FDA.reportPublic FDA data

SynthoGraft

Primary DI
10813110026672
Brand
SynthoGraft
Company
BICON, LLC
Model
260-400-150
Catalog number
260-400-150
Device description
0.5g SynthoGraft (50-500um)
Published
2016-03-07
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

Contact Domains#

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
K051091000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K051091000SYNTHOGRAFTBicon, Inc.2005-09-01LYC

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10813110026672PrimaryGS10
00813110026675Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1081311002667210813110026672
00813110026675008131100266758131100266750813110026675

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.

Contacts#

Phone, Email table
PhoneEmail
617-524-4443support@bicon.com

Regulatory Flags#

DUNS number
945015758
Device count
5
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
false
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
10813110026665SynthoGraft260-400-125260-400-1252016-03-07
10813110026689SynthoGraft260-400-151260-400-1512016-03-07
10813110026696SynthoGraft260-400-152260-400-1522016-03-07
10813110026702SynthoGraft260-400-500260-400-5002016-03-07
10813110026719SynthoGraft260-400-501260-400-5012016-03-07
10813110026726SynthoGraft260-400-502260-400-5022016-03-07
10813110026733SynthoGraft260-400-525260-400-5252016-03-07
00813110029782Pliers260-801-070260-801-0702026-01-01
00813110029799Pliers260-801-075260-801-0752026-01-01
00813110029805Forceps Tips260-801-080260-801-0802026-01-01
00813110029812Forceps Tips260-801-085260-801-0852026-01-01
00813110028105Scan Body260-100-640260-100-6402020-03-24
00813110029744Scan Post260-100-810260-100-8102024-10-21
00813110029751Scan Post260-100-820260-100-8202024-10-21
00813110029768Scan Post260-100-830260-100-8302024-10-21
00813110027306Scan Post260-100-610260-100-6102016-05-06
00813110027313Scan Post260-100-620260-100-6202016-05-06
00813110027320Scan Post260-100-630260-100-6302016-05-06
00813110027276Universal Abutment260-365-790260-365-7902024-10-21
00813110027283Universal Abutment260-365-795260-365-7952024-10-21

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
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
00813954027074TBS Bone PlugCOLLAGEN MATRIX, INC.LYC2025-05-19
00813954027081TBS Bone PlugCOLLAGEN MATRIX, INC.LYC2025-05-19
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