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Found 13 results
510(k) Data Aggregation
K Number
K984340Device Name
STERNOMEGA TEMPORARY CEMENT AUTOMIX NE, MODEL 220282/220281
Manufacturer
STERNGOLD/IMPLAMED
Date Cleared
1999-01-08
(35 days)
Product Code
EMA
Regulation Number
872.3275Why did this record match?
Applicant Name (Manufacturer) :
STERNGOLD/IMPLAMED
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
SternOmega Temporary Cement Automix NE is indicated for use as a temporary cement for attaching all types of temporaries, e.g. temporary crowns, bridges, and inlays.
Device Description
The SternOmega Temporary Cement Automix NE is an auto-mixing, non-eugenol cement indicated for the temporary bonding of crowns, bridges and inlays.
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K Number
K984341Device Name
STERNVANTAGE VARNISH LC, MODEL 221001
Manufacturer
STERNGOLD/IMPLAMED
Date Cleared
1999-01-08
(35 days)
Product Code
EBI
Regulation Number
872.3760Why did this record match?
Applicant Name (Manufacturer) :
STERNGOLD/IMPLAMED
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
SternVantage Varnish LC is a surface sealing and finishing material for use on polymerized composite surfaces, denture bases, and temporary crowns and bridges.
Device Description
The Stern Vantage Varnish LC material is a single-component, acrylate-based, light-curing surface coating material for dental applications.
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K Number
K983786Device Name
STERNGOLD IMPLAMED WIDE PLATFORM DENTAL IMPLANTS AND RELATED PROSTHETICS AND INSTTUMENTATION
Manufacturer
STERNGOLD/IMPLAMED
Date Cleared
1998-11-13
(17 days)
Product Code
DZE
Regulation Number
872.3640Why did this record match?
Applicant Name (Manufacturer) :
STERNGOLD/IMPLAMED
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Sterngold Implant can be used in dental implant applications for oral rehabilitation of edentulous and partially dentate patients in the maxilla and mandible. Implant retained restorations may consist of single crowns or bridges as well as complete or partial dentures.
Device Description
Device consists of titanium screws, and titanium alloy prosthetics, brass and stainless steel restorative components, and stainless steel and titanium alloy surgical instruments.
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K Number
K982692Device Name
STERNOMEGA BONDING AGENT, STERNOMEGA COMPOSITE LC, STERNOMEGA COMPOMER LC
Manufacturer
STERNGOLD/IMPLAMED
Date Cleared
1998-10-22
(80 days)
Product Code
EBF
Regulation Number
872.3690Why did this record match?
Applicant Name (Manufacturer) :
STERNGOLD/IMPLAMED
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The SternOmega Dental Composite System is indicated for dental filling of cavities.
The SternOmega Composite LC is indicated for filling of all classes of cavities.
The SternOmega Compomer LC is indicated for Class V restorations, cervical abrasions and erosions, Class III restorations, and for restorations of all cavity classes including Classes I and II in deciduous teeth.
The SternOmega Bonding Agent is indicated for all adhesive restorations with compomers and composites, including the SternOmega Composite LC and the SternOmega Compomer LC.
Device Description
The SternOmega Bonding Agent is a light-curing, one-component bonding agent for compomer and composite, which is applied to dentin and enamel. The bonding agent is self-conditioning, having the primer and bonding adhesive in one bottle.
The SternOmega Composite LC is a single-paste, light-curing, radiopaque universal hybrid composite dental filling material indicated for filling all classes of cavities. It is used in conjunction with the SternOmega Bonding Agent.
The SternOmega Compomer LC is a single-paste, light-curing, radiopaque dental filling material indicated for permanent filling of Class III and V cavities, and for temporary filing of Class I and II cavities. It is used in conjunction with the SternOmega Bonding Agent.
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K Number
K982895Device Name
STERNOMEGA COMPOMER CEMENT
Manufacturer
STERNGOLD/IMPLAMED
Date Cleared
1998-10-09
(53 days)
Product Code
EMA
Regulation Number
872.3275Why did this record match?
Applicant Name (Manufacturer) :
STERNGOLD/IMPLAMED
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
SternOmega Compomer Cement Automix is indicated for use in permanent luting of crowns, bridges, inlays and onlays and for luting ceramic crowns, inlays and veneers.
Device Description
The SternOmega Dental Compomer Cement is an auto-mixing, chemical cure, radiopaque cement indicated for the permanent luting of crowns, bridges, inlays and onlays. The cement contains fluoride which is released over time to provide the benefits associated with a fluoride-releasing material.
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K Number
K981516Device Name
STERNGOLD IMPLAMED HEX SCREW IMPLANT TPS COATED STERNGOLD IMPLAMED HEX SCREW IMPLANT HA COATED , REFER TO TABLE 1 IN SUB
Manufacturer
STERNGOLD/IMPLAMED
Date Cleared
1998-05-11
(13 days)
Product Code
DZE
Regulation Number
872.3640Why did this record match?
Applicant Name (Manufacturer) :
STERNGOLD/IMPLAMED
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Sterngold ImplaMed Implant System can be used in dental implant applications for oral rehabilitation of endentulous and partially dentate patients in the maxillae and mandible. Implant retained restoration may consist of single crowns or bridges as well as complete or partial dentures.
Device Description
Sterngold Impla Med Hex Screw Implant, TPS and HA Coated.
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K Number
K962324Device Name
STERNGOLD U-CPF METAL ALLOY (1067800)
Manufacturer
STERNGOLD/IMPLAMED
Date Cleared
1996-07-24
(37 days)
Product Code
EJS
Regulation Number
872.3060Why did this record match?
Applicant Name (Manufacturer) :
STERNGOLD/IMPLAMED
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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K Number
K962325Device Name
QUASAR YELLOW CROWN AND BRIDGE ALLOY (1122015)
Manufacturer
STERNGOLD/IMPLAMED
Date Cleared
1996-07-24
(37 days)
Product Code
EJT
Regulation Number
872.3060Why did this record match?
Applicant Name (Manufacturer) :
STERNGOLD/IMPLAMED
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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K Number
K962326Device Name
STERNGOLD BIO-5 (1127210)
Manufacturer
STERNGOLD/IMPLAMED
Date Cleared
1996-07-24
(37 days)
Product Code
EJT
Regulation Number
872.3060Why did this record match?
Applicant Name (Manufacturer) :
STERNGOLD/IMPLAMED
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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K Number
K962304Device Name
STERNGOLD BIO-4
Manufacturer
STERNGOLD/IMPLAMED
Date Cleared
1996-07-23
(36 days)
Product Code
EJS
Regulation Number
872.3060Why did this record match?
Applicant Name (Manufacturer) :
STERNGOLD/IMPLAMED
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
Ask a Question
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