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510(k) Data Aggregation
K Number
K142130Device Name
ORAL BOND
Manufacturer
Date Cleared
2016-06-06
(672 days)
Product Code
Regulation Number
872.3275Why did this record match?
Applicant Name (Manufacturer) :
STEINER LABORATORIES
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Oral Bond is indicated to be used as an adjunct to temporally assist in securing periodontal dressings.
Device Description
Oral Bond is a sterile, liquid dental cement containing a monomeric (2-octyl cyanoacrylate) formulation with a viscosity increasing agent, stabilizer, and colorant (D&C Violet #2 or D&C Yellow #10) . Oral Bond is supplied in a multiuse vial. The liquid is syrup-like in viscosity and polymerizes within seconds after contact with water.
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K Number
K113049Device Name
SOCKET GRAFT
Manufacturer
Date Cleared
2012-01-27
(106 days)
Product Code
Regulation Number
872.3930Why did this record match?
Applicant Name (Manufacturer) :
STEINER LABORATORIES
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
SOCKET GRAFT is a bone grafting material indicated for use in dental extraction sockets that have all walls remaining. Socket Seal is a temporary implantable material intended for use in the oral cavity to be used as a space maintaining barrier over bone and other tissue. Socket Seal is indicated for use over bone grafts. Socket Seal in indicated for use over extraction sockets in the maxilla and mandible.
Device Description
SOCKET GRAFT is intended to regenerate bone in dental extraction sockets. SOCKET GRAFT is dual phase calcium phosphate biocement that is wetted by sterile water to a putty consistency. Extraction sockets are filled with SOCKET GRAFT and covered by the enclosed Socket Seal. SOCKET GRAFT is fully resorbed in 12-14 weeks resulting the extraction socket. SOCKET GRAFT is supplied in sterile, single use 1.5 cc syringes. Socket Seal is a closed cell, medical grade, polyethylene foam material that is a nonporous, biocompatible semi-rigid sheet. Socket Seal is designed to stabilize, support and protect bone graft material and provide space maintenance for regenerative healing.
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K Number
K101718Device Name
OSSEOCONDUCT
Date Cleared
2010-10-26
(130 days)
Product Code
Regulation Number
872.3930Why did this record match?
Applicant Name (Manufacturer) :
STEINER LABORATORIES DIV OF STEINER HEALTHCARE LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
OsseoConduct is intended to fill, augment, or reconstruct periodontal or bony defects of the oral and maxillofacial region. Specifically, for the augmentation of deficient maxillary and mandibular alveolar ridges and the treatment of oral, maxillofacial and dental intraosseous defects including ridge augmentation, sinus lifts, craniofacial augmentation, filling of defects of endodontic origin, filling of cystic defects, filling of extraction sites, filling of lesions of periodontal origin, repair of traumatic defects of the alveolar ridge, filling of resection defects from bone tumors, cysts or other osseous defects, and a substitute for autogenous or allogenic bone grafts.
Device Description
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K Number
K063010Device Name
REGEN BIOCEMENT
Manufacturer
Date Cleared
2006-11-28
(57 days)
Product Code
Regulation Number
872.3930Why did this record match?
Applicant Name (Manufacturer) :
STEINER LABORATORIES
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
REGEN BIOCEMENT is intended to be used as a bone grafting material in the maxillofacial region.
Device Description
Not Found
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K Number
K052493Device Name
SOCKET GRAFT
Manufacturer
Date Cleared
2006-06-09
(270 days)
Product Code
Regulation Number
872.3930Why did this record match?
Applicant Name (Manufacturer) :
STEINER LABORATORIES
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Bone void filler for use in dental extraction sockets
Device Description
Not Found
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