Ultradent Flowable Composite
510(k) K953525
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK953525 | Date28 Aug 1995 | 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- Withdrawn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, 19 Sep 2026
The Ultradent Flowable Composite is a dental restorative material classified as a flowable composite resin (product code EBF). It is designed for use in dental restorations, providing a low-viscosity alternative to traditional composites for easy placement and adaptation to tooth surfaces, particularly in small restorations or as a liner beneath conventional composites.
This device is supplied as a single-use, radiopaque, light-cured material and is intended for use in dental offices. It is not sterile but is packaged in a manner suitable for clinical application. The product is authorized under FDA 510K clearance (K953525) and falls under the Dental advisory committee classification. No additional regulatory status beyond the stated authorization is implied.
Other devices from Ultradent Products, Inc.
Questions
AI-generated answers, 19 Sep 2026
What types of dental restorations is the Ultradent Flowable Composite specifically designed for, and how does it differ from traditional composites?
The Ultradent Flowable Composite is designed for small dental restorations or as a liner beneath conventional composites. Unlike traditional composites, it has a low-viscosity formula, making it easier to place and adapt to tooth surfaces, particularly in tight or intricate areas. This feature helps ensure better flow and adaptation without sacrificing strength or durability.
Is the Ultradent Flowable Composite intended for single-use, and how should it be handled in a clinical setting?
Yes, the Ultradent Flowable Composite is supplied as a single-use material. It is packaged in a way that is suitable for clinical application, though it is not sterile. Clinicians should follow standard dental practice guidelines for handling non-sterile restorative materials, including proper sterilization of instruments and maintaining a clean workspace to minimize contamination risk.
What regulatory pathway was followed for the FDA clearance of the Ultradent Flowable Composite, and what does this mean for its use in dental offices?
The Ultradent Flowable Composite received FDA clearance through a 510(k) Traditional pathway, classified under product code EBF (Dental Restorative Materials) and reviewed by the Dental (DE) Advisory Committee. This means the device was determined to be substantially equivalent to a legally marketed predicate device, allowing it to be legally marketed in the U.S. for its intended dental restorative applications in offices.
How is the Ultradent Flowable Composite cured, and what practical benefits does this offer during dental procedures?
The Ultradent Flowable Composite is light-cured, meaning it hardens when exposed to a dental curing light. This method provides precise control over the curing process, allowing clinicians to shape and adapt the material to the tooth surface before final polymerization. It also reduces the risk of over-curing or under-curing compared to chemically cured alternatives.