Identity
- Trade Name
- BioRoot RCS Liquid Refill Kit FDA UDI
- Generic Name
- Endodontic filling/sealing material FDA UDI
- Device Name
- Mixing Solution single dose container (20x 0.20mL) FDA UDI
- Model / Reference
- 01E0310 FDA UDI
- Description
- Mixing Solution single dose container (20x 0.20mL) FDA UDI
Identifiers
- Primary DI / UDI-DI
- 03760140704516 FDA UDI
- FDA Product Code
- KIF FDA UDI
- GMDN Term
- Endodontic filling/sealing material FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 872.3820 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
Yes
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: Endodontic filling/sealing material
BioRoot RCS Liquid Refill Kit by Septodont Sas Specialites Septodont — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Endodontic filling/sealing material.
- Pulp Canal Sealer — Ormco Corporation · Class II
- ROEKO GuttaFlow®2 — Coltène/Whaledent AG · Class I
- Midway Select — MIDWAY DENTAL SUPPLY, LLC · Class I
- Henry Schein — HENRY SCHEIN, INC. · Class II
- GIBSON — BENCO DENTAL SUPPLY CO. · Class II
- Midway Select — MIDWAY DENTAL SUPPLY, LLC · Class I
- DIA-ROOT BIO Sealer — DiaDent Group International · Class II
- Henry Schein — HENRY SCHEIN, INC. · Class II
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 II | Pending data |
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Manufacturer
- Manufacturer
- Septodont Sas Specialites Septodont
Sources (1)
- FDA UDI 30603082-0653-444a-a7b0-2429b0b3bcf5 34 fields · synced May 30, 2026