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Found 9 results
510(k) Data Aggregation
K Number
K060075Device Name
FIBER-METAL POST
Manufacturer
FOREMOST DENTAL LLC.
Date Cleared
2006-03-30
(79 days)
Product Code
ELR
Regulation Number
872.3810Why did this record match?
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AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Fiber-Metal Post is indicated for use as a root canal post. The post is cemented into the prepared root canal of a tooth to support a permanent restoration.
Device Description
The Fiber-Metal Post consists of central core wires twisted around polymer bristles that extend radially from the core. The post will be available is several sizes (length and OD as measured over the fibers) and configurations based on bristle arrangement (straight or tapered).
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K Number
K042848Device Name
FRC POSTEC PLUS
Manufacturer
IVOCLAR VIVADENT, INC.
Date Cleared
2004-11-22
(38 days)
Product Code
ELR
Regulation Number
872.3810Why did this record match?
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AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Intended for use by dentists to give retention for reconstruction of endontically treated teeth.
Device Description
Not Found
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K Number
K030820Device Name
EVERSTICK POST
Manufacturer
STICK TECH LTD.
Date Cleared
2003-05-20
(67 days)
Product Code
ELR
Regulation Number
872.3810Why did this record match?
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AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Intended for use as a fiber reinforced root canal post
Device Description
everStick™ POST is a semi-manufactured product made of glass fibers and polymer/resin matrix. The glass fiber in everStick™ POST is unidirectional which increases the strength and stiffness of the final product perpendicular to the direction of the fibers.
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K Number
K020431Device Name
FIBIOCORE
Manufacturer
EST. ANTHOGYR
Date Cleared
2002-07-03
(145 days)
Product Code
ELR
Regulation Number
872.3810Why did this record match?
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AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The FIBIOCORE composite posts are intented for use by dentists to give retention for reconstruction of non-vital teeth. The device is intended to be cemented into the root canal of a tooth to stabilize and support a restoration.
Device Description
Glass Fiber composite root canal post
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K Number
K012496Device Name
CARBON POST
Manufacturer
J. MORITA USA, INC.
Date Cleared
2002-05-17
(287 days)
Product Code
ELR
Regulation Number
872.3810Why did this record match?
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AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Carbon Post is a root canal post for use with composite resin cement in a prepared root canal in a non-vital tooth to stabilize and support a restoration.
Device Description
Not Found
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K Number
K013802Device Name
FRC POSTEC
Manufacturer
IVOCLAR VIVADENT, INC.
Date Cleared
2002-05-01
(167 days)
Product Code
ELR
Regulation Number
872.3810Why did this record match?
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Matched: '872.3810'
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
FRC Postec is intended for use by dentists to give retention for reconstruction of endontically treated teeth
Device Description
Not Found
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K Number
K012849Device Name
GLASS POST
Manufacturer
J. MORITA USA, INC.
Date Cleared
2002-03-27
(236 days)
Product Code
ELR
Regulation Number
872.3810Why did this record match?
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Matched: '872.3810'
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Glass Post is a root canal post for use with composite resin cement in a prepared root canal in a non-vital tooth to stabilize and support a restoration.
Device Description
Not Found
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K Number
K012354Device Name
SNOWPOST, SNOWLIGHT
Manufacturer
DANVILLE MATERIALS, INC.
Date Cleared
2001-10-10
(77 days)
Product Code
ELR
Regulation Number
872.3810Why did this record match?
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AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Snowpost & Snowlight posts are indicated for use wherever root canal posts are required Showpost & Showingin posts are mellor and/or where known metal allergies are of concern.
Device Description
Not Found
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K Number
K974649Device Name
BIO-POST DENTAL POST SYSTEM
Manufacturer
ADVANCED AEROMEDICAL, INC.
Date Cleared
1998-05-01
(140 days)
Product Code
ELR
Regulation Number
872.3810Why did this record match?
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AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Bio-Post is a dental root canal post intended to be cemented into the root canal of a tooth to stabilized and support a restoration.
Device Description
The Bio-Post is fabricated from a composite of medical grade continuous glass fibers specifically oriented in a vinyl ester matrix around a surgical grade stainless steel wire. The device is radiopaque, and will be available in standard sizes.
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