Identity
- Trade Name
- ROOT CANAL SEALER FDA UDI
- Generic Name
- Endodontic filling/sealing material FDA UDI
- Device Name
- Liquid, 7.5 mL FDA UDI
- Model / Reference
- RSL FDA UDI
- Description
- Liquid, 7.5 mL FDA UDI
Identifiers
- Primary DI / UDI-DI
- D701RSL2 FDA UDI
- 510(k) Number
- K946138 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
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 — 7.5 Milliliter FDA UDI
Category: Endodontic filling/sealing material
Root Canal Sealer by Pulpdent Corporation — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Endodontic filling/sealing material.
- ACROSEAL TUBE — SEPTODONT SAS SPECIALITES SEPTODONT · Class II
- 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
Cleared under the same submission
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
- Pulpdent Corporation
Sources (1)
- FDA UDI 6353cc3b-37ce-45b3-88f5-ebb13861988b 35 fields · synced Jun 9, 2026