Identity
- Trade Name
- 1.2mL Unit Dose EDTA Kit FDA UDI
- Generic Name
- Root canal cleaning solution FDA UDI
- Model / Reference
- 317002 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 10818207020564 FDA UDI
- FDA Product Code
- KJJ FDA UDI
- GMDN Term
- Root canal cleaning solution FDA UDI
Classification
- Device Class
- U 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
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Root canal cleaning solution
1.2mL Unit Dose EDTA Kit by Vista Dental — Class U — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Root canal cleaning solution.
- 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
- BioPure — TULSA DENTAL PRODUCTS LLC · U
- BioPure — TULSA DENTAL PRODUCTS LLC · 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 U | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Vista Dental
Sources (1)
- FDA UDI e7200ef1-dffc-4b68-ac41-4168b9485664 34 fields · synced May 30, 2026