FDA.reportPublic FDA data

3D Bond

Primary DI
07290014838062
Brand
3D Bond
Company
AUGMA BIOMATERIALS LTD
Model
DD-100
Published
2024-03-03
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

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LYCBone Grafting Material, SyntheticDental2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K083858000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K083858000BOND BONEAugma Biomaterials, Ltd.2009-03-17LYC

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07290014838062PrimaryGS10
17290014838069Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07290014838062072900148380627290014838062
1729001483806917290014838069

GMDN Terms#

Term, Definition table
TermDefinition
Dental bone void filling material, syntheticA bioabsorbable device made of synthetic material 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 typically made of ceramics (e.g., tricalcium phosphate or hydroxyapatite), sometimes bioactive glasses or bioabsorbable polymers, and used to fill bone cavities and defects to 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.

Regulatory Flags#

DUNS number
533432352
Device count
2
DM exempt
true
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
072900148380003D BondDD2-0502015-09-10
072900148380173D BondDD2-1002015-09-10
07290014838024Bond ApatiteHA-BB-Pack12015-09-10
07290014838116Bond ApatiteHA-BB-LMM-NoEU2026-02-04
07290014838123Bond ApatiteHA-BB-LAM-NoEU2026-02-04
072900148381783D Bond+3D-ND-LMM-NoEU2026-02-04
072900148381853D Bond+3D-ND-LAM-NoEU2026-02-04
072900148381923D Bond+3D-ND-LAA-NoEU2026-02-04
072900148382083D BondDD-100-LMM2026-02-04
072900148382153D BondDD-100-LAM2026-02-04
07290014838031Bond ApatiteHA-BB-Pack1-NoEU2020-11-17
07290014838130Bond ApatiteHA-BB-LAA-NoEU2026-01-15
072900148380553D Bond+3D-ND-050-NoEU2022-06-10
08800026800347Augma ShieldOB232022-06-15
172900148380073D Bond DD2-0502015-09-10
172900148380143D BondDD2-1002015-09-10
17290014838021Bond ApatiteHA-BB-Pack12015-09-10

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00813954028798Dyna-Bone PlugCOLLAGEN MATRIX, INC.LYC2026-07-02
00813954028804Dyna-Bone PlugCOLLAGEN MATRIX, INC.LYC2026-07-02
03700501800440MBCP+®BIOMATLANTELYC2026-06-29
03700501800457MBCP+®BIOMATLANTELYC2026-06-29
03700501800464MBCP+®BIOMATLANTELYC2026-06-29
03700501800471MBCP+®BIOMATLANTELYC2026-06-29
03700501800488MBCP+®BIOMATLANTELYC2026-06-29
03700501800495MBCP+®BIOMATLANTELYC2026-06-29
03700501800693MBCP+®BIOMATLANTELYC2026-06-29
03700501800709MBCP+®BIOMATLANTELYC2026-06-29
03700501800716MBCP+®BIOMATLANTELYC2026-06-29
00813954028767Gibson Healthcare AlloplastCOLLAGEN MATRIX, INC.LYC2026-05-26
00813954028774Gibson Healthcare AlloplastCOLLAGEN MATRIX, INC.LYC2026-05-26
00813954028781Gibson Healthcare AlloplastCOLLAGEN MATRIX, INC.LYC2026-05-26
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
00813954026787SynOss PlugCOLLAGEN MATRIX, INC.LYC2025-09-05
00813954026794SynOss PlugCOLLAGEN MATRIX, INC.LYC2025-09-05
00813909010335Dental Porous Morsels 2x1.5gNOVABONE PRODUCTS, LLCLYC2025-07-17
00813909010328Dental Porous Morsels 2x0.5gNOVABONE PRODUCTS, LLCLYC2025-07-17
00813954027128PLENA PLUGCOLLAGEN MATRIX, INC.LYC2025-07-16
00813954027135PLENA PLUGCOLLAGEN MATRIX, INC.LYC2025-07-16
00813954027050TBS Bone PlugCOLLAGEN MATRIX, INC.LYC2025-05-19
00813954027067TBS Bone PlugCOLLAGEN MATRIX, INC.LYC2025-05-19