FDA.reportPublic FDA data

NEOMEM® ECM

Primary DI
M26330074010
Brand
NEOMEM® ECM
Company
DSM BIOMEDICAL, INC.
Model
30074-01
Catalog number
NX1520
Device description
Porcine Extracellular Matrix Dental Membrane
Published
2020-08-25
Public version status
New
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
NPLBarrier, Animal Source, Intraoral

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NPLBarrier, Animal Source, IntraoralDental2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
M26330074010PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Collagen dental regeneration membraneA sterile bioabsorbable material intended to be used to aid in the regeneration of tooth support, lost due to periodontal disease or trauma, and to regenerate bone defects around implants and at sites intended for implant placement, by acting as a barrier to prevent the down-growth of soft tissue into the underlying bone during the healing period. It is a pliable material made of animal-derived collagen (e.g., porcine) which may be fixed to soft tissues with sutures; it is applied between soft tissue and bone during periodontal flap surgery and applied to grafted bone defects in guided bone regeneration (GBR) and guided tissue regeneration (GTR) procedures. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length20Millimeter
Width15Millimeter

Sterilization Methods#

Method table
Method

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
false
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
00812337020039XCM Biologic® Tissue Matrix 30010-03XM106.0204S2015-09-17
00812337020046XCM Biologic® Tissue Matrix 30010-04XM106.0307S2015-09-17
00812337020060XCM Biologic® Tissue Matrix30010-06XM106.0407S2015-09-17
00812337020084XCM Biologic® Tissue Matrix 30010-08XM106.0416S2015-09-17
00812337020091XCM Biologic® Tissue Matrix30010-09XM106.0420S2015-09-17
00812337020114XCM Biologic® Tissue Matrix30010-11XM106.0516S2015-09-17
00812337020138XCM Biologic® Tissue Matrix30010-13XM106.0612S2015-09-17
00812337020145XCM Biologic® Tissue Matrix30010-14XM106.0616S2015-09-17
00812337020152XCM Biologic® Tissue Matrix30010-15XM106.0620S2015-09-17
00812337020190XCM Biologic® Tissue Matrix 30010-19XM106.0812S2015-09-17
00812337020206XCM Biologic® Tissue Matrix30010-20XM106.0816S2015-09-17
00812337020213XCM Biologic® Tissue Matrix30010-21XM106.0820S2015-09-17
00812337020220XCM Biologic® Tissue Matrix30010-22XM106.1016S2015-09-17
00812337020237XCM Biologic® Tissue Matrix30010-23XM106.1020S2015-09-17
00812337020251XCM Biologic® Tissue Matrix30010-25XM106.1220S2015-09-17
00812337020268XCM Biologic® Tissue Matrix 30010-26XM106.1620S2015-09-17
00812337020299XCM Biologic® Tissue Matrix30010-29XM106.1625S2015-09-17
00812337020305XCM Biologic® Tissue Matrix30010-30XM106.2020S2015-09-17
00812337020312XCM Biologic® Tissue Matrix30010-31XM106.2025S2015-09-17
00812337020329XCM Biologic® Tissue Matrix30010-32XM106.2030S2015-09-17

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Primary DI, Brand, Company table
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