Identifiers
- 510(k) Number
- K200175 FDA 510(k)
- FDA Product Code
- KIF FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 872.3820 FDA 510(k)
- Regulation Number
- 872.3820 FDA 510(k)
- Advisory Committee
- Dental FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Dia-Root Bio Sealer is a Resin, Root Canal Filling device, classified as a Class II medical device under FDA regulation 872.3820. It is a pre-mixed bioceramic calcium silicate-based material designed for root canal obturation, providing a non-shrinking seal with strong bonding properties to gutta-percha. Its formulation ensures biocompatibility and radiopacity, making it suitable for permanent root canal sealing.
Supplied as a single-use, pre-mixed material, the Dia-Root Bio Sealer is intended for use in dental settings during endodontic procedures. It is not sterile at the point of sale and must be sterilized prior to use, adhering to standard dental sterilization protocols. The device is authorized under FDA 510K clearance and the European Medical Device Directive (MDD). No MRI safety information is specified, and sizes or additional packaging details are not provided in the data.
Frequently asked questions
What is the Dia-Root Bio Sealer used for in dental procedures?
The Dia-Root Bio Sealer is specifically designed for root canal obturation, which means it fills and seals the root canals of teeth during endodontic treatment. Its bioceramic calcium silicate-based formula provides a non-shrinking seal that bonds strongly to gutta-percha, ensuring a durable and biocompatible closure.
Is the Dia-Root Bio Sealer pre-mixed or does it require mixing before use?
The Dia-Root Bio Sealer is supplied as a pre-mixed material, eliminating the need for on-site preparation. This ensures consistency in formulation and simplifies the clinical workflow during root canal procedures.
How should the Dia-Root Bio Sealer be prepared for clinical use?
The Dia-Root Bio Sealer is not sterile at the point of sale and must be sterilized prior to use following standard dental sterilization protocols. This ensures safety and compliance with infection control measures in the dental setting.
Is the Dia-Root Bio Sealer intended for single-use or can it be reused?
The Dia-Root Bio Sealer is explicitly labeled as a single-use device. After use, it should not be reused to maintain sterility and performance integrity, adhering to best practices for endodontic materials.
What regulatory pathways has the Dia-Root Bio Sealer undergone?
The Dia-Root Bio Sealer has received FDA 510(k) clearance and complies with the European Medical Device Directive (MDD). It is classified as a Class II medical device under FDA regulation 872.3820, indicating it has undergone substantial equivalence review by the FDA’s Dental Advisory Committee.
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. Sources consulted: Dia-Root Bio Sealer - DiaDent, Dia-Root Bio Sealer - Diadent Europe, DiaDent Group International, DIA-ROOT BIO SEALER - Newaydental
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 | K200175 | Class II | Active |
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Manufacturer
- Manufacturer
- Diadent Group International
Sources (2)
- FDA 510(k) K200175 24 fields · synced Sep 18, 2026
- EUDAMED 1 fields · synced Jun 18, 2026