FDA.reportPublic FDA data

BoneMedik-DM 0.5~1.0mm, 0.25g

Primary DI
08806387897125
Brand
BoneMedik-DM 0.5~1.0mm, 0.25g
Company
Meta Biomed Co., Ltd.
Model
9712
Device description
BoneMedik-DM is a coralline hydroxyapatite and a more active tricalcium phosphate bone grafting material for dental and craniofacial usage. It is comprised of 60% silicon substituted hydroxyapatite and 40% [3-tricalcium phosphate.
Published
2016-09-19
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
LYCBone Grafting Material, Synthetic
NPMBone Grafting Material, Animal Source

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LYCBone Grafting Material, SyntheticDental2
NPMBone Grafting Material, Animal SourceDental2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K080772000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K080772000BONEMEDIK-DMMeta Biomed Co., Ltd.2008-06-03LYC

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08806387897125PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08806387897125088063878971258806387897125

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
688322841
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
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
08806387895190BeneMedik, 1~2mm, 30cc95192016-09-19
08806387895275BeneMedik, 4~6mm, 1cc95272016-09-19
08806387897002BoneMedik-DM, 0.1~0.3mm, 0.25g97002016-09-19
08806387897019BoneMedik-DM, 0.1~0.3mm, 0.5g97012016-09-19
08806387897026BoneMedik-DM, 0.1~0.3mm, 1.0g97022016-09-19
08806387897033Bonemedik-DM, 0.1~0.3mm, 2g97032016-09-19
08806387897040BoneMedik-DM, 0.1~0.3mm, 5g97042016-09-19
08806387897057BoneMedik-DM, 0.1~0.3mm, 10g97052016-09-19
08806387897064BoneMedik-DM 0.3~0.5mm, 0.25g97062016-09-19
08806387897071BoneMedik-DM, 0.3~0.5mm, 0.5g97072016-09-19
08806387897088BoneMedik-DM 0.3~0.5mm, 1.0g97082016-09-19
08806387897095BoneMedik-DM 0.3~0.5mm, 2.0g97092016-09-19
08806387897101BoneMedik-DM, 0.3~0.5mm, 5g97102016-09-19
08806387897118BoneMedik-DM, 0.3~0.5mm, 10g97112016-09-19
08806387897132BoneMedik-DM 0.5~1.0mm, 0.5g97132016-09-19
08806387897149BoneMedik-DM 0.5~1.0mm, 1.0g97142016-09-19
08806387897156BoneMedik-DM 0.5~1.0mm, 2.0g97152016-09-19
08806387897163BoneMedik-DM, 0.5~1mm, 5g97162016-09-19
08806387897170BoneMedik-DM, 0.5~1mm, 10g97172016-09-19
08806387897194BoneMedik-DM 1.0~2.0mm, 0.5g97192016-09-19

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