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General Usage: Cleaning of Tooth Surfaces Stain Removal from Tooth Surfaces Removal of Surface Deposits from Toeth Cleaning of Dental Pits and Fissures Microciching of enamel and dentin surfaces in preparation for adhesive bonding procedures Microciding of enamer and deching and etching) of metallic, ceramic, composite and actylic surfaces for dental procedures including bonding, cementation, repair and restoration Delivers a controlled stream of particles for the removal of tooth structure Specific Dental Usage: Preparation of tooth surfaces for sealants Preparation of tooth surfaces for orthodontic bracket bonding Preparation of tooth surfaces for bonding bridges Preparation of internal root surfaces for post procedures (after root canal therapy) I reparation of tooth surfaces for adhesive bonding procedures, ceramic inlays, crowns and bridges Preparation of root surfaces for periodontal procedures Repair of composite, acrylic and ceramic restorations Occlusal adjustments and equilibration Repair of prosthetic appliances Bonded splint procedures Removal of cement from temporary and permanent procedures Class I-V cavity preparation NOT FOR USE ON AMALGAM

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This document is a 510(k) clearance letter for the BioStar Airbrator (trade name SIMPLEX™ AIRBRATOR™). It primarily lists the device's intended uses and confirms its substantial equivalence to a predicate device. It does not contain information about acceptance criteria or a study proving the device meets said criteria.

Therefore, I cannot provide the requested information from this document.

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General Usage:

For the absorption/Collection and removal of excessive saliva during dental procedures.

For the absorption/Collection and removal of saliva when excessive saliva is seen collecting in the mouth.

For the absorption/Collection and removal of saliva in General Pediatric Use.

For the absorption/Collection and removal of saliva whenever a potential choking hazard exists with commonly used saliva absorbers.

For the absorption and removal of saliva when typical "suction" type devices are not appropriate or effective. ...

For the collection of saliva when other absorber devices or suction devices are not appropriate or tolerated easily by the patient.

SIMPLEX™ SALIVA ABSORBER/COLLECTOR

I am sorry, but the provided text is a letter from the FDA to a medical device manufacturer, discussing the substantial equivalence of a device (Simplex Saliva Absorber/Collector) to pre-existing devices. It explicitly states that the device is of regulatory class I.

Therefore, the document does not contain information about:

• Acceptance criteria and reported device performance.
• A study proving the device meets acceptance criteria.
• Sample sizes for test sets or training sets.
• Data provenance or adjudication methods.
• Expert qualifications or number of experts used to establish ground truth.
• Multi-reader multi-case comparative effectiveness studies or standalone algorithm performance.
• The type of ground truth used.

The letter is a regulatory approval document based on substantial equivalence to a predicate device, not a detailed technical study report.

Ask a specific question about this device