Identifiers
- 510(k) Number
- K982729 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 Renew LS-2 is a dental resin material used for tooth shade restoration, classified under product code EBF. It is designed to provide durable and aesthetically pleasing dental restorations, aligning with the intended function of resin-based filling materials in restorative dentistry.
This device is supplied as a single-use system and is intended for use in dental offices. It is regulated under FDA 510(k) clearance (K982729) and falls under the Dental advisory committee classification. The material is intended for professional application by trained dental practitioners and must be stored according to manufacturer guidelines to maintain sterility and performance.
Frequently asked questions
What is the Renew LS-2 dental resin material primarily used for in clinical practice?
The Renew LS-2 is specifically designed for tooth shade restoration in restorative dentistry, providing durable and aesthetically pleasing fillings. It is intended for professional application by trained dental practitioners to match natural tooth color and structure.
Is the Renew LS-2 system single-use or reusable, and how should it be stored?
The Renew LS-2 is supplied as a single-use system, meaning each package is intended for one-time use only. To maintain sterility and performance, it must be stored according to the manufacturer’s guidelines, which likely include protection from contamination and environmental factors.
What regulatory pathway does the Renew LS-2 follow, and which committee oversees its classification?
The Renew LS-2 follows the FDA 510(k) clearance pathway, classified under product code EBF (Dental Resin Materials). It was reviewed by the Dental (DE) Advisory Committee and granted a 'Substantially Equivalent' determination under a traditional 510(k) process.
Who is the manufacturer of the Renew LS-2, and where can I contact them for additional information?
The manufacturer of the Renew LS-2 is Bisco, Inc., located at 1100 W. Irving Park Rd., Schaumburg, IL 60193. For inquiries, you may contact Kathy Jung, though the exact contact method isn’t specified in the data.
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: K003361 - RENEW LS-2 | FDA 510 (k) | Bisco, Inc.
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K982729 | Class II | Active |
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Manufacturer
- Manufacturer
- Bisco Inc.
- FDA Applicant
- Bisco, Inc.
Sources (1)
- FDA 510(k) K982729 24 fields · synced Sep 19, 2026