FDA.reportPublic FDA data

Instradent XenoGraft

Primary DI
08809186540483
Brand
Instradent XenoGraft
Company
Nibec Co., Ltd.
Model
I1-0210-025
Device description
Instradent XenoGraft is a sterile, porous bone mineral matrix produced by the removal of the organic compounds from bovine bone. The Instradent XenoGraft contains pure hydroxyapatite derived from bovine bone using a validated the manufacturing process. The large surface area of Instradent XenoGraft is effective for the regeneration of new bone around the grafted bone. The Instradent XenoGraft has good osteoconductivity to enhance new bone formation.
Published
2016-09-23
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

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
K113246000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K113246000OCS-BNibec Company, Limited2013-01-16NPM

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08809186540483PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08809186540483088091865404838809186540483

GMDN Terms#

Term, Definition table
TermDefinition
Dental bone matrix implant, animal-derivedA sterile bioabsorbable device made primarily of animal-derived bone or dentin matrix (e.g., bovine, porcine) implanted into the body to provide osteoconductive bone-tissue scaffolds to replace maxillofacial and/or mandibular bone lost through trauma or dental surgery. It is used to fill bone cavities and defects and contains pores that promote the ingrowth of endogenous bone for skeletal reconstruction and/or augmentation. It is typically provided as sterile cancellous blocks, chips, or granules of varying sizes, or mouldable materials.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Weight0.25Gram

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature15 Degrees Celsius25 Degrees Celsius

Contacts#

Phone, Email table
PhoneEmail
+827050068814webmaster@nibec.co.kr

Regulatory Flags#

DUNS number
687796909
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08809186542036Straumann RegenomerRSP1-S2018-08-17
08809186542043Straumann RegenomerRSP2-L2018-08-17
08809186542050Straumann RegenomerRSB1-S2018-08-17
08809186542067Straumann RegenomerRSB2-L2018-08-17
08809186549424RegenomerRSB1-S2018-08-17
08809186549431RegenomerRSB2-L2018-08-17
08809186549448RegenomerRSP1-S2018-08-17
08809186549455RegenomerRSP2-L2018-08-17
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
08809186540490Instradent XenoGraftI1-0210-0502016-09-23
08809186540506Instradent XenoGraftI1-0210-1002016-09-23
08809186540513Instradent XenoGraftI1-0210-2002016-09-23
08809186540520Instradent XenoGraftI1-1020-0252016-09-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08806387896760Renew-Cera, (BoneMedik-DM 0.3~0.5mm, 0.25g)Meta Biomed Co., Ltd.NPM2022-09-20
08806387896777Renew-Cera, (BoneMedik-DM 0.5~1.0 mm, 0.25g)Meta Biomed Co., Ltd.NPM2022-09-20
08806387896784Renew-Cera, (BoneMedik-DM 1.0~2.0 mm, 0.25g)Meta Biomed Co., Ltd.NPM2022-09-20
08806387896791Renew-Cera, (BoneMedik-DM 0.3~0.5 mm, 0.50g)Meta Biomed Co., Ltd.NPM2022-09-20
08806387896807Renew-Cera, (BoneMedik-DM 0.5~1.0 mm, 0.50g)Meta Biomed Co., Ltd.NPM2022-09-20
08806387896814Renew-Cera, (BoneMedik-DM 1.0~2.0 mm, 0.50g)Meta Biomed Co., Ltd.NPM2022-09-20
08806387896821Renew-Cera, (BoneMedik-DM 0.3~0.5 mm, 1.0g)Meta Biomed Co., Ltd.NPM2022-09-20
08806387896838Renew-Cera, (BoneMedik-DM 0.5~1.0mm, 1.0g)Meta Biomed Co., Ltd.NPM2022-09-20
08806387896845Renew-Cera, (BoneMedik-DM 1.0~2.0 mm, 1.0g)Meta Biomed Co., Ltd.NPM2022-09-20
08806387896852Renew-Cera, (BoneMedik-DM 0.3 ~ 0.5 mm, 2.0g)Meta Biomed Co., Ltd.NPM2022-09-20
08806387896869Renew-Cera, (BoneMedik-DM 0.5~1.0 mm, 2.0g)Meta Biomed Co., Ltd.NPM2022-09-20
08806387896876Renew-Cera, (BoneMedik-DM 1.0~2.0 mm, 2.0g)Meta Biomed Co., Ltd.NPM2022-09-20
08800039000000THE GraftPURGO BIOLOGICS Inc.NPM2018-10-15
08800039000017THE GraftPURGO BIOLOGICS Inc.NPM2018-10-15
08800039000024THE GraftPURGO BIOLOGICS Inc.NPM2018-10-15
08800039000031THE GraftPURGO BIOLOGICS Inc.NPM2018-10-15
08800039000048THE GraftPURGO BIOLOGICS Inc.NPM2018-10-15
08800039000055THE GraftPURGO BIOLOGICS Inc.NPM2018-10-15
08800039000062THE GraftPURGO BIOLOGICS Inc.NPM2018-10-15
08800039000079THE GraftPURGO BIOLOGICS Inc.NPM2018-10-15
08800039000086THE GraftPURGO BIOLOGICS Inc.NPM2018-10-15
08800039000093THE GraftPURGO BIOLOGICS Inc.NPM2018-10-15
08800039000109THE GraftPURGO BIOLOGICS Inc.NPM2018-10-15
08800039000116THE GraftPURGO BIOLOGICS Inc.NPM2018-10-15
08800039000123THE GraftPURGO BIOLOGICS Inc.NPM2018-10-15
08800039000130THE GraftPURGO BIOLOGICS Inc.NPM2018-10-15
08800039000147THE GraftPURGO BIOLOGICS Inc.NPM2018-10-15
08800039000154THE GraftPURGO BIOLOGICS Inc.NPM2018-10-15
08800039000161THE GraftPURGO BIOLOGICS Inc.NPM2018-10-15
08800039000178THE GraftPURGO BIOLOGICS Inc.NPM2018-10-15