DiaPaste Resin Root Canal Filling
FDA 510(k)FDA UDIEUDAMEDClass II (US FDA 510(k))
Identity
- Trade Name
- DIAPASTE EUDAMEDFDA UDI
- Generic Name
- Endodontic filling/sealing material FDA UDI
- Device Name
- DiaPaste EUDAMEDDiapaste is a calcium hydroxide paste with barium sulfate, used as a temporary root canal filling material. FDA UDI
- Model / Reference
- DiaPaste Type A EUDAMEDA1001-401 EUDAMEDDiaPaste Type C EUDAMEDA1001-403 EUDAMEDDiaPaste Intro Kit EUDAMEDA1001-405 EUDAMEDIntro Kit FDA UDIType A FDA UDIType C 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
- A1001-405 FDA UDIA1001-401 FDA UDIA1001-403 FDA UDI
- Primary DI / UDI-DI
- 08806383564670 EUDAMEDFDA UDI08806383564632 EUDAMEDFDA UDI08806383564656 EUDAMEDFDA UDI
- Basic UDI-DI
- B-08806383564632 EUDAMEDB-08806383564656 EUDAMEDB-08806383564670 EUDAMED
- FDA Product Code
- KIF FDA 510(k)FDA UDI
- EMDN Code
- Q01010201 ROOT CANAL FILLING DENTAL PASTES EUDAMED
- GMDN Term
- Endodontic filling/sealing material FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA 510(k)FDA UDI
- Legislation / Framework
- 21 CFR Part 872.3820 FDA 510(k)
- Regulation Number
- 872.3820 FDA 510(k)FDA UDI
- Market of Registration
- Netherlands EUDAMED
- Advisory Committee
- Dental FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
No
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
Yes
Manufacturing Date
No
The DiaPaste Resin Root Canal Filling is a dental material classified as a Resin, Root Canal Filling under FDA nomenclature. It is designed for use in endodontic procedures to seal the root canal system, providing a biocompatible and radiopaque filling material to restore treated teeth.
This device is supplied as a single-use, non-sterile paste intended for professional dental use. It is regulated under FDA 510(k) clearance (K210333) and the EU Medical Device Directive (MDD), with a classification of Class II. Storage follows standard dental practice guidelines, and its application requires adherence to established endodontic techniques.
Frequently asked questions
Is DiaPaste intended for use in any specific dental procedures beyond root canal filling?
DiaPaste is specifically designed for endodontic procedures to seal the root canal system during root canal treatments. It is not indicated for general dental restorations or other procedures outside of root canal filling, as described in its classification as a 'Resin, Root Canal Filling' under FDA nomenclature.
How should DiaPaste be stored, and what are the implications of its non-sterile status?
DiaPaste is supplied as a non-sterile paste, meaning it must be sterilized by the dental professional using standard dental sterilization techniques before use. Storage follows general dental practice guidelines, ensuring it remains uncontaminated until sterilization. This requires adherence to established protocols to maintain its integrity and safety for endodontic procedures.
Are there multiple sizes or models of DiaPaste available, and how would I identify them?
DiaPaste is supplied as a single-use paste, but it comes in multiple registration numbers (e.g., 3002807757, 3003120666, etc.) which may correspond to different product variants or batches. These registration numbers are tied to its regulatory filings and do not necessarily indicate distinct sizes or models. For precise identification, refer to the packaging or consult the manufacturer, DiaDent Group International, as these numbers are used for tracking and compliance purposes.
What regulatory pathways has DiaPaste followed for approval, and what does this mean for clinicians?
DiaPaste has received FDA clearance under the 510(k) pathway (K210333) and complies with the EU Medical Device Directive (MDD). The FDA clearance indicates it is deemed 'substantially equivalent' to a predicate device, meaning it meets established safety and effectiveness standards for root canal filling materials. Clinicians can rely on this clearance as evidence of its regulatory review for intended use in endodontic procedures.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them.
Authorization Coverage (2 countries)
Regulatory Authorizations
MDD
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDD | — | Class II | Active |
| FDA 510(k) | United States | FDA_510K | K210333 | Class II | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Diadent Group International
Sources (7)
- FDA 510(k) K210333 24 fields · synced Sep 18, 2026
- FDA UDI c041b100-dac3-4e88-b1c2-f84c8317c900 36 fields · synced May 30, 2026
- FDA UDI 0d60ab14-c770-4f4c-84f0-dafba6a8a50a 36 fields · synced May 30, 2026
- FDA UDI b632f52f-39d6-489d-8c06-709511f81a4b 36 fields · synced May 30, 2026
- EUDAMED e743faf7-4128-416c-a8d1-ed634ebea37d 61 fields · synced Jul 13, 2026
- EUDAMED b7315a26-da9c-47b7-94cd-ff3e83d16ea2 61 fields · synced Jul 16, 2026
- EUDAMED c3583037-41e2-43f2-b0bd-d7502a0fc5dd 61 fields · synced Jul 18, 2026