FDA.reportPublic FDA data

Dental Mini Cartridge Dispenser

Primary DI
00813909010762
Brand
Dental Mini Cartridge Dispenser
Company
NOVABONE PRODUCTS, LLC
Model
NA4600
Catalog number
NA4600
Device description
Dispenser used with Synthetic bone void filler for dental applications
Published
2016-03-07
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Product Codes#

Code, Name table
CodeName
EIDSyringe, Restorative And Impression Material
LYCBone Grafting Material, Synthetic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EIDSyringe, Restorative And Impression MaterialDental1
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
00813909010762PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00813909010762008139090107628139090107620813909010762

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

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
828813290
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Sterilization required before use
true

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

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00197998226762Solventum™ Protemp™Solventum Germany GmbHEID2026-10-08
00197998226779Solventum™ Protemp™Solventum Germany GmbHEID2026-10-08
00197998226786Solventum™ Protemp™Solventum Germany GmbHEID2026-10-08
00197998226809Solventum™ Paradigm™Solventum Germany GmbHEID2026-10-08
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00197998226823Solventum™ Paradigm™Solventum Germany GmbHEID2026-10-08
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