Identity
- Trade Name
- EndoPilot D-Pack² handpiece FDA UDI
- Generic Name
- Endodontic obturation system FDA UDI
- Device Name
- Obturation handpiece D-Pack² for EndoPilot FDA UDI
- Model / Reference
- v04 FDA UDI
- Description
- Obturation handpiece D-Pack² for EndoPilot FDA UDI
Identifiers
- Catalog Number
- 109 0151-04 FDA UDI
- Primary DI / UDI-DI
- 04260482991166 FDA UDI
- 510(k) Number
- K202906 FDA UDI
- FDA Product Code
- EKR FDA UDI
- GMDN Term
- Endodontic obturation system FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 872.4565 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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
High-level Disinfectant FDA UDI
Category: Endodontic obturation system
EndoPilot D-Pack² handpiece by Schlumbohm GmbH & Co. KG — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Endodontic obturation system.
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- DUO-PEN — DiaDent Group International · Class I
- B&L-Beta(W) — B&L Biotech Co., Ltd. · Class I
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 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 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 I | Pending data |
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Manufacturer
- Manufacturer
- Schlumbohm GmbH & Co. KG
Sources (1)
- FDA UDI f7d2efbc-99d3-4cfb-ace5-f0052aaa3861 35 fields · synced May 30, 2026