Identity
- Trade Name
- EdgeLube™ FDA UDI
- Generic Name
- Root canal cleaning solution FDA UDI
- Device Name
- EdgeLube™ (17% EDTA Solution) 0 FDA UDI
- Model / Reference
- 8806387892083 FDA UDI
- Description
- EdgeLube™ (17% EDTA Solution) 0 FDA UDI
Identifiers
- Catalog Number
- 8806387892083 FDA UDI
- Primary DI / UDI-DI
- 00818365021758 FDA UDI
- FDA Product Code
- EKQ FDA UDI
- GMDN Term
- Root canal cleaning solution 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
Yes
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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Root canal cleaning solution
EdgeLube™ by US Endodontics, LLC — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Root canal cleaning solution.
- PS System - Chlor-Xtra Plus Bag (40mL) — Vista Dental · U
- BioPure — TULSA DENTAL PRODUCTS LLC · U
- BioPure — TULSA DENTAL PRODUCTS LLC · U
- Irritrol — ESSENTIAL DENTAL SYSTEMS, INC. · U
- BioPure — TULSA DENTAL PRODUCTS LLC · U
- Avalon Biomed NeoSolv — NUSMILE, LTD · U
- HybenX — BICON, LLC · U
- SmearOFF System (PS System) — Vista Dental · U
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- US Endodontics, LLC
Sources (1)
- FDA UDI 08d2ab0b-7328-4544-8713-e6598988ea52 35 fields · synced Jun 1, 2026