Identity
- Trade Name
- EDTA FDA UDI
- Generic Name
- Dental tooth-cleaning solution FDA UDI
- Device Name
- EdgeEndo EDTA is an EDTA solution in water with surfactant to lower surface tension. The solution is a root canal cleanser for use in endotontic procedures to remove the smear layer. FDA UDI
- Model / Reference
- EEEDTA FDA UDI
- Description
- EdgeEndo EDTA is an EDTA solution in water with surfactant to lower surface tension. The solution is a root canal cleanser for use in endotontic procedures to remove the smear layer. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00818365020058 FDA UDI
- FDA Product Code
- KJJ FDA UDI
- GMDN Term
- Dental tooth-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
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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Dimensions & Sizes
- Size
- Total Volume — 480 Milliliter FDA UDI
Category: Dental tooth-cleaning solution
Edta by Edge Endo Llc — Class U — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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 |
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Manufacturer
- Manufacturer
- Edge Endo Llc
Sources (1)
- FDA UDI 68647e55-5fe3-4058-8783-2060d46b957c 34 fields · synced Jun 6, 2026