Tetric EvoFlow Bulk Fill
510(k) K150393
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK150393 | Date9 Jun 2015 | 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- Withdrawn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
- FDA applicant
- Ivoclar Vivadent, AG
- Device class
- Class II
- Regulation
- 21 CFR Part 872.3690
- Advisory committee
- Dental
- FDA decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 18 Sep 2026
Tetric EvoFlow Bulk Fill is a flowable, radiopaque, light-curing composite resin classified as a dental filling material. It is designed for direct restorations in posterior teeth, providing a radiopaque solution that increases in opacity during polymerization, making it suitable for discolored tooth structures.
This material is supplied as a bulk-fill composite, intended for application in increments of up to 4 mm. It is used in Class I and II restorations as an initial layer and is compatible with sculptable composite resins. The device is regulated under an FDA 510(k) clearance (K150393) and is manufactured by Ivoclar Vivadent AG, Schaan, Liechtenstein.
From the manufacturer
Tetric EvoFlow® is the flowable universal composite for restorations in the anterior and posterior region. The material can be used as a liner in Class I and II cavities and as a filling material for small and Class V cavities. It is effectively combined with sculptable composite resins, e.g. Tetric Prime, Tetric PowerFill or IPS Empress® Direct.
Other devices from Ivoclar Vivadent AG
Questions
AI-generated answers, 18 Sep 2026
What types of dental restorations is Tetric EvoFlow Bulk Fill specifically designed for, and why is it considered a bulk-fill composite?
Tetric EvoFlow Bulk Fill is designed for direct restorations in posterior teeth (molars and premolars) as an initial layer in Class I and II cavities. It is classified as a bulk-fill composite because it is formulated to be applied in thicker increments—up to 4 mm—reducing the need for multiple thin layers, which simplifies placement and shortens procedure time while maintaining radiopacity during polymerization.
How does the radiopacity of Tetric EvoFlow Bulk Fill change during use, and what clinical benefit does this provide?
Tetric EvoFlow Bulk Fill increases in radiopacity during polymerization, meaning it becomes more visible on X-rays as it hardens. This is particularly useful for restorations in discolored or translucent tooth structures, as it ensures the filling material remains detectable under radiographic imaging throughout the restoration process, improving diagnostic clarity for clinicians.
Is Tetric EvoFlow Bulk Fill compatible with other composite resins, and how should it be layered in a restoration?
Yes, Tetric EvoFlow Bulk Fill is compatible with sculptable composite resins. It is intended as an initial layer in restorations, applied in increments up to 4 mm, followed by additional layers of sculptable composites for contouring and finishing. This layered approach leverages its bulk-fill properties while allowing for precise shaping of the final restoration.
What regulatory pathway was followed for Tetric EvoFlow Bulk Fill, and what does this mean for its use in clinical practice?
Tetric EvoFlow Bulk Fill was cleared through the FDA’s 510(k) process (K150393) under an abbreviated review (clearance type: Abbreviated) and determined to be substantially equivalent to a predicate device. This means the manufacturer demonstrated that it replicates the performance of an existing, legally marketed device, allowing it to enter the market with the same intended use—direct posterior restorations—while adhering to FDA safety and effectiveness standards.