FDA.reportPublic FDA data

Regenomer

Primary DI
08809186549455
Brand
Regenomer
Company
Nibec Co., Ltd.
Model
RSP2-L
Device description
Regenomer® is a sponge-like absorbable and porous collagen designed to be used as bone filling augmentation material. The device is manufactured from purified type I collagen derived from porcine skin sources in South Korea. The porcine skin is certified by veterinarian and is obtained by a standardized controlled manufacturing process. Regenomer® is manufactured in three types, Regenomer® Syringe (sheet shape in syringe and blister), Regenomer® Plug (bullet shape in blister), and Regenomer® Block (block shape in blister). Regenomer® are supplied sterile, non-pyrogenic, and for single use only.
Published
2018-08-17
Public version status
New
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
K150079000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K150079000Regenomer® Syringe, Regenomer® Plug, Regenomer® BlockNibec Co., Ltd.2015-12-10NPM

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08809186549455PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08809186549455088091865494558809186549455

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
Device Size Text, specify0

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
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
08809186541329Equimatrix06-60252026-09-29
08809186541336Equimatrix06-60502026-09-29
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08809186541299EquimatrixNibec Co., Ltd.NPM2026-10-06
08809186540926EquimatrixNibec Co., Ltd.NPM2026-09-29
08809186540933EquimatrixNibec Co., Ltd.NPM2026-09-29
08809186540940EquimatrixNibec Co., Ltd.NPM2026-09-29
08809186540957EquimatrixNibec Co., Ltd.NPM2026-09-29
08809186540964EquimatrixNibec Co., Ltd.NPM2026-09-29
08809186540971EquimatrixNibec Co., Ltd.NPM2026-09-29
08809186540988EquimatrixNibec Co., Ltd.NPM2026-09-29
08809186540995EquimatrixNibec Co., Ltd.NPM2026-09-29
08809186541305EquimatrixNibec Co., Ltd.NPM2026-09-29
08809186541312EquimatrixNibec Co., Ltd.NPM2026-09-29
08809186541329EquimatrixNibec Co., Ltd.NPM2026-09-29
08809186541336EquimatrixNibec Co., Ltd.NPM2026-09-29
08800045217584Endobon® Bovine Xenograft MoldableMedPark co.,Ltd.NPM2026-06-25
08800045217591Endobon® Bovine Xenograft MoldableMedPark co.,Ltd.NPM2026-06-25
08800045217607Endobon® Bovine Xenograft MoldableMedPark co.,Ltd.NPM2026-06-25
08800045217614Endobon® Bovine Xenograft MoldableMedPark co.,Ltd.NPM2026-06-25
08800045217621Endobon® Bovine Xenograft MoldableMedPark co.,Ltd.NPM2026-06-25
08800045217638Endobon® Bovine Xenograft MoldableMedPark co.,Ltd.NPM2026-06-25
08800045217645Endobon® Bovine Xenograft MoldableMedPark co.,Ltd.NPM2026-06-25
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