Bulk Fill Flowable Composite
510(k) K141994
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK141994 | Date14 Nov 2014 | 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- Withdrawn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, 20 Sep 2026
The Bulk Fill Flowable Composite is a resin-based dental restorative material classified as a flowable composite under the FDA’s Dental product code (EBF). It is designed for posterior restorations, offering low viscosity to facilitate easy placement in deep cavities with minimal instrumentation. The material incorporates a proprietary blend of monomers and fillers to minimize polymerization shrinkage and stress, enabling bulk-fill techniques up to a depth of cure of 4 mm.
This device is supplied as a single-use dental restorative material and is intended for use in clinical dental settings. It is not sterile at time of shipment but is packaged to maintain sterility until opened. The product is regulated under the FDA’s 510(k) clearance (K141994) as substantially equivalent to predicate devices, adhering to traditional review standards. No additional regulatory markings (e.g., MRI safety, reusable status) are specified in the submission data.