N-Hybride-Composite Lc Flow
by VOCO GmbH
510(k) K113444
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK113444 | Date21 Dec 2011 | StatusActive |
Recalls
No FDA recalls found in the data synced 22 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- Withdrawn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, 1 Oct 2026
The N-Hybride Composite LC Flow is a light-cured, flowable nano-hybrid dental restorative composite. It is designed for direct restorations, cavity lining, and luting translucent prosthetics, providing high stability and precise application in dental procedures. Its nano-hybrid composition ensures durability and adhesion to tooth structures, while its flowable nature allows for easy placement in challenging areas.
This device is supplied as a syringe-delivered system for intraoral use in clinical dental settings. It is intended for single-use applications and requires light curing for polymerization. The product is authorized under FDA 510(k) clearance (K113444) and is classified under the product code EBF for dental restorative materials. Storage conditions and sterility are not specified in the provided data.
Other devices from VOCO GmbH
Questions
AI-generated answers, 1 Oct 2026
What is the N-Hybride Composite LC Flow used for in dental procedures?
The N-Hybride Composite LC Flow is designed for direct dental restorations, cavity lining, and luting translucent prosthetics. Its flowable nature allows for easy placement in tight or hard-to-reach areas, while its nano-hybrid composition ensures strong adhesion to tooth structures and long-term durability. This makes it ideal for scenarios requiring both precision and stability.
How is the N-Hybride Composite LC Flow supplied and intended for use?
This composite is supplied as a syringe-delivered system, specifically for intraoral clinical use. The syringe format ensures controlled application, reducing waste and improving handling during procedures. It is intended for single-use only, meaning each syringe should be discarded after one application to maintain sterility and performance.
Does the N-Hybride Composite LC Flow require any special curing process?
Yes, the N-Hybride Composite LC Flow requires light curing for polymerization. This means it must be exposed to a dental curing light to harden properly after placement in the cavity or as a luting agent. Proper curing ensures the material achieves its intended mechanical properties and longevity.
Is the N-Hybride Composite LC Flow reusable or single-use?
The N-Hybride Composite LC Flow is designed for single-use applications only. Using it more than once could compromise sterility, consistency, and performance. The syringe format aligns with single-use standards, ensuring each application starts with a fresh, uncontaminated material.
What regulatory clearance does the N-Hybride Composite LC Flow hold?
The N-Hybride Composite LC Flow holds FDA 510(k) clearance under the reference number K113444. This clearance indicates that the device has been deemed substantially equivalent to a legally marketed predicate device, meeting regulatory standards for safety and effectiveness as a dental restorative material.