3M Dent II System
FDA 510(k)Class II (US FDA 510(k))
by 3m Company
Identifiers
- 510(k) Number
- K981647 FDA 510(k)
- FDA Product Code
- EBF FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 872.3690 FDA 510(k)
- Regulation Number
- 872.3690 FDA 510(k)
- Advisory Committee
- Dental FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The 3M Dent II System is a visible-light-activated, radiopaque restorative material classified as a dental resin composite (product code EBF). It is designed for direct and indirect dental restorations, utilizing a monomer chemistry based on TEGDMA and BISGMA to provide durable and aesthetically integrated tooth repairs. This material is intended for use in clinical dental settings where precise shade matching and structural integrity are required.
Supplied as a single-use system, the 3M Dent II System is intended for use in sterile dental procedures. It is regulated under FDA 510(k) clearance (K981647) and falls under Class II – Special Controls for dental materials. The product is manufactured by 3M Company and must be stored according to manufacturer guidelines to maintain efficacy and sterility. No additional regulatory markings beyond the FDA clearance are specified.
Frequently asked questions
What is the 3M Dent II System used for in dental procedures?
The 3M Dent II System is a radiopaque dental resin composite designed for both direct and indirect restorations. Its monomer chemistry—based on TEGDMA and BISGMA—ensures durability and seamless integration with natural tooth structure. It’s ideal for clinical settings requiring precise shade matching and long-lasting repairs, such as fillings or crown preparations.
How is the 3M Dent II System supplied, and is it sterile?
The system is supplied as a single-use package, ensuring sterility for clinical procedures. This design eliminates cross-contamination risks and aligns with sterile dental practice standards. Each kit is intended for one-time use only, maintaining both safety and regulatory compliance.
Is the 3M Dent II System reusable, or is it meant for single applications?
The 3M Dent II System is explicitly designed for single-use only. This approach guarantees sterility and consistency in performance, as reuse could compromise material integrity or introduce contamination. The manufacturer’s guidelines emphasize one-time clinical application to uphold efficacy and safety.
What storage conditions are required to preserve the system’s sterility and performance?
The system must be stored according to the manufacturer’s instructions to retain sterility and functionality. This typically includes protection from moisture, extreme temperatures, and direct light. Unopened kits should be kept in their original packaging until use, as exposure to environmental factors could degrade the resin composite’s properties or compromise sterility.
Does the 3M Dent II System require any special regulatory approvals beyond FDA 510(k) clearance?
The system holds FDA 510(k) clearance (K981647) under Class II – Special Controls for dental materials, confirming its compliance with U.S. regulatory standards. No additional regulatory markings beyond this clearance are specified in the product documentation, though adherence to manufacturer guidelines remains critical for safe use.
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: K981647 - 3M DENT II SYSTEM | FDA 510 (k) | 3M Company, 3m Dent Ii System 510 (k) FDA Premarket Notification K981647 3M COMPANY, 3M DENT II SYSTEM (K981647) — FDA 510 (k) | Innolitics, 3M DENT SYSTEM II PLUS (K973961) — FDA 510 (k) | Innolitics
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K981647 | Class II | Active |
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Manufacturer
- Manufacturer
- 3m Company
Sources (1)
- FDA 510(k) K981647 24 fields · synced Oct 1, 2026