMC studies, standalone performance).

Instead, it discusses:

• Device Description: The nature of the Primo Dental Laser (a portable laser device for dental and oral care).
• Indications for Use: A comprehensive list of dental procedures the laser is intended for.
• Predicate Devices: Comparison of the Primo Dental Laser to other legally marketed dental lasers (Epic 980, QuickLase, SIROLaser Blue, Epic Pro 940, ELUMI 810 + 980 Soft Tissue Laser) to establish substantial equivalence.
• Technological Comparison: Highlights similarities in laser medium, wavelengths, power, operation modes, delivery systems, and compliance with standards.
• Non-Clinical Testing: Mentions biocompatibility testing, electrical safety, electromagnetic compatibility (EMC), and software verification and validation.
• Clinical Testing: Explicitly states that "Clinical testing was not performed since there was no change to the intended use and indications for use and the performance characteristics between the subject device and its predicates."

Therefore, I cannot fulfill your request for the specific details regarding acceptance criteria and performance study data as these are not present in the provided text for this particular device.

Ask a specific question about this device