FDA.reportPublic FDA data

A-Oss®

Primary DI
00814913024271
Brand
A-Oss®
Company
HIOSSEN, INC.
Model
AOSN025LV
Published
2016-09-30
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
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
K151542000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K151542000A-OssHiossen, Inc.2016-08-03NPM

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00814913024271PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00814913024271008149130242718149130242710814913024271

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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
796083090
Device count
1
Lot or batch
true
Serial number
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00810126046888EK MULTI ANGLED ABUTMENTEK17MUA482TH2026-07-31
00810126046895EK MULTI ANGLED ABUTMENTEK17MUA484TH2026-07-31
00810126046901EK MULTI ANGLED ABUTMENTEK17MUA484TH2026-07-31
00810126046918EK MULTI ANGLED ABUTMENTEK30MUA483TH2026-07-31
00810126046925EK MULTI ANGLED ABUTMENTEK30MUA484TH2026-07-31
00810126046932EK MULTI ANGLED ABUTMENTEK30MUA485TH2026-07-31
00810126046949EK MULTI ANGLED ABUTMENTET17MUA482MWH2026-07-31
00810126046956EK MULTI ANGLED ABUTMENTET17MUA482RWH2026-07-31
00810126046963EK MULTI ANGLED ABUTMENTET17MUA483MWH2026-07-31
00810126046970EK MULTI ANGLED ABUTMENTET17MUA483RWH2026-07-31
00810126046987EK MULTI ANGLED ABUTMENTET17MUA484MWH2026-07-31
00810126046994EK MULTI ANGLED ABUTMENTET17MUA484RWH2026-07-31
00810126047007EK MULTI ANGLED ABUTMENTET17MUA485RWH2026-07-31
00810126047014EK MULTI ANGLED ABUTMENTET30MUA483MWH2026-07-31
00810126047021EK MULTI ANGLED ABUTMENTET30MUA483RWH2026-07-31
00810126047038EK MULTI ANGLED ABUTMENTET30MUA484MWH2026-07-31
00810126047045EK MULTI ANGLED ABUTMENTET30MUA484RWH2026-07-31
00810126047052EK MULTI ANGLED ABUTMENTET30MUA485MWH2026-07-31
00810126047069EK MULTI ANGLED ABUTMENTET30MUA485RWH2026-07-31
00810126046871ET III Fixture SA Regular No MountCET3R5018S2026-07-14

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08800045217584Endobon® Bovine Xenograft MoldableMedPark co.,Ltd.NPM2026-06-25
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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
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
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