Search Filters

Search Results

Found 4 results

510(k) Data Aggregation

    K Number
    K212353
    Device Name
    DB-EZ Bone Void Filler
    Manufacturer
    Dimensional Bioceramics, LLC.
    Date Cleared
    2021-09-22

    (55 days)

    Product Code
    MQV
    Regulation Number
    888.3045
    Why did this record match?
    Applicant Name (Manufacturer) :

    Dimensional Bioceramics, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    DB-EZ Bone Void Filler is indicated to fill bony voids or gaps of the skeletal system (i.e. extremities and pelvis). These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. The device is indicated only for bony voids or gaps that are not intrinsic to the stability of the bony structure. The device provides a bone void filler that resorbs and is replaced by bone during the healing process.
    Device Description
    DB-EZ Bone Void Filler is a pre-mixed moldable and biocompatible putty/paste bone void filler. DB-EZ consists of a mixture of calcium phosphate powder in a bioinert polyethylene glycol (PEG) based polymer that resorbs and is replaced with bone during the healing process.
    Ask a Question
    K Number
    K210193
    Device Name
    DB-Composite
    Manufacturer
    Dimensional Bioceramics, LLC
    Date Cleared
    2021-03-15

    (49 days)

    Product Code
    MQV
    Regulation Number
    888.3045
    Why did this record match?
    Applicant Name (Manufacturer) :

    Dimensional Bioceramics, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    DB-Composite Bone Void Filler is indicated to fill bony voids or gaps of the skeletal system (i.e. extremities, posterolateral spine, pelvis). These defects may be surgically created osseous defects created from traumatic injury to the bone. DB-Composite is indicated only for bony voids or gaps that are not intrinsic to the stability of the bony structure. The product provides a bone void filler that resorbs and is replaced by bone during the healing process.
    Device Description
    DB-Composite Bone Void Filler is a moldable and biocompatible calcium sulfate/calcium phosphate bone void filler. The DB-Composite kit is comprised of two components: A calcium sulfate/calcium phosphate powder mix and a mixing solution in premeasured quantities, which will be mixed together prior to implantation. The 3cc, 5cc, and 10cc DB-Composite Bone Void Filler Kits are provided sterile to SAL 10-6 and are for single use only.
    Ask a Question
    K Number
    K200752
    Device Name
    DB-Orthopedics
    Manufacturer
    Dimensional Bioceramics, LLC
    Date Cleared
    2020-04-22

    (30 days)

    Product Code
    MQV
    Regulation Number
    888.3045
    Why did this record match?
    Applicant Name (Manufacturer) :

    Dimensional Bioceramics, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    DB-Orthopedics Bone Void Filler is indicated to fill bony voids or gaps of the skeletal system (i.e. extremities, spine, pelvis). These defects may be surgically created osseous defects created from traumatic injury to the bone. DB-Orthopedics is indicated only for bony voids or gaps that are not intrinsic to the stability of the bony structure. The product provides a bone void filler that resorbs and is replaced by bone during the healing process.
    Device Description
    DB-Orthopedics Bone Void Filler is a moldable, injectable and biocompatible calcium phosphate bone void filler. The DB-Orthopedics kit is comprised of two components: a calcium-phosphate powder and a mixing solution in premeasured quantities, which will be mixed together prior to implantation. The 3 cc, 5 cc, and 10 cc DB-Orthopedics Bone Void Filler kits are provided sterile to SAL of 10-6 and are for single use only.
    Ask a Question
    K Number
    K182742
    Device Name
    DB-CMF
    Manufacturer
    Dimensional Bioceramics, LLC
    Date Cleared
    2019-06-20

    (265 days)

    Product Code
    GXP
    Regulation Number
    882.5300
    Why did this record match?
    Applicant Name (Manufacturer) :

    Dimensional Bioceramics, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    DB-Cranial is a calcium phosphate bone void filler indicated for the repair or filling of neurosurgical burr holes or other cranial bone defects and craniotomy cuts with a surface area no larger than 25 cm2. DB-Cranial may be used in the restoration or augmentation of bony contours of the cranial bone skeleton.
    Device Description
    DB-Cranial Bone Void Filler is a moldable and biocompatible calcium phosphate bone void filler. DB-Cranial kit is comprised of two components: a calcium-phosphate powder and a mixing solution in premeasured quantities, which will be mixed together prior to implantation. The 3 cc, 5 cc, and 10 cc DB-Cranial Bone Void Filler kits are provided sterile to SAL of 10-6 and are for single use only. The sterilization method is gamma radiation. Sterilization validation is based on ISO 11137-2:2013 (VDMax25). DB-Cranial Bone Void Filler will be labeled with a shelf life of 30 months.
    Ask a Question

    Page 1 of 1