FDA.reportPublic FDA data

Dental Putty Cartridge 4 x 0.25cc

Primary DI
00813909013572
Brand
Dental Putty Cartridge 4 x 0.25cc
Company
NOVABONE PRODUCTS, LLC
Model
ND4640
Catalog number
ND4640
Device description
Synthetic bone void filler for dental applications
Published
2025-04-25
Public version status
New
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

Product Code Classifications#

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K100671000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K100671000NOVABONE DENTAL PUTTY-BIOACTIVE SYNTHETIC BONE GRAFTNovabone Products, LLC2010-03-30LYC

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00813909013510PrimaryGS10
00813909013572Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00813909013510008139090135108139090135100813909013510
00813909013572008139090135728139090135720813909013572

GMDN Terms#

Term, Definition table
TermDefinition
Dental bone matrix implant, syntheticA sterile 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.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature0 Degrees Celsius40 Degrees Celsius

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
828813290
Device count
4
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
00813909014036Putty 2.5ccVIDROP002NB0602SE2026-09-10
00813909014043Putty 5.0ccVIDROP005NB0605SE2026-09-10
00813909014050Putty 10.0ccVIDROP010NB0610SE2026-09-10
00813909014067Bioactive Strip 5.0ccVIDROS005NB2305SE2026-09-10
00813909014074Bioactive Strip 10.0cc LongVIDROS010NB2310LSE2026-09-10
00813909014081Putty MIS Refill 5.0ccVIDROG005NB6650SE2026-09-10
00813909014098Putty MIS System 10.0ccVIDROG010NB6710SE2026-09-10
00813909010335Dental Porous Morsels 2x1.5gEU0822EU08222025-07-17
00813909012292Dental Porous Morsels 2x1.5gNA0822NA08222021-04-06
00813909013367Dental Putty Cartridge 2 x 0.5ccND3620ND36202025-04-25
00813909013374Dental Putty Cartridge 6 x 0.5ccND3660ND36602025-04-25
00813909013473PerioGlas - 2 x 0.5ccND0220ND02202025-04-25
00813909013480PerioGlas 6 x 0.5ccND0260ND02602025-04-25
00813909013503Dental Putty - 6 x 0.5ccND0660ND06602025-04-25
00813909013510Dental Putty Cartridge 4 x 0.25ccND4640ND46402025-04-25
00813909013985Putty Syringe with Cannula 2.5ccNB6502NB65022026-01-28
00813909013992Putty Syringe with Cannula 5.0ccNB6505NB65052026-01-28
00813909014005Putty Syringe with Cannula 10.0ccNB6510NB65102026-01-28
00813909013961Putty Syringe 2.5ccNB2702CTNB2702CT2026-01-09
00813909013978Putty Syringe 5.0ccNB2705CTNB2705CT2026-01-09

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