Identity
- Trade Name
- EndoPilot Motor FDA UDI
- Generic Name
- Dental power tool system handpiece, line-powered FDA UDI
- Device Name
- EndoPilot Motor with ISO-E standard; LED-indicator and Apex-contact FDA UDI
- Model / Reference
- EDP2 FDA UDI
- Description
- EndoPilot Motor with ISO-E standard; LED-indicator and Apex-contact FDA UDI
Identifiers
- Catalog Number
- 109 0112 FDA UDI
- Primary DI / UDI-DI
- 04260482990084 FDA UDI
- 510(k) Number
- K202906 FDA UDI
- FDA Product Code
- EKX FDA UDI
- GMDN Term
- Dental power tool system handpiece, line-powered FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 872.4200 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: Dental power tool system handpiece, line-powered
EndoPilot Motor by Schlumbohm GmbH & Co. KG — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Dental power tool system handpiece, line-powered.
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- SM3 — Osstem Implant Co., Ltd._Gasan Branch · Class II
- Delfin — Intra-Lock International · Class I
- EXPERTmatic E15 L — KaVo Dental GmbH · 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 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 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 2e965434-ab51-49c3-9b2b-b55eb2f22ef8 35 fields · synced Jun 1, 2026