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510(k) Data Aggregation
K Number
K120109Device Name
SUPER SEAL TOOTH DESENSITIZER
Manufacturer
PHOENIX DENTAL, INC.
Date Cleared
2012-03-07
(54 days)
Product Code
LBH
Regulation Number
872.3260Why did this record match?
Applicant Name (Manufacturer) :
PHOENIX DENTAL, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
To aid in the relief from dentinal sensitivity caused by cold, heat, acids, sweets, or as the result from dental whitening agents.
Device Description
Super Seal ® Tooth Desensitizer is applied with an applicator by the user to aid in dentinal sensitivity. It contains an organic salt that reacts with the calcium hydroxyapatite in the dentinal tubules. The formation of these calcium oxalate crystals inhibits and blocks fluid flow in the tubules, thereby relieving dentinal sensitivity.
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K Number
K102821Device Name
DISCOVRED
Manufacturer
PHOENIX DENTAL, INC.
Date Cleared
2011-03-11
(164 days)
Product Code
LFC
Regulation Number
872.1740Why did this record match?
Applicant Name (Manufacturer) :
PHOENIX DENTAL, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
DiscovRED™ is indicated for use to detect carious dentin.
Device Description
The product, DiscovRED™, is classified into the Caries Detection Device category of CFR 21, Section 872.1740.
DiscovRED™, as well as the Predicate Device, Caries Detector, is a red dye agent that when applied to the suspected carious areas of the tooth stains the carious dentine.
DiscovRED™ is a caries detector. Both devices have a two year shelf-life.
DiscovRED™ is for Prescription Use only and not over-the-counter use.
The method of operation and placement of DiscovRED™ is similar to that of the Predicate Device, Caries Detector. A drop of the detector is applied to the carious dentine, rinsed with water and air dispersed. The stained carious tissue is then removed with a low speed rotary bur. The process may be repeated until there are no more stainable tissues in the cavity.
DiscovRED™ and the Predicate Device do not involve chemical reactions.
DiscovRED™ and the Predicate Device do not use any power-assisted devices such as optical light emitting or electrical energy forms.
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K Number
K983477Device Name
SUPER SEAL
Manufacturer
PHOENIX DENTAL, INC.
Date Cleared
1998-12-22
(81 days)
Product Code
EJK
Regulation Number
872.3250Why did this record match?
Applicant Name (Manufacturer) :
PHOENIX DENTAL, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Super Seal is a potassium oxalate based film forming acid resistant liner and desensitizer that is indicated for application prior to restoration of exposed dentin.
Device Description
Super Seal is a potassium oxalate based film forming acid resistant liner and desensitizer.
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