FDA.reportPublic FDA data

MAX-JECT DENTAL NEEDLES

Primary DI
D89260705413552
Brand
MAX-JECT DENTAL NEEDLES
Company
MAXILL, INC.
Model
6070541355
Published
2022-09-06
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
DZMNeedle, Dental

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DZMNeedle, DentalDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
D89260705413552PackageHIBCC5000In Commercial Distribution
D89260705413551PrimaryHIBCC0
D89260705413550Unit of UseHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Dental anaesthesia syringe/needleA hand-held manual dental instrument consisting of a barrel (cylinder) with plunger/piston intended to be used for injecting an anaesthetic agent, subcutaneously or intramuscularly, from a prefilled, single-use cartridge through an included sterile needle; the needle may be attached or detached. The syringe is typically made of plastic and/or silicone materials. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
079343581
Device count
100
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
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
D89260705601802PACKARD HEALTHCARE SELF SEALING STERILIZATION POUCHES60705601802024-01-12
D89260705601812PACKARD HEALTHCARE SELF SEALING STERILIZATION POUCHES60705601812024-01-12
D89260705601822PACKARD HEALTHCARE SELF SEALING STERILIZATION POUCHES60705601822024-01-12
D89260705601832PACKARD HEALTHCARE SELF SEALING STERILIZATION POUCHES60705601832024-01-12
D89260705601842PACKARD HEALTHCARE SELF SEALING STERILIZATION POUCHES60705601842024-01-12
D89260705601852PACKARD HEALTHCARE SELF SEALING STERILIZATION POUCHES60705601852024-01-12
D89260705601862PACKARD HEALTHCARE SELF SEALING STERILIZATION POUCHES60705601862024-01-12
D89260705601872PACKARD HEALTHCARE SELF SEALING STERILIZATION POUCHES60705601872024-01-12
D8926070553277D11maxill Frames Eyewear Adult6070553277D12022-11-15
D89260705532601maxill Frames Eyewear60705532602022-11-14
D89260705532631maxill Frames Eyewear60705532632022-11-14
D8926070553265D21maxill Frames Eyewear Kids6070553265D22022-11-14
D8926070553265D31maxill Frames Eyewear Kids6070553265D32022-11-14
D8926070553275C01maxill Frames Eyewear Adult6070553275C02022-11-14
D8926070553275C11maxill Frames Eyewear Adult6070553275C12022-11-14
D8926070553275C21maxill Frames Eyewear Adult6070553275C22022-11-14
D8926070553275C31maxill Frames Eyewear Adult6070553275C32022-11-14
D8926070553275C91maxill Frames Eyewear Adult6070553275C92022-11-14
D8926070553276C01maxill Frames Eyewear Adult6070553276C02022-11-14
D8926070553276C11maxill Frames Eyewear Adult6070553276C12022-11-14

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810126508218Essentials By 3D Dental3D DENTAL DESIGNS AND DEVELOPMENT, LLCDZM2026-03-11
00810126508225Essentials By 3D Dental3D DENTAL DESIGNS AND DEVELOPMENT, LLCDZM2026-03-11
50192253037430MonojectCardinal Health 200, LLCDZM2026-02-10
50192253037454MonojectCardinal Health 200, LLCDZM2026-02-10
50192253037461MonojectCardinal Health 200, LLCDZM2026-02-10
50192253037478MonojectCardinal Health 200, LLCDZM2026-02-10
50192253037492MonojectCardinal Health 200, LLCDZM2026-02-10
50192253037515MonojectCardinal Health 200, LLCDZM2026-02-10
50192253037522MonojectCardinal Health 200, LLCDZM2026-02-10
50192253037539MonojectCardinal Health 200, LLCDZM2026-02-10
00840456213629JMUJMU DENTAL, INCDZM2025-12-22
00840456213636JMUJMU DENTAL, INCDZM2025-12-22
00840456213643JMUJMU DENTAL, INCDZM2025-12-22
00840456213650JMUJMU DENTAL, INCDZM2025-12-22
00841336101029Salvin Dental SpecialtiesSALVIN DENTAL SPECIALTIES, LLCDZM2025-11-11
00842517112360Karl SchumacherKarl Schumacher Dental, LLCDZM2025-07-08
00842517112384Karl SchumacherKarl Schumacher Dental, LLCDZM2025-07-08
00842517112421Karl SchumacherKarl Schumacher Dental, LLCDZM2025-07-08
00842517112476Karl SchumacherKarl Schumacher Dental, LLCDZM2025-07-08
00842517112483Karl SchumacherKarl Schumacher Dental, LLCDZM2025-07-08
08800123817903V-JectVERICOM CO., LTD.DZM2025-06-25
08800123817941V-JectVERICOM CO., LTD.DZM2025-06-25
08800123817965V-JectVERICOM CO., LTD.DZM2025-06-25
06936018502202baixinAnhui Kangda Medical Products Co.,Ltd.DZM2025-05-28
06936018502257baixinAnhui Kangda Medical Products Co.,Ltd.DZM2025-05-28
G001HSB1071100House BrandChengdu Xinjin Shifeng Medical Apparatus & Instrument Co., Ltd.DZM2024-09-06
86974456210057CICADAFoshan Cicada Dental Instrument Co., Ltd.DZM2024-08-10
86974456210217CICADAFoshan Cicada Dental Instrument Co., Ltd.DZM2024-08-10
86974456210224CICADAFoshan Cicada Dental Instrument Co., Ltd.DZM2024-08-10
G001HSB1071102House Brand DentistryChengdu Xinjin Shifeng Medical Apparatus & Instrument Co., Ltd.DZM2024-06-05