Identity
- Trade Name
- Endo-Express FDA UDI
- Generic Name
- Dental power tool handpiece motorless component FDA UDI
- Device Name
- Endo-Express E Type 4-Hole Air Motor FDA UDI
- Model / Reference
- 5510-00 FDA UDI
- Description
- Endo-Express E Type 4-Hole Air Motor FDA UDI
Identifiers
- Catalog Number
- 5510-00 FDA UDI
- Primary DI / UDI-DI
- 00766054001201 FDA UDI
- FDA Product Code
- EGS FDA UDI
- GMDN Term
- Dental power tool handpiece motorless component FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 872.4200 FDA UDI
- Commercial Distribution
- Not 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
Yes
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Endo-Express by Essential Dental Systems, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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
- Essential Dental Systems, Inc.
Sources (1)
- FDA UDI afaafb14-7a7c-4330-bc0e-cf6e6fd88837 36 fields · synced Jun 1, 2026