Identity
- Trade Name
- DIAPASTE FDA UDI
- Generic Name
- Endodontic filling/sealing material FDA UDI
- Device Name
- Diapaste is a calcium hydroxide paste with barium sulfate, used as a temporary root canal filling material. FDA UDI
- Model / Reference
- Refill Kit FDA UDI
- Description
- Diapaste is a calcium hydroxide paste with barium sulfate, used as a temporary root canal filling material. FDA UDI
Identifiers
- Catalog Number
- A1001-404 FDA UDI
- Primary DI / UDI-DI
- 08806383564663 FDA UDI
- 510(k) Number
- K190091 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
Category: Endodontic filling/sealing material
Diapaste by DiaDent Group International — 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
- Henry Schein — HENRY SCHEIN, INC. · Class II
Cleared under the same submission
K190091 also covers:
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
- DiaDent Group International
Sources (1)
- FDA UDI f299a8d4-51c9-4d3e-aadd-57737e0fa744 36 fields · synced May 30, 2026