FDA.reportPublic FDA data

EndoPilot Obtura set

Primary DI
04260482991128
Brand
EndoPilot Obtura set
Company
Schlumbohm GmbH & Co. KG
Model
v01
Catalog number
110 0133-US
Device description
EndoPilot Obtura expansion set consist of:1x BackFill Gun Obtura, 1x Obtura Needle Lock Nut, 4x Heat Insulator, 5x Gun-Needle Ø 25 ga, 100x Gutta Percha Bar, Accessory tools
Published
2021-10-14
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
EKMGutta-Percha
EKRPlugger, Root Canal, Endodontic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EKMGutta-PerchaDental1
EKRPlugger, Root Canal, EndodonticDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04260482991128PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04260482991128042604829911284260482991128

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"", ""High-level Disinfectant""]"
Moist Heat or Steam Sterilization;High-level Disinfectant

Regulatory Flags#

DUNS number
343831731
Device count
1
Serial number
true
Manufacturing date on label
true
Expiration date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04260482991227CanalPro Jeni Setv07600429282026-05-20
04260482991166EndoPilot D-Pack² handpiecev04109 0151-042025-01-28
04260482991173EndoPilot² expansion DownPack²v01110 0132-US-v012025-01-28
04260482990824Extension set ultrasonic for EndoPilotv01110 30022022-08-26
04260482990190EndoPilot D-Packv03109 01512021-09-10
04260482991135EndoPilot DownPack expansion setv00110 0132-US2021-09-10
04260482990084EndoPilot MotorEDP2109 01122021-06-02
04260482990602EndoPIlot wireless-footswitch, singlebluetooth109 23612021-06-02
04260482990763EndoPilot Control Box, KometEDP2110 20112021-06-02
04260482990787EndoPilot power supplyUS110 22032021-06-02
04260482990817EndoPilot retainer for apexcableEDP2110 23032021-06-02
04260482990923EndoPilot Cap for lip-contactEDP2109 23182021-06-02
04260482990282EndoPilot apex cable setEDP2109 23112021-05-31
04260482990305EndoPilot Lip-clipEDP2109 23142021-05-31
04260482990589EndoPilot Apex measuring cable with plugEDP2109 23122021-05-31
04260482990596EndoPilot wireless-footswitch, twinbluetooth109 23512021-05-31
04260482990893EndoPilot cable for file clampEDP2109 23152021-05-31
04260482990916EndoPilot File clampEDP2109 23162021-05-31
04260482990091EndoPilot contra-angle1:1109 01262021-05-25
04260482991029EndoPilot Kometcomfort110 06072021-05-25

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
06979865810120JAS Gutta-Percha PelletsDENJOY DENTAL CO.,LTDEKM2026-09-24
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
J0030525020Z1Gutta Percha Points ISOMAILLEFER INSTRUMENTS HOLDING SàrlEKM2026-08-26
J0030525025Z1Gutta Percha Points ISOMAILLEFER INSTRUMENTS HOLDING SàrlEKM2026-08-26
J0030525030Z1Gutta Percha Points ISOMAILLEFER INSTRUMENTS HOLDING SàrlEKM2026-08-26
J0030525035Z1Gutta Percha pointsMAILLEFER INSTRUMENTS HOLDING SàrlEKM2026-08-26
J0030525040Z1Gutta Percha pointsMAILLEFER INSTRUMENTS HOLDING SàrlEKM2026-08-26
J0030525045Z1Gutta Percha pointsMAILLEFER INSTRUMENTS HOLDING SàrlEKM2026-08-26
J0030525050Z1Gutta Percha pointsMAILLEFER INSTRUMENTS HOLDING SàrlEKM2026-08-26
J0030525055Z1Gutta Percha pointsMAILLEFER INSTRUMENTS HOLDING SàrlEKM2026-08-26
J0030525060Z1Gutta Percha pointsMAILLEFER INSTRUMENTS HOLDING SàrlEKM2026-08-26
J0030525160Z1Gutta Percha pointsMAILLEFER INSTRUMENTS HOLDING SàrlEKM2026-08-26
J0030525165Z1Gutta Percha Points GPMAILLEFER INSTRUMENTS HOLDING SàrlEKM2026-08-26
J0030530F1Gutta Percha Points GPMAILLEFER INSTRUMENTS HOLDING SàrlEKM2026-08-26
J0030530FF1Gutta Percha Points GPMAILLEFER INSTRUMENTS HOLDING SàrlEKM2026-08-26
J0030530FFZ1Gutta Percha Points GPMAILLEFER INSTRUMENTS HOLDING SàrlEKM2026-08-26
J0030530FM1Gutta Percha Points GPMAILLEFER INSTRUMENTS HOLDING SàrlEKM2026-08-26
J0030530FMZ1Gutta Percha Points GPMAILLEFER INSTRUMENTS HOLDING SàrlEKM2026-08-26
J0030530FZ1Gutta Percha Points GPMAILLEFER INSTRUMENTS HOLDING SàrlEKM2026-08-26