FDA.reportPublic FDA data

Gutta Easy

Primary DI
08800017900063
Brand
Gutta Easy
Company
DXM CO., LTD
Model
Gutta Easy
Device description
The Gutta Easy is the highly efficient gutta percha back fill obturation device.With its distinctive and inimitable features, the Gutta Easy makes thermo-plasticized root canal obturation much easier and faster than ever. The Gutta Easy's powerful and rapid heating control mechanisms delivers reliable and optimum clinical results.
Published
2023-06-19
Public version status
New
Distribution status
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
08800017900063PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08800017900063088000179000638800017900063

GMDN Terms#

Term, Definition table
TermDefinition
Root canal obturation kitA collection of sterile dental devices, synthetic materials, and solutions designed to permanently prime, seal, and fill a tooth undergoing a root canal procedure. This device typically includes materials such as a primer (for bonding to the walls of the canal), a sealer (for bonding to the primer), and endodontic points and pellets (for the filling). This bonding process creates a monoblock filling resulting in increased resistance to bacteria penetration and fracture for root canal-treated teeth. This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Atmospheric Pressure60 KiloPascal106 KiloPascal
Handling Environment Humidity10 Percent (%) Relative Humidity85 Percent (%) Relative Humidity
Handling Environment Temperature10 Degrees Celsius40 Degrees Celsius

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
688797315
Device count
1
Serial number
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
08800017900223DX-CondenserSet2024-07-15
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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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