AccessGUDID - DEVICE: EndoPilot Komet (04260482991029)

GUDID

Device Identifier (DI) Information

Brand Name: EndoPilot Komet
Version or Model: comfort
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 110 0607
Company Name: Schlumbohm GmbH & Co. KG

Primary DI Number: 04260482991029
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 343831731 *Terms of Use

Device Description: EndoPilot² Komet comfort consist of: Control Unit: EndoPilot² unit , Display: 7" TFT touch-screen (Komet) AC/DC Adapter for EndoPilot² Wireless-Footswitch, single, bluetooth Apex-cable-set Retainer for apex-cable Preparation: EndiPilot-Motor with ISO-E standard & LED-indicator, integrated apex-connection EndoPilot-contra-angle, 1:1, insulates, ISO-E standard

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
16355	Endodontic apex locator	A dental instrument, using electricity, designed to locate the top of the root canal during endodontic procedures. This is a reusable device.	Active	false
38347	Dental power tool system handpiece, line-powered	A 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.	Obsolete	false

FDA Product Code

[?]

Product Code	Product Code Name
LQY	Locator, Root Apex
EKX	Handpiece, Direct Drive, Ac-Powered

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K202906	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: Yes

Sterilization Method [?]
Moist Heat or Steam Sterilization
High-level Disinfectant

Storage and Handling

[?]

Storage and Handling
Handling Environment Temperature: between 15 and 40 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 27b30387-d0a4-4ec5-a371-98beaa4c0c71
Public Version Date: June 02, 2021
Public Version Number: 1
DI Record Publish Date: May 25, 2021