(175 days)
The Urbanek Device is for the amelioration of clenching and bruxing associated with TMD and is to aid in the relief of symptoms of TMD/TMJ.
The Urbanek Device is an intraoral, maxillary posterior dis-occluding device designed to aid in the treatment of clenching and bruxing associated with TMD/TMJ. The purpose of the device is to keep posterior maxillary and mandibular teeth (molars and premolars) from occluding in the centric or eccentric positions. Constructed of heat cured dental resin and two metal ball clasps for retention, the device is customized for each patient (per prescription by a dentist). The device is designed to be worn for 24 hours per day (except at meals), 7 days per week for a set interval of time (e.g., 9 weeks). At scheduled follow-up visits, patients are assessed for symptom relief and the device inspected for comfort, proper design, excessive wear and vertical dimension for the inter-incisal distance with the device in place. The device may be adjusted for comfort and inter-incisal distance to ensure no posterior tooth or portion of a tooth occludes with the opposing tooth.
The provided text does not contain information about acceptance criteria and a study to prove the device meets those criteria. Instead, it describes a substantial equivalence determination for the "Urbanek Device" (K170985) against predicate devices (NTI-TSS NTI Tension Suppression System and MigraTherapy LLC Brux-TMD QuickSplint).
The document explicitly states:
Performance Testing: "Performance testing has not been performed as there are no recognized standards to which prescription mouthguards are tested; however, the material composition of the Urbanek Device base has been found in legally marketed devices and found previously safe for dental use since 2001 and meets the requirements of ISO 20795-1:2008 Dentistry -- Base polymers -- Part I: Denture base polymers (previously ISO 1567:1999)."
Therefore, I cannot provide the requested information. The device's clearance was based on its substantial equivalence to previously cleared devices, particularly regarding its materials and mechanism of action (disocclusion), rather than specific performance testing demonstrating fulfillment of a set of acceptance criteria.
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