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510(k) Data Aggregation
K Number
K212353Device Name
DB-EZ Bone Void Filler
Manufacturer
Dimensional Bioceramics, LLC.
Date Cleared
2021-09-22
(55 days)
Product Code
MQV
Regulation Number
888.3045Why 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.
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K Number
K210193Device Name
DB-Composite
Manufacturer
Dimensional Bioceramics, LLC
Date Cleared
2021-03-15
(49 days)
Product Code
MQV
Regulation Number
888.3045Why 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.
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K Number
K200752Device Name
DB-Orthopedics
Manufacturer
Dimensional Bioceramics, LLC
Date Cleared
2020-04-22
(30 days)
Product Code
MQV
Regulation Number
888.3045Why 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.
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K Number
K182742Device Name
DB-CMF
Manufacturer
Dimensional Bioceramics, LLC
Date Cleared
2019-06-20
(265 days)
Product Code
GXP
Regulation Number
882.5300Why 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.
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