FDA.reportPublic FDA data

Dental Cartridge Dispenser

Primary DI
00813909010724
Brand
Dental Cartridge Dispenser
Company
NOVABONE PRODUCTS, LLC
Model
NA3600
Catalog number
NA3600
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
00813909010724PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00813909010724008139090107248139090107240813909010724

GMDN Terms#

Term, Definition table
TermDefinition
Dental material injection cannula, reusableA rigid or semi-rigid luminal device (dental tip) intended to channel and dispense a dental material/solution [e.g., restorative amalgam, resin, etching solution (etchant), topical dental anaesthetic] from a dental syringe, or similar applicator, to a patient’s teeth, oral mucosa, or gums; it is not intended to penetrate tissue (it is not a needle), not dedicated to root canal irrigation, and may be used for dental applications outside the patients mouth. This is a reusable device.

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
00813909013589Wound MatrixWM0122SPWM0122SP2026-02-17
00813909013596Wound MatrixWM0123SPWM0123SP2026-02-17
00813909013602Wound MatrixWM0133SPWM0133SP2026-02-17
00813909013619Wound MatrixWM0145SPWM0145SP2026-02-17
00813909013657Wound MatrixWM1011SPWM1011SP2026-02-17
00813909013664Wound MatrixWM1022SPWM1022SP2026-02-17
00813909013671Wound MatrixWM1044SPWM1044SP2026-02-17
00813909013695Wound MatrixWM1033SPWM1033SP2026-02-17
00813909012827Wound MatrixWM0122WM01222023-12-01
00813909012834Wound MatrixWM0123WM01232023-12-01
00813909012841Wound MatrixWM0133WM01332023-12-01
00813909012858Wound MatrixWM0145WM01452023-12-01
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
00813909013909Putty 2.5ccNB0602NVNB0602NV2025-12-26
00813909013916Putty 5.0ccNB0605NVNB0605NV2025-12-26
00813909013923Porous Morsels 1-2mm 5.0ccNB1805NVNB1805NV2025-12-26

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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08056000372328Mixing TipsZHERMACK SPAEID2025-03-28
08800017901923DX-MixerDXM CO., LTDEID2024-06-04
08800017901978DX-MixerDXM CO., LTDEID2024-06-04
08800017902005DX-MixerDXM CO., LTDEID2024-06-04
08800017902029DX-MixerDXM CO., LTDEID2024-06-04
07640164360041Gibson Healthcare AlloplastDegradable Solutions AGLYC2024-03-05
07640164360065Gibson Healthcare AlloplastDegradable Solutions AGLYC2024-03-05
07615208353730Clinical Accessory (no MD)IVOCLAR VIVADENT AKTIENGESELLSCHAFTEID2023-10-25
08800017901893Dynamic MixerDXM CO., LTDEID2023-10-25
08800017901879Dynamic MixerDXM CO., LTDEID2023-10-24
08800017901848DX-MixerDXM CO., LTDEID2023-07-31
08800017901657DX-MixerDXM CO., LTDEID2023-07-26
00020221017809EXEL 1mL CARRYING AND DELIVERY SYRINGEExel InternationalEID2023-04-21
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07615208379297CannulaIVOCLAR VIVADENT AKTIENGESELLSCHAFTEID2023-03-23
08800040686200Osstem Mixing TipOsstem Implant Co.,Ltd.EID2022-12-08
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08800040686224Osstem Mixing TipOsstem Implant Co.,Ltd.EID2022-12-08
08800040686231Osstem Mixing TipOsstem Implant Co.,Ltd.EID2022-12-08
08800121767071Osstem Mixing TipOsstem Implant Co.,Ltd.EID2022-12-08
H66809218671BosworthKeystone IndustriesEID2022-11-30
00842092155844ImplantlinkPreat CorporationEID2022-10-25
EZHIC2020850Mixing TipsZHERMACK SPAEID2022-06-15
EZHIC2020700Mixing TipsZHERMACK SPAEID2022-06-14
EZHIC2020800Mixing TipsZHERMACK SPAEID2022-06-14