Identity
- Trade Name
- Sodium Hypochlorite Solution FDA UDI
- Generic Name
- Root canal cleaning solution FDA UDI
- Device Name
- Sodium Hypochlorite Solution 16 oz. FDA UDI
- Model / Reference
- 0011507FG FDA UDI
- Description
- Sodium Hypochlorite Solution 16 oz. FDA UDI
Identifiers
- Catalog Number
- 0011507FG FDA UDI
- Primary DI / UDI-DI
- D6870011507FG2 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
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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Dimensions & Sizes
- Size
- Total Volume — 473 Milliliter FDA UDI
Category: Root canal cleaning solution
Sodium Hypochlorite Solution by Dentsply International — Class U — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Root canal cleaning solution.
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- 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 U | Pending data |
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Manufacturer
- Manufacturer
- Dentsply International
Sources (1)
- FDA UDI 77b20b0f-c693-42fe-9575-7a94eb2cd175 37 fields · synced May 30, 2026