FDA.reportPublic FDA data

EndoPilot Control Box, Komet

Primary DI
04260482990763
Brand
EndoPilot Control Box, Komet
Company
Schlumbohm GmbH & Co. KG
Model
EDP2
Catalog number
110 2011
Device description
EndoPilot² Control Box, Komet
Published
2021-06-02
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
EKXHandpiece, Direct Drive, Ac-Powered
LQYLocator, Root Apex

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EKXHandpiece, Direct Drive, Ac-PoweredDental1
LQYLocator, Root ApexUnknownU

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K202906000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K202906000EndoPilot2Schlumbohm GmbH & Co. KG2021-04-13ELC

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04260482990763PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04260482990763042604829907634260482990763

GMDN Terms#

Term, Definition table
TermDefinition
Dental power tool system handpiece, line-poweredA hand-held, mains electricity (AC-powered) dental device that includes a chuck or collet for attaching a dental endpiece (e.g., drill bit, bur, reamer, saw blade, polishing disk) intended to be used in dentistry to bore/excavate bones, teeth, and tough tissues. It is powered by a low-voltage electric micro-motor (e.g., 24 volt) that is an integral part of the device; the endpiece(s) are not included. It is typically connected through the dental delivery system or a freestanding independent control unit. This is a reusable device.

Sterilization Methods#

Method table
Method
High-level Disinfectant

Regulatory Flags#

DUNS number
343831731
Device count
1
Serial number
true
Manufacturing 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
04260482991128EndoPilot Obtura setv01110 0133-US2021-10-14
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
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
D1001309252002Apex File Grip (Set of 2)FORUM ENGINEERING TECHNOLOGIES (96) LTD.LQY2026-05-27
D1001309253002Apex Lip hook (Set of 2)FORUM ENGINEERING TECHNOLOGIES (96) LTD.LQY2026-05-27
10817417020227AsepticoASEPTICO, INC.EKX2026-04-08
10817417020326AsepticoASEPTICO, INC.EKX2026-04-08
10817417020371AsepticoASEPTICO, INC.EKX2026-04-06
10817417020388AsepticoASEPTICO, INC.EKX2026-04-06
10817417020418AsepticoASEPTICO, INC.EKX2026-04-03
10817417020425AsepticoASEPTICO, INC.EKX2026-04-03
10817417020432AsepticoASEPTICO, INC.EKX2026-04-03
10817417020449AsepticoASEPTICO, INC.EKX2026-04-03
08033837938316CEFLACEFLA SOCIETA' COOPERATIVALQY2026-03-31
08809260475458E-CUBESaeshin Precision Co., Ltd.EKX2026-03-31
10194665008444A-decA-DEC, INC.LQY2026-02-19
10194665008475A-decA-DEC, INC.EKX2026-02-19
10194665008475A-decA-DEC, INC.LQY2026-02-19
10194665008482A-decA-DEC, INC.EKX2026-02-19
10194665008482A-decA-DEC, INC.LQY2026-02-19
10194665008499A-decA-DEC, INC.LQY2026-02-19
10194665008499A-decA-DEC, INC.EKX2026-02-19
10194665008505A-decA-DEC, INC.EKX2026-02-19
10194665008505A-decA-DEC, INC.LQY2026-02-19
10194665008512A-decA-DEC, INC.EKX2026-02-19
10194665008512A-decA-DEC, INC.LQY2026-02-19
10194665008529A-decA-DEC, INC.LQY2026-02-19
10194665008529A-decA-DEC, INC.EKX2026-02-19
10194665008550A-decA-DEC, INC.LQY2026-02-19
10194665008550A-decA-DEC, INC.EKX2026-02-19
09010522002513SmartPeg Type 127Osstell ABEKX2026-02-09
09010522002537SmartPeg Type 137Osstell ABEKX2026-02-09
D100B00XSGO000000X-Smart Go Cordless endo motor with integrated apex locatorFORUM ENGINEERING TECHNOLOGIES (96) LTD.EKX2026-01-23