FDA.reportPublic FDA data

Dental Cartridge Dispenser

Primary DI
00813909013350
Brand
Dental Cartridge Dispenser
Company
NOVABONE PRODUCTS, LLC
Model
ND3600
Catalog number
ND3600
Device description
Dispenser used with 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
Single use
true

Product Codes#

Code, Name table
CodeName
EIDSyringe, Restorative And Impression Material

Product Code Classifications#

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00813909013350PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00813909013350008139090133508139090133500813909013350

GMDN Terms#

Term, Definition table
TermDefinition
Dental material cartridge-plunging applicator, single-componentA hand-held manual device intended to dispense a single-component dental material (not included) from a cartridge directly into the mouth; it is not intended to dispense more than one component simultaneously. It is typically a pistol-like device with a cartridge-plunging mechanism. This is a reusable device after appropriate cleaning.

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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Primary DI, Brand, Company table
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00197998226755Solventum™ Protemp™Solventum Germany GmbHEID2026-10-08
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
00197998226816Solventum™ Paradigm™Solventum Germany GmbHEID2026-10-08
00197998226823Solventum™ Paradigm™Solventum Germany GmbHEID2026-10-08
00197998226847Solventum™ Garant™Solventum Germany GmbHEID2026-10-08
00810111542951AccessoryBISCO INC.EID2026-10-01
00883205041005Thermo CloneULTRADENT PRODUCTS, INC.EID2026-08-22
08800017902524EZ VPS Impression Transfer ConnectorsDXM CO., LTDEID2026-08-21
08800017902562EZ VPS Impression Transfer ConnectorsDXM CO., LTDEID2026-08-21
07615208353723Mixing TipsIVOCLAR VIVADENT AKTIENGESELLSCHAFTEID2026-08-19
00840456200940JMUJMU DENTAL, INCEID2026-07-20
00840456216743JMUJMU DENTAL, INCEID2026-07-20
00840456218198JMUJMU DENTAL, INCEID2026-07-20
00840456218204JMUJMU DENTAL, INCEID2026-07-20
07615208474398Clinical Auxiliary (no MD)IVOCLAR VIVADENT AKTIENGESELLSCHAFTEID2026-07-14
08809518346721Disposable TipMEDICLUS CO.,LTDEID2026-06-05
10304040194789Henry ScheinHENRY SCHEIN, INC.EID2026-01-20
10304040194796Henry ScheinHENRY SCHEIN, INC.EID2026-01-20
10304040194802Henry ScheinHENRY SCHEIN, INC.EID2026-01-20
10371347019886Advance Dental ProductsThe Atlanta Dental Supply CompanyEID2025-12-30
10371347017783Advance Dental ProductsThe Atlanta Dental Supply CompanyEID2025-11-18
08800017902203DX-MixerDXM CO., LTDEID2025-09-29
08056000372298Dynamic-static Mixing TipsZHERMACK SPAEID2025-03-28
08056000372304Mixing TipsZHERMACK SPAEID2025-03-28