Renamel Sculpt
510(k) K993658
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK993658 | Date18 Jan 2000 | StatusActive |
Recalls
No FDA recalls found in the data synced 26 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA Product Code
- EBF
- Device Class
- Class II
- Regulation
- 21 CFR Part 872.3690
- Advisory Committee
- Dental
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 20 Sep 2026
The Renamel Sculpt is a light-cured composite restorative material system classified under the Dental Restorative Device category (Product Code: EBF). It is designed for dental professionals to perform Class II and Class V restorations, as well as lingual wall build-ups in Class IV anterior restorations. This material is engineered to provide durable and aesthetically pleasing dental repairs, adhering to the structural and functional requirements of restorative dentistry.
Renamel Sculpt is supplied as a dental restorative system and is intended for single-use applications in clinical settings. The device is cleared under FDA 510(k) with a Substantially Equivalent determination (K993658) and follows the Traditional 510(k) review pathway. It is not specified as MRI-safe, sterile, or reusable, and no additional storage or handling instructions are provided beyond standard dental composite protocols. The product is regulated as a Class II device under the FDA’s dental classification system.
Other devices from Cosmedent, Inc.
Questions
AI-generated answers, 20 Sep 2026
What types of dental restorations is the Renamel Sculpt specifically designed for, and how does it differ from general composite materials?
The Renamel Sculpt is engineered for Class II and Class V restorations, as well as lingual wall build-ups in Class IV anterior restorations. Unlike general composite materials, it is formulated to meet the structural and aesthetic demands of these specific repair scenarios, ensuring durability and a natural appearance for functional and cosmetic dental repairs.
Is the Renamel Sculpt intended for reuse in clinical settings, or is it meant for single-use only?
The Renamel Sculpt is explicitly intended for single-use applications in clinical settings. This aligns with standard dental composite protocols, where materials are typically used once per patient to maintain sterility and safety.
How is the Renamel Sculpt regulated by the FDA, and what does the 'Substantially Equivalent' determination mean in this context?
The Renamel Sculpt is regulated as a Class II dental restorative device under FDA’s Product Code EBF and was cleared via a Traditional 510(k) review pathway with a Substantially Equivalent (SESE) determination (K993658). This means the FDA found it to be as safe and effective as a legally marketed predicate device, meeting regulatory standards for dental restorative materials without requiring additional pre-market approval.
Are there any special storage or handling instructions for the Renamel Sculpt beyond standard dental composite protocols?
The provided data does not specify unique storage or handling instructions beyond what is standard for dental composite materials. Clinicians should follow general dental protocols for composite restoratives, such as protecting from contamination, extreme temperatures, and improper lighting, to ensure optimal performance.