Equimatrix

Primary DI
08809186541329
Brand
Equimatrix
Company
Nibec Co., Ltd.
Model
06-6025
Device description
Equimatrix® is a natural non-antigenic porous bone mineral matrix produced by the removal of all organic components from equine bone. The macro and microporous structure of Equimatrix® is physically and chemically comparable to the mineralized matrix of human bone. Equimatrix® is available in cancellous granules.
Published
2026-09-29
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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K111816000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K111816000EQUIMATRIXLuitpold Pharmaceuticals, Inc.2011-09-29NPM

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08809186541329PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08809186541329088091865413298809186541329

GMDN Terms#

Term, Definition table
TermDefinition
Dental bone void filling material, animal-derivedA bioabsorbable, implantable device made primarily of animal-derived materials (e.g., bovine, porcine) intended to replace maxillofacial and/or mandibular bone lost through trauma or dental surgery. Also referred to as a graft, matrix, or void filler, it typically provides an osteoconductive scaffold that promotes bone growth, and is used to fill bone cavities and defects. It is typically provided as cancellous blocks, chips, or granules of varying sizes, or mouldable materials.

Regulatory Flags#

DUNS number
687796909
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
true
Manufacturing date on label
true
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
08809186541299Equimatrix08-30502026-10-06
08809186540926Equimatrix06-00252026-09-29
08809186540933Equimatrix06-00502026-09-29
08809186540940Equimatrix06-01002026-09-29
08809186540957Equimatrix06-02002026-09-29
08809186540964Equimatrix06-10252026-09-29
08809186540971Equimatrix06-10502026-09-29
08809186540988Equimatrix06-11002026-09-29
08809186540995Equimatrix06-12002026-09-29
08809186541305Equimatrix06-40252026-09-29
08809186541312Equimatrix06-40502026-09-29
08809186541336Equimatrix06-60502026-09-29
08809186540179OCS-B1-0210-0252016-09-22
08809186540186OCS-B1-0210-0502016-09-22
08809186540193OCS-B1-0210-1002016-09-22
08809186540209OCS-B1-0210-2002016-09-22
08809186540223OCS-B1-1020-0252016-09-22
08809186540230OCS-B1-1020-0502016-09-22
08809186540247OCS-B1-1020-1002016-09-22
08809186540254OCS-B1-1020-2002016-09-22

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Primary DI, Brand, Company table
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00813954026190REGENAFILLCOLLAGEN MATRIX, INC.NPM2024-06-21
00813954026138EvoBone PlugCOLLAGEN MATRIX, INC.NPM2024-03-28
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