Identity
- Trade Name
- EndoPilot retainer for apexcable FDA UDI
- Generic Name
- Dental power tool system handpiece, line-powered FDA UDI
- Device Name
- EndoPilot retainer for apexcable FDA UDI
- Model / Reference
- EDP2 FDA UDI
- Description
- EndoPilot retainer for apexcable FDA UDI
Identifiers
- Catalog Number
- 110 2303 FDA UDI
- Primary DI / UDI-DI
- 04260482990817 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
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Dental power tool system handpiece, line-powered
EndoPilot retainer for apexcable 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.
- SMARTmatic PROPHY S19 — KaVo Dental GmbH · Class I
- EXPERTmatic E15 C — KaVo Dental GmbH · Class I
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- Delfin2 — Intra-Lock International · Class I
- MEDIDENTA — HANDPIECE PARTS & REPAIRS, INC. · Class I
- 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 Motor — Schlumbohm GmbH & Co. KG
- EndoPilot apex cable set — 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 ecf77da9-1658-4bf7-a31f-c4342f0d56d0 35 fields · synced May 31, 2026