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510(k) Data Aggregation
K Number
K111816Device Name
EQUIMATRIX
Manufacturer
LUITPOLD PHARMACEUTICALS, INC.
Date Cleared
2011-09-29
(94 days)
Product Code
NPM
Regulation Number
872.3930Why did this record match?
Applicant Name (Manufacturer) :
LUITPOLD PHARMACEUTICALS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
EQUIMATRIX™ cancellous and cortical granules are recommended for:
- Augmentation or reconstructive treatment of the alveolar ridge.
- Filling of infrabony periodontal defects.
- Filling of defects after root resection, apicoectomy, and cystectomy.
- Filling of extraction sockets to enhance preservation of the alveolar ridge.
- Elevation of the maxillary sinus floor.
- Filling of periodontal defects in conjunction with products intended for Guided Tissue Regeneration (GTR) and Guided Bone Regeneration (GBR).
- Filling of peri-implant defects in conjunction with products intended for Guided Bone Regeneration (GBR).
Device Description
EquiMatrix™ is a sterile, natural, non-antigenic, porous bone mineral matrix produced by the removal of organic compounds from equine bone. Due to its natural structure EquiMatrix™ is physically and chemically comparable to the mineralized matrix of human bone. The anorganic bone matrix of EquiMatrix™ has a macro and microporous structure similar to human bone. The formation and in-growth of new bone at the implantation site of EquiMatrix™ is favored due to its trabecular architecture, interconnecting macro and micro pores, and its natural consistency. It is supplied as cancellous (spongiosa) or cortical granules in a single use container, packaged in a secondary thermoform blister, and sterilized by v-irradiation.
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K Number
K990537Device Name
OSTEO-PIN MEMBRANE FIXATION PIN
Manufacturer
LUITPOLD PHARMACEUTICALS, INC.
Date Cleared
1999-11-19
(273 days)
Product Code
LYC
Regulation Number
872.3930Why did this record match?
Applicant Name (Manufacturer) :
LUITPOLD PHARMACEUTICALS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
OSTEO-PIN is used to attach absorbable and non-absorbable membranes used for guided tissue regeneration and guided bone regeneration to underlying bone.
Device Description
Not Found
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