FDA.reportPublic FDA data

E&Q Master / Gun needle set [23G]

Primary DI
08806387890331
Brand
E&Q Master / Gun needle set [23G]
Company
Meta Biomed Co., Ltd.
Model
9033
Device description
Warmed Gutta Percha Obturation System
Published
2022-09-24
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
EKRPlugger, Root Canal, Endodontic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EKRPlugger, Root Canal, EndodonticDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08806387890331PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08806387890331088063878903318806387890331

GMDN Terms#

Term, Definition table
TermDefinition
Endodontic obturation systemAn assembly of devices intended to be used during endodontic treatment involving root canal obturation procedures. It may be used in a variety of modes, e.g., to provide continuous heat to the tip of a dental instrument to test tooth response to thermal stimulus, for tissue cauterization and coagulation, and to backfill and down pack gutta-percha during endodontic root canal treatment or root canal obturation. It typically consists of a mains electricity (AC-powered) generator that regulates an electrical current used to produce resistive heat via the handpieces for the application of the heat, or extrude gutta-percha during a root canal obturation.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
688322841
Device count
1
Premarket exempt
true
Serial number
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08806387895190BeneMedik, 1~2mm, 30cc95192016-09-19
08806387895275BeneMedik, 4~6mm, 1cc95272016-09-19
08806387897002BoneMedik-DM, 0.1~0.3mm, 0.25g97002016-09-19
08806387897019BoneMedik-DM, 0.1~0.3mm, 0.5g97012016-09-19
08806387897026BoneMedik-DM, 0.1~0.3mm, 1.0g97022016-09-19
08806387897033Bonemedik-DM, 0.1~0.3mm, 2g97032016-09-19
08806387897040BoneMedik-DM, 0.1~0.3mm, 5g97042016-09-19
08806387897057BoneMedik-DM, 0.1~0.3mm, 10g97052016-09-19
08806387897064BoneMedik-DM 0.3~0.5mm, 0.25g97062016-09-19
08806387897071BoneMedik-DM, 0.3~0.5mm, 0.5g97072016-09-19
08806387897088BoneMedik-DM 0.3~0.5mm, 1.0g97082016-09-19
08806387897095BoneMedik-DM 0.3~0.5mm, 2.0g97092016-09-19
08806387897101BoneMedik-DM, 0.3~0.5mm, 5g97102016-09-19
08806387897118BoneMedik-DM, 0.3~0.5mm, 10g97112016-09-19
08806387897125BoneMedik-DM 0.5~1.0mm, 0.25g97122016-09-19
08806387897132BoneMedik-DM 0.5~1.0mm, 0.5g97132016-09-19
08806387897149BoneMedik-DM 0.5~1.0mm, 1.0g97142016-09-19
08806387897156BoneMedik-DM 0.5~1.0mm, 2.0g97152016-09-19
08806387897163BoneMedik-DM, 0.5~1mm, 5g97162016-09-19
08806387897170BoneMedik-DM, 0.5~1mm, 10g97172016-09-19

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06979865810038JAS MotorDENJOY DENTAL CO.,LTDEKR2026-09-24
06979865810045JAS FillDENJOY DENTAL CO.,LTDEKR2026-09-24
06979865810052JAS PexDENJOY DENTAL CO.,LTDEKR2026-09-24
06979865810069JAS ActivatorDENJOY DENTAL CO.,LTDEKR2026-09-24
06979865810076JAS Charging UnitDENJOY DENTAL CO.,LTDEKR2026-09-24
06979865810083JAS Contra-AngleDENJOY DENTAL CO.,LTDEKR2026-09-24
06979865810090JAS Power SupplyDENJOY DENTAL CO.,LTDEKR2026-09-24
06979865810106JAS Activator Ultrasonic TipsDENJOY DENTAL CO.,LTDEKR2026-09-24
06979865810113JAS Fill Gutta-Percha NeedlesDENJOY DENTAL CO.,LTDEKR2026-09-24
06979865810137JAS Heat Plugger TipsDENJOY DENTAL CO.,LTDEKR2026-09-24
06979865810168JAS Pack Gutta-Percha CutterDENJOY DENTAL CO.,LTDEKR2026-09-24
06979865810175JAS Unit Endo SystemDENJOY DENTAL CO.,LTDEKR2026-09-24
G8791062850DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEKR2026-08-08
G8791062880DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEKR2026-08-08
08404535018981Brasseler USAPeter Brasseler Holdings, LLCEKR2026-06-26
00348783009002Premier PluggersPREMIER DENTAL PRODUCTS COMPANYEKR2026-04-30
00348783009019Premier PluggersPREMIER DENTAL PRODUCTS COMPANYEKR2026-04-30
00348783009026Premier PluggersPREMIER DENTAL PRODUCTS COMPANYEKR2026-04-30
00348783009033Premier PluggersPREMIER DENTAL PRODUCTS COMPANYEKR2026-04-30
00348783009057Premier PluggersPREMIER DENTAL PRODUCTS COMPANYEKR2026-04-30
00348783008975Premier PluggersPREMIER DENTAL PRODUCTS COMPANYEKR2026-04-29
00348783008982Premier PluggersPREMIER DENTAL PRODUCTS COMPANYEKR2026-04-29
00348783008999Premier PluggersPREMIER DENTAL PRODUCTS COMPANYEKR2026-04-29
00348783009125Premier PluggersPREMIER DENTAL PRODUCTS COMPANYEKR2026-04-29
00348783009132Premier PluggersPREMIER DENTAL PRODUCTS COMPANYEKR2026-04-29
00348783009149Premier PluggersPREMIER DENTAL PRODUCTS COMPANYEKR2026-04-29
00348783008913Premier PluggersPREMIER DENTAL PRODUCTS COMPANYEKR2026-04-28
00348783008920Premier PluggersPREMIER DENTAL PRODUCTS COMPANYEKR2026-04-28
00348783008937Premier PluggersPREMIER DENTAL PRODUCTS COMPANYEKR2026-04-28
00348783008944Premier PluggersPREMIER DENTAL PRODUCTS COMPANYEKR2026-04-28