FDA.reportPublic FDA data

BoneMedik-DM, 1.0~2.0mm, 2.0g

Primary DI
08806387897217
Brand
BoneMedik-DM, 1.0~2.0mm, 2.0g
Company
Meta Biomed Co., Ltd.
Model
9721
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
true
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
08806387897217PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08806387897217088063878972178806387897217

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
08809263708607MX 02-1508602026-10-28
08809263708614MX 02-2008612026-10-28
08809263708621MX 02-2508622026-10-28
08809263708638MX 02-3008632026-10-28
08809263708645MX 02-3508642026-10-28
08809263708652MX 02-4008652026-10-28
08809263708720MX 04-1508722026-10-28
08809263708737MX 04-2008732026-10-28
08809263708744MX 04-2508742026-10-28
08809263708751MX 04-3008752026-10-28
08809263708768MX 04-3508762026-10-28
08809263708775MX 04-4008772026-10-28
08809263708843MX 06-1508842026-10-28
08809263708850MX 06-2008852026-10-28
08809263708867MX 06-2508862026-10-28
08809263708874MX 06-3008872026-10-28
08809263708881MX 06-3508882026-10-28
08809263708898MX 06-4008892026-10-28
08809263708904MG 02-1508902026-10-28
08809263708911MG 02-2008912026-10-28

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07290014838116Bond ApatiteAUGMA BIOMATERIALS LTDLYC2026-02-04
07290014838123Bond ApatiteAUGMA BIOMATERIALS LTDLYC2026-02-04
072900148381783D Bond+AUGMA BIOMATERIALS LTDLYC2026-02-04
072900148381853D Bond+AUGMA BIOMATERIALS LTDLYC2026-02-04
072900148381923D Bond+AUGMA BIOMATERIALS LTDLYC2026-02-04
072900148382083D BondAUGMA BIOMATERIALS LTDLYC2026-02-04
072900148382153D BondAUGMA BIOMATERIALS LTDLYC2026-02-04
07290014838130Bond ApatiteAUGMA BIOMATERIALS LTDLYC2026-01-15
00813909010335Dental Porous Morsels 2x1.5gNOVABONE PRODUCTS, LLCLYC2025-07-17
00813909010328Dental Porous Morsels 2x0.5gNOVABONE PRODUCTS, LLCLYC2025-07-17
00813909013367Dental Putty Cartridge 2 x 0.5ccNOVABONE PRODUCTS, LLCLYC2025-04-25
00813909013374Dental Putty Cartridge 6 x 0.5ccNOVABONE PRODUCTS, LLCLYC2025-04-25
00813909013473PerioGlas - 2 x 0.5ccNOVABONE PRODUCTS, LLCLYC2025-04-25
00813909013480PerioGlas 6 x 0.5ccNOVABONE PRODUCTS, LLCLYC2025-04-25
00813909013503Dental Putty - 6 x 0.5ccNOVABONE PRODUCTS, LLCLYC2025-04-25
00813909013510Dental Putty Cartridge 4 x 0.25ccNOVABONE PRODUCTS, LLCLYC2025-04-25
00813909013329Dental Putty Syringe 0.5ccNOVABONE PRODUCTS, LLCLYC2025-04-25
00813909013336Dental Putty Syringe 1.0ccNOVABONE PRODUCTS, LLCLYC2025-04-25
00813909013343Dental Putty Syringe 2.0ccNOVABONE PRODUCTS, LLCLYC2025-04-25
00813909013497Dental Putty 0.5ccNOVABONE PRODUCTS, LLCLYC2025-04-25
00386040015243FoundationGc America Inc.LYC2024-03-12
00386040015250FoundationGc America Inc.LYC2024-03-12
072900148380623D BondAUGMA BIOMATERIALS LTDLYC2024-03-03
00614950028443OUSIA bioXENACE SURGICAL SUPPLY CO., INC.NPM2023-06-15
00614950028450OUSIA bioXENACE SURGICAL SUPPLY CO., INC.NPM2023-06-15
00614950028467OUSIA bioXENACE SURGICAL SUPPLY CO., INC.NPM2023-06-15
00614950028474OUSIA bioXENACE SURGICAL SUPPLY CO., INC.NPM2023-06-15
00614950028481OUSIA bioXENACE SURGICAL SUPPLY CO., INC.NPM2023-06-15
00614950028498OUSIA bioXENACE SURGICAL SUPPLY CO., INC.NPM2023-06-15
00614950028504OUSIA bioXENACE SURGICAL SUPPLY CO., INC.NPM2023-06-15