FDA UDI
In Commercial Distribution
🇺🇸 United States
EndoPilot Komet
DI: 04260482991029
·
Model: comfort
·
Schlumbohm GmbH & Co. KG
Product Codes
2
GMDN Terms
2
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- EndoPilot Komet
- Primary DI
- 04260482991029
- Version / Model
- comfort
- Catalog Number
- 110 0607
- Company Name
- Schlumbohm GmbH & Co. KG
- Labeler DUNS
- 343831731
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2021-05-25
- Public Version
- 1
- Public Version Date
- 2021-06-02
- Public Version Status
- New
- Public Device Record Key
- 27b30387-d0a4-4ec5-a371-98beaa4c0c71
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
- Single Use
- No
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- Yes
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- Yes
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- Yes
- Sterilization Methods
- ["Moist Heat or Steam Sterilization", "High-level Disinfectant"]
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| LQY | Locator, Root Apex | Unknown | U | |
| EKX | Handpiece, Direct Drive, Ac-Powered | Dental | 872.4200 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 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. | No | Active |
| 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. | No | Obsolete |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 04260482991029 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K202906 | 000 |
Storage Conditions
- Type
- Handling Environment Temperature
- Temperature Range
- 15 – 40 Degrees Celsius