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510(k) Data Aggregation
K Number
K250456Device Name
Dentemp Pro-Comfort Dental Guard
Manufacturer
DOC Brands, Inc.
Date Cleared
2025-05-19
(90 days)
Product Code
OBR
Regulation Number
N/AWhy did this record match?
Applicant Name (Manufacturer) :
DOC Brands, Inc.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Dentemp Pro-Comfort is indicated for protection against nighttime teeth grinding (bruxism). It is intended to reduce damage to teeth and prevent the noise associated with teeth grinding and bruxism.
Device Description
Dentemp Pro-Comfort Dental Guard is an over-the-counter device to be used by lay people for protection against the effects of nighttime teeth grinding. It is manufactured with a two-shot, injection molded process. The first shot is a hard base of Ethylene Methyl Acrylate material (EMA), which contacts the lower tooth surfaces during grinding and prevents grind-through. The second shot is a soft, moldable surface layer of Ethylene Vinyl Acetate material (EVA), which is formed to hug the upper teeth for a comfortable fit. It is a custom fit dental guard, formed to an individual user's mouth by the traditional heat and form fitting technique. It is a full-occlusal guard worn on the upper teeth, providing a barrier to separate the upper and lower teeth and keep them apart while sleeping, thus reducing the damage to teeth caused by bruxism and preventing the noise associated with teeth grinding.
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K Number
K222424Device Name
Protect-It Custom Fit Dental Guard
Manufacturer
DOC Brands, Inc.
Date Cleared
2022-10-07
(57 days)
Product Code
OBR
Regulation Number
N/AWhy did this record match?
Applicant Name (Manufacturer) :
DOC Brands, Inc.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Protect-It Custom Fit Dental Guard is indicated for protection against bruxism or nighttime teeth grinding. It is intended to reduce damage to teeth associated with bruxing or nighttime teeth grinding.
Device Description
Protect-It Custom Fit Dental Guard is an over-the-counter device to be used by lay people for protection against the effects of nighttime teeth grinding. It is made of a single thermoplastic resin, ethylene vinyl acetate copolymer, EVA, which is easily molded to the teeth when heated. It is a full-occlusal guard worn on the upper teeth, providing a cushion to separate the upper and lower teeth and keep them apart while sleeping, thus reducing the damage to teeth associated with bruxism.
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