Identity
- Trade Name
- EndoPilot File clamp FDA UDI
- Generic Name
- Endodontic apex locator FDA UDI
- Device Name
- File clamp for EndoPilot FDA UDI
- Model / Reference
- EDP2 FDA UDI
- Description
- File clamp for EndoPilot FDA UDI
Identifiers
- Catalog Number
- 109 2316 FDA UDI
- Primary DI / UDI-DI
- 04260482990916 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
Moist Heat or Steam Sterilization FDA UDI
Category: Endodontic apex locator
EndoPilot File clamp by Schlumbohm GmbH & Co. KG — Class U — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Endodontic apex locator.
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- PATTERSON — PATTERSON DENTAL SUPPLY, INC. · U
- DTE — Guilin Woodpecker Medical Instrument Co., Ltd. · U
- Henry Schein — HENRY SCHEIN, INC. · U
- Brasseler USA — Peter Brasseler Holdings, LLC · U
- OSADA ENDEX PLUS — OSADA ELECTRIC CO., LTD. · U
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 Komet — Schlumbohm GmbH & Co. KG
- EndoPilot Lip-clip — Schlumbohm GmbH & Co. KG
- EndoPilot Motor — Schlumbohm GmbH & Co. KG
- EndoPilot apex cable set — 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 8b81a61a-6ee8-4d6e-8e4d-8ba7b55c843f 35 fields · synced May 31, 2026