Identity
- Trade Name
- EndoPilot apex cable set FDA UDI
- Generic Name
- Endodontic apex locator FDA UDI
- Device Name
- Apex-cable-Set for Endopilot, consist of: 1x measuring cable with plug; 1x lip clip; 1x cap for lip contact; 1x cable for file clamp; 1x file clamp, dismountable; 1x Bushing for lip-clip cable-socket FDA UDI
- Model / Reference
- EDP2 FDA UDI
- Description
- Apex-cable-Set for Endopilot, consist of: 1x measuring cable with plug; 1x lip clip; 1x cap for lip contact; 1x cable for file clamp; 1x file clamp, dismountable; 1x Bushing for lip-clip cable-socket FDA UDI
Identifiers
- Catalog Number
- 109 2311 FDA UDI
- Primary DI / UDI-DI
- 04260482990282 FDA UDI
- 510(k) Number
- K202906 FDA UDI
- FDA Product Code
- LQY FDA UDI
- GMDN Term
- Endodontic apex locator FDA UDI
Classification
- Device Class
- U FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Endodontic apex locator
EndoPilot apex cable set by Schlumbohm GmbH & Co. KG — Class U — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Endodontic apex locator.
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- DTE — Guilin Woodpecker Medical Instrument Co., Ltd. · U
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Cleared under the same submission
K202906 also covers:
- EndoPIlot wireless-footswitch, single — Schlumbohm GmbH & Co. KG
- EndoPilot Apex measuring cable with plug — Schlumbohm GmbH & Co. KG
- EndoPilot Cap for lip-contact — Schlumbohm GmbH & Co. KG
- EndoPilot Control Box, Komet — Schlumbohm GmbH & Co. KG
- EndoPilot D-Pack — Schlumbohm GmbH & Co. KG
- EndoPilot D-Pack² handpiece — Schlumbohm GmbH & Co. KG
- EndoPilot DownPack expansion set — Schlumbohm GmbH & Co. KG
- EndoPilot File clamp — Schlumbohm GmbH & Co. KG
- EndoPilot Komet — Schlumbohm GmbH & Co. KG
- EndoPilot Lip-clip — Schlumbohm GmbH & Co. KG
- EndoPilot Motor — Schlumbohm GmbH & Co. KG
- EndoPilot cable for file clamp — Schlumbohm GmbH & Co. KG
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class U | Pending data |
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Manufacturer
- Manufacturer
- Schlumbohm GmbH & Co. KG
Sources (1)
- FDA UDI 2384df8d-de39-4857-bba0-0a1df5d95d78 35 fields · synced May 30, 2026