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Found 8 results
510(k) Data Aggregation
K Number
K052699Device Name
VERSA-LINK PORCELAIN BONDING SYSTEM
Manufacturer
SULTAN CHEMISTS, INC.
Date Cleared
2005-11-16
(49 days)
Product Code
KLE
Regulation Number
872.3200Why did this record match?
Applicant Name (Manufacturer) :
SULTAN CHEMISTS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Versa-Link Porcelain Bonding System is indicated for the adhesive cementation/bonding of all-ceramic dental restorations (veneers, inlays, onlays and crowns) composed of feldspathic porcelain, pressed porcelain and in-office machined ceramics.
A secondary indication is for the adhesive repair of fractured or damaged metal-ceramic units intraorally.
Device Description
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K Number
K052409Device Name
SILGIMIX ALGINATE REPLACEMENT IMPRESSION MATERIAL
Manufacturer
SULTAN CHEMISTS, INC.
Date Cleared
2005-10-20
(49 days)
Product Code
ELW
Regulation Number
872.3660Why did this record match?
Applicant Name (Manufacturer) :
SULTAN CHEMISTS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Silgimix™ is indicated for use as a dental impression material. The material is intended primarily for taking impressions for study models, orthodontic models, counter impressions, partial denture impressions and temporary crown fabrication.
Device Description
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K Number
K043054Device Name
GENIE MAGIC MIX ULTRA HYDROPHILIC IMPRESSION MATERIAL
Manufacturer
SULTAN CHEMISTS, INC.
Date Cleared
2005-02-18
(105 days)
Product Code
ELW
Regulation Number
872.3660Why did this record match?
Applicant Name (Manufacturer) :
SULTAN CHEMISTS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Sultan Genie Magic Mix™ Ultra Hydrophilic Impression Material is intended for use as a dental impression material, compatible with all techniques including dual-phase, monophase and dual impression techniques. The material is dispensed from an automatic mixing machine system and placed into dental impression trays (metal or plastic) and is used to accurately reproduce intra-oral structures (teeth & gums) to provide models for study and/or fabrication of prosthetic devices.
Device Description
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K Number
K030414Device Name
GENIE ULTRA HYDROPHILIC IMPRESSION MATERIAL
Manufacturer
SULTAN CHEMISTS, INC.
Date Cleared
2003-04-09
(61 days)
Product Code
ELW
Regulation Number
872.3660Why did this record match?
Applicant Name (Manufacturer) :
SULTAN CHEMISTS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Sultan Genie Ultra Hydrophilic Impression Material is intended for use as a dental impression material. The material is dispensed from an automatic mixing cartridge system and placed into dental impression trays (metal or plastic) and is used to accurately reproduce intra-oral structures (teeth & gums) to provide models for study and/or fabrication of prosthetic devices.
Device Description
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K Number
K020612Device Name
SULTAN SPOROX TEST VIAL, MODEL 75195
Manufacturer
SULTAN CHEMISTS, INC.
Date Cleared
2002-05-07
(71 days)
Product Code
JOJ
Regulation Number
880.2800Why did this record match?
Applicant Name (Manufacturer) :
SULTAN CHEMISTS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Sultan Sporox Test Vials are indicated as a rapid, qualitative method for determining if an effective concentration of hydrogen peroxide is present in Sporox Sterilizing and Disinfecting Soution. The Sporox Test Vials indicate the concentration of hydrogen peroxide but do not confirm disinfection or sterilization.
Device Description
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K Number
K002843Device Name
SULTAN SENSITEMP RESIN TEMPORARY CEMENT, MODEL 70010
Manufacturer
SULTAN CHEMISTS, INC.
Date Cleared
2000-11-15
(64 days)
Product Code
EMA
Regulation Number
872.3275Why did this record match?
Applicant Name (Manufacturer) :
SULTAN CHEMISTS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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K Number
K991509Device Name
PRO-PORTION CLEANER/DISINFECTANT
Manufacturer
SULTAN CHEMISTS, INC.
Date Cleared
1999-07-14
(75 days)
Product Code
LRJ
Regulation Number
880.6890Why did this record match?
Applicant Name (Manufacturer) :
SULTAN CHEMISTS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Pro-Portion is a general-purpose cleaner/disinfectant. Its use is restricted to a health care setting where low and intermediate level disinfection of hard, non-porous surfaces is required. It is intended to be used in a dental office as an instrument ultrasonic cleaning solution. In order to disinfect, a contact time of 10 minutes at 69°F / 20°C is required.
This product may be used to pre-clean or decontaminate of critical or noncritical medical devices prior to sterilization. Must be followed by appropriate terminal sterilization or high-level disinfection process.
Device Description
Pro-Portion is a broad spectrum, multi-purpose ready to use, effective cleaner and disinfectant for use on the surfaces of inanimate objects. Pro-portion will efficiently clean and disinfect, when used as directed, such items as laminated counter tops, dental units, dental instruments, lights, and other inanimate surfaces, including those made of plastics (such as: polycarbonate, polyvinylchloride, polypropylene and polystyrene), nonporous vinyl and upholstery, stainless steel, painted surfaces, Plexiglas, glass, and other hard non-porous surfaces.
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K Number
K971138Device Name
DINABASE (TM)
Manufacturer
SULTAN CHEMISTS, INC.
Date Cleared
1997-07-21
(115 days)
Product Code
EBI, DAT
Regulation Number
872.3760Why did this record match?
Applicant Name (Manufacturer) :
SULTAN CHEMISTS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Intended to reline a denture surface that contacts tissue--for temporary or provisional usage. Not for OTC use.
Device Description
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