FDA.reportPublic FDA data

DX-Condenser

Primary DI
08800017900223
Brand
DX-Condenser
Company
DXM CO., LTD
Model
Set
Device description
Nickel titanium and a stainless-steel end.Can be used in any common obturation technique, including warm and cold condensation. Excellent tactile sense and durability.
Published
2024-07-15
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

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
08800017901800PackageGS13In Commercial Distribution
08800017900223PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08800017901800088000179018008800017901800
08800017900223088000179002238800017900223

GMDN Terms#

Term, Definition table
TermDefinition
Endodontic pluggerA hand-held, manually-operated, dental instrument specifically designed to compress filling materials in a root canal, mainly in an axial direction. The working distal end is cylindrical or tapered, circular in cross-section, and has a flat-tipped end. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
688797315
Device count
1
No natural rubber latex
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08800017902395Fish Bone Bite TraysPosterior Side2026-08-25
08800017902401Fish Bone Bite TraysPosterior Sideless2026-08-25
08800017902418Fish Bone Bite TraysPosterior Half Side2026-08-25
08800017902425Fish Bone Bite TraysQuadrant2026-08-25
08800017902432Fish Bone Bite TraysAnterior2026-08-25
08800017900155DX-Ultra Ultrasonic IrrigationDX-UltraDXU-90002026-08-21
08800017902500DX-Ultra Ultrasonic IrrigationDisposable Plastic TipDXU-90102026-08-21
08800017902524EZ VPS Impression Transfer ConnectorsRibbon Holder2026-08-21
08800017902562EZ VPS Impression Transfer ConnectorsEZ-5100EZ-51002026-08-21
08800017902470FriendoPen TipFE-10042026-07-13
08800017902487Gutta EasyGun Tip 23 GuageGE-1004-23G2026-07-13
08800017902494Gutta EasyGun Tip 25 GuageGE-1004-25G2026-07-13
08800017901640CybirdULTRA2026-04-21
08800017902289EZ BITE BLOCK SOFT MOUTH PROP BBS-5000M2025-12-18
08800017902296EZ BITE BLOCK SOFT MOUTH PROP BBS-6000L2025-12-18
08800017902302EZ BITE BLOCK SOFT MOUTH PROP BBS-5000M2025-12-18
08800017902319EZ BITE BLOCK SOFT MOUTH PROP BBS-6000L2025-12-18
08800017901817EZ Bite blockBB-3000M2025-12-16
08800017900605EZ Bite blockBB-3000M2025-12-16
08800017902203DX-Mixer1802025-09-29

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 TipDENJOY 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