Search Results
Found 5 results
510(k) Data Aggregation
K Number
K062176Device Name
RELIEF ACP ORAL CARE GEL
Manufacturer
DISCUS DENTAL INC.
Date Cleared
2007-01-10
(163 days)
Product Code
LBH
Regulation Number
872.3260Why did this record match?
Applicant Name (Manufacturer) :
DISCUS DENTAL INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Relief ACP Oral Care Gel is indicated for relief of discomfort from dentin sensitivity. The product works by forming a layer of calcium phosphate and potassium nitrate on teeth.
Device Description
Relief ACP Oral Care Gel
Ask a Question
K Number
K052090Device Name
SPLASH! IMPRESSION MATERIAL DEVICE
Manufacturer
DISCUS DENTAL INC.
Date Cleared
2005-08-05
(3 days)
Product Code
ELW
Regulation Number
872.3660Why did this record match?
Applicant Name (Manufacturer) :
DISCUS DENTAL INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Splash!® Dental Impression Material is intended for use with all crowns, bridges, occlusal and dental implant impression techniques to reproduce the structure of a patient's teeth and gums.
Device Description
Splash!® Dental Impression Material is an addition-reaction base/catalyst polyvinylsiloxane dental impression material. It is available in Regular set or fast-setting Half-time varieties. Both are available in a heavy viscosity and in wild berry flavor, as well as unflavored.
Ask a Question
K Number
K051776Device Name
PROTEGE ULTRASONIC INSERT
Manufacturer
DISCUS DENTAL INC.
Date Cleared
2005-07-13
(12 days)
Product Code
ELC
Regulation Number
872.4850Why did this record match?
Applicant Name (Manufacturer) :
DISCUS DENTAL INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Protégé Ultrasonic Inserts, both 25KHz and 30KHz models, are intended to be used in the handpieces of any magnetostrictive ultrasonic scaler for dental cleaning and the removal of tenacious calculus deposits by application of an ultrasonic vibrating tip to the teeth.
Device Description
Protégé Ultrasonic Insert Devices
Ask a Question
K Number
K040053Device Name
PRECISION VPS IMPRESSION MATERIAL
Manufacturer
DISCUS DENTAL INC.
Date Cleared
2004-03-25
(73 days)
Product Code
ELW
Regulation Number
872.3660Why did this record match?
Applicant Name (Manufacturer) :
DISCUS DENTAL INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Precision VPS Impression Material is intended for use with all crowns, bridges, occlusal and dental impression techniques to reproduce the structure of a patient's teeth and gums.
Device Description
Precision VPS Impression Material is an addition-reaction base/catalyst polyvinylsiloxane dental impression material available in three different viscosities intended for use with all crowns, bridges, occlusal and dental implant impression procedures.
Ask a Question
K Number
K033381Device Name
DISCHEM CHEMICAL PROPORTIONING & DISPENSING SYSTEM FOR USE WITH CETYLCIDE-G CONCENTRATE AND DILUENT, AQUARIUS MODEL
Manufacturer
DISCUS DENTAL INC.
Date Cleared
2004-01-27
(97 days)
Product Code
MED
Regulation Number
880.6885Why did this record match?
Applicant Name (Manufacturer) :
DISCUS DENTAL INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The DisChem™ Chemical Proportioning & Dispensing System, Aquarius model, for use exclusively with Cetlycide-G concentrate and diluent packaged specifically for the DisChem™ system, is intended for dispensing the Cetylcide-G use solution.
Device Description
Not Found
Ask a Question
Page 1 of 1