Dytract Flow Restorative
510(k) K982395
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK982395 | Date18 Aug 1998 | 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- Withdrawn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, 26 Sep 2026
DYTRACT FLOW RESTORATIVE is a one-component, low-viscosity, visible light-cured dental composite material. It is radiopaque and fluoride-releasing, designed for use in dental restorative procedures.
It is used by dentists in clinical settings for Class I, III, and V restorations, cavity lining, and repair of dental defects or temporaries. The device is supplied as a material for direct application to tooth structure or restoration site and is classified under product code EBF with FDA 510(k) clearance K982395.
Other devices from Dentsply Intl.
Questions
AI-generated answers, 26 Sep 2026
What is DYTRACT FLOW RESTORATIVE used for?
DYTRACT FLOW RESTORATIVE is used by dentists in clinical settings for Class I, III, and V restorations, cavity lining, and repair of dental defects or temporaries. It is designed for direct application to tooth structure or restoration sites as a restorative material.
How is DYTRACT FLOW RESTORATIVE supplied and applied?
DYTRACT FLOW RESTORATIVE is supplied as a one-component, low-viscosity material for direct application to tooth structure or restoration sites. It is a visible light-cured composite that requires curing with a dental curing light after placement.
Is DYTRACT FLOW RESTORATIVE radiopaque and does it release fluoride?
Yes, DYTRACT FLOW RESTORATIVE is radiopaque, which allows it to be visible on dental radiographs, and it is fluoride-releasing, providing ongoing fluoride release to help prevent secondary caries around the restoration.