FDA.reportPublic FDA data

DSM Biomedical Dental Bone Graft

Primary DI
M263300700907
Brand
DSM Biomedical Dental Bone Graft
Company
DSM BIOMEDICAL, INC.
Model
30070-09
Device description
Porcine Anorganic Dental Bone Graft
Published
2021-10-20
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
NPMBone Grafting Material, Animal Source

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NPMBone Grafting Material, Animal SourceDental2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
M263300700907PrimaryHIBCC0

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0

Regulatory Flags#

DUNS number
131107757
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
true
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
M263W25000WizardBio Resorbable Calcium Phosphate Cement21004-05W250002019-01-02
00812337020442Drillable Bone Void Filler21005-0307.705.003S2023-01-11
00812337020459Drillable Bone Void Filler21005-0507.705.005S2023-01-11
00812337020466Drillable Bone Void Filler21005-1007.705.010S2023-01-11
M26300110301005CopiOs® Bone Void Filler Sponge20101-0200-1103-010-052015-09-17
M26300110301010CopiOs® Bone Void Filler Sponge20101-0300-1103-010-102015-09-17
M26300110302001CopiOs® Bone Void Filler Paste20102-0100-1103-020-012015-09-17
M26300110302005CopiOs® Bone Void Filler Paste20102-0200-1103-020-052015-09-17
M26300110302010CopiOs® Bone Void Filler Paste20102-0300-1103-020-102015-09-17
M2630011301001CopiOs® Bone Void Filler Sponge20101-0100-1103-010-012015-09-17
M2630700582001CopiOs® Bone Void Filler Sponge20100-0107.00582.0012015-09-17
M2630700582003CopiOs® Bone Void Filler Sponge20100-0207.00582.0032015-09-17
M2630700582004CopiOs® Bone Void Filler Sponge20100-0307.00582.0042015-09-17
00812337020435BoneSync Fast-Setting Drillable Calcium Phosphate Cement, 1cc21003-04ABS-31012023-05-09
M263300700402DSM Biomedical Dental Bone Graft30070-042021-10-20
M263300700503DSM Biomedical Dental Bone Graft30070-052021-10-20
M263300700604DSM Biomedical Dental Bone Graft30070-062021-10-20
M263300700705DSM Biomedical Dental Bone Graft30070-072021-10-20
M263300700806DSM Biomedical Dental Bone Graft30070-082021-10-20
00812337020244SalvinOSS Collagen Xenograft and Collagen Bone Graft Material30069-022021-01-15

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Primary DI, Brand, Company table
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00614950028511OUSIA bioXENACE SURGICAL SUPPLY CO., INC.NPM2023-06-15
00813954025315RegenerOssCOLLAGEN MATRIX, INC.NPM2023-01-06
00813954025322RegenerOssCOLLAGEN MATRIX, INC.NPM2023-01-06
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