LogoFDA 510(k) Search
K Number
K172223
Device Name
SleepRight ProRx Custom Dental Guard
Manufacturer
Splintek, Inc.
Date Cleared
2017-11-17

(116 days)

Product Code
OBR,MOC
Regulation Number
N/A
Type
Traditional
Panel
DE
Reference & Predicate Devices
K071404,K121272
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

The SleepRight® ProRx® Custom Dental Guard is indicated for the protection against bruxism or nighttime teeth grinding. It is intended to reduce damage to the teeth and to prevent the noise associated with bruxing or grinding.

Protection against teeth grinding, bruxism and jaw clenching.

Short-term pain relief from muscle spasm due to occlusal interference.

For the prevention of chronic tension and temporomandibular joint (TMJ) syndrome that is caused by chronic jaw clenching of the mandibular and maxillary teeth by the temporalis muscle.

Device Description

The SleepRight® ProRx® Custom Dental Guard is a full occlusal custom formable protector that provides a barrier between the upper and lower teeth. Contains a hard core material enveloped by a moldable thermoplastic. The guard is heated in hot (not boiling) water until it becomes malleable and then formed to the consumers upper teeth. To achieve a custom fit, the guard is inserted into the mouth and the side walls are gently pushed up to surround the teeth. The material hardens in roughly one minute. The SleepRight® ProRx® Custom Dental Guard has a tensile strength of 29 Mpa and a Shore D hardness value comparable to the primary predicate device, the ProTech Dent®.

AI/ML Overview

The provided text describes a 510(k) submission for a dental guard. It does not contain information about a medical device that uses artificial intelligence or requires a study with acceptance criteria and reported device performance in the way typically expected for AI/ML-based devices (e.g., sensitivity, specificity, AUC).

Instead, the document details a comparative evaluation of physical properties, wear and abrasion resistance, and biocompatibility of the SleepRight® ProRx® Custom Dental Guard against predicate devices. The "performance data" section states:

  • "Comparative evaluation of the physical properties of the materials of construction of the SleepRight® ProRx® Custom Dental Guard and the primary predicate device, the ProTech Dent®."
  • "Comparative wear and abrasion resistance testing of the SleepRight® ProRx® Custom Dental Guard and the primary predicate device the ProTech Dent®"
  • "Biocompatibility testing: Cytotoxicity (ISO 10993 - 5), Sensitization and Irritation (ISO 10993 - 10)"

The conclusion states that the device "has the same indications for use, same materials of construction, same technological characteristics, and the same principles of operation as the predicate devices," thereby establishing substantial equivalence.

Given this, I cannot provide the requested information formatted for AI/ML device studies because the provided document does not pertain to such a device or study type. The "acceptance criteria" and "device performance" are focused on material properties and biological safety as compared to predicate devices, not on diagnostic accuracy metrics.

N/A