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
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
08800017902265DX-Mixer1802025-09-29
08800017901930C-WarmerDual2024-07-15
08800017902043Disposable Impression Bite TraySide/Posterior[BT-1000]2024-06-11
08800017902074Disposable Impression Bite TraySideless[BT-2000]2024-06-11
08800017902050Disposable Impression Bite TraySide/Posterior[BT-1000]2024-06-11
08800017902067Disposable Impression Bite TraySideless[BT-2000]2024-06-11
08800017902098Disposable Impression Bite TrayQuadrant[BT-3000]2024-06-11
08800017901923DX-Mixer1302024-06-04
08800017901978DX-Mixer1202024-06-04
08800017902005DX-Mixer1502024-06-04
08800017902029DX-Mixer2102024-06-04
08800017900292DX-Mixer1302024-06-04

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
00348783008951Premier PluggersPREMIER DENTAL PRODUCTS COMPANYEKR2026-04-28
00348783009088Premier PluggersPREMIER DENTAL PRODUCTS COMPANYEKR2026-04-28
00348783009095Premier PluggersPREMIER DENTAL PRODUCTS COMPANYEKR2026-04-28
00348783009101Premier PluggersPREMIER DENTAL PRODUCTS COMPANYEKR2026-04-28
00348783009118Premier PluggersPREMIER DENTAL PRODUCTS COMPANYEKR2026-04-28
E89616970207E0SCHWERTA. Schweickhardt GmbH & Co. KGEKR2025-10-14
E89616970307E0SCHWERTA. Schweickhardt GmbH & Co. KGEKR2025-10-14
E89616970TI07E0SCHWERTA. Schweickhardt GmbH & Co. KGEKR2025-10-14
E896169701TI07E0SCHWERTA. Schweickhardt GmbH & Co. KGEKR2025-07-16
E8961697020TI0SCHWERTA. Schweickhardt GmbH & Co. KGEKR2025-06-24
00813677024480PDT, Inc.PDT, INC.EKR2024-06-27
00813677024985PDT, Inc.PDT, INC.EKR2024-06-27
00843471100288Obtura SpartanYoung Innovations, Inc.EKR2024-01-15
00843471100301Obtura SpartanYoung Innovations, Inc.EKR2024-01-15
00843471100431Obtura SpartanYoung Innovations, Inc.EKR2024-01-15