Medi Galaxy Flow, Medi Classic, Medi Pearl, Medi Jupiter, Medi Opaque Posterior, Medi White Pearl
510(k) K170873
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK170873 | Date2 Oct 2017 | 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- Withdrawn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 device is a visible light-cure, radiopaque composite restorative material composed of multifunctional methacrylate monomer-based resin, photo initiators, silanated inorganic fillers, and pigments. It is designed for use in anterior and posterior dental restorations.
It is packaged in syringes or pre-loaded tips and used by dental professionals. The device has received FDA 510(k) clearance under product code EBF and is supplied as a sterile, single-use restorative material for dental applications.
Questions
AI-generated answers, 19 Sep 2026
What types of dental restorations can the Medi Galaxy Flow, Medi Classic, and related products be used for, and how does their visible light-cure feature work?
The Medi Galaxy Flow, Medi Classic, Medi Pearl, Medi Jupiter, Medi Opaque Posterior, and Medi White Pearl are designed specifically for anterior and posterior dental restorations. These materials are visible light-cured, meaning they harden when exposed to a dental curing light, allowing precise application by dental professionals. The resin-based composition ensures durability and aesthetic blending with natural teeth, while the radiopaque fillers make them visible on X-rays for better monitoring.
Are these restorative materials single-use, and if so, how should they be stored to maintain sterility?
Yes, the Medi Galaxy Flow and related products are sterile, single-use materials, meaning each syringe or pre-loaded tip is intended for one patient application only. To preserve sterility, they should be stored in a cool, dry place, away from direct sunlight and extreme temperatures. Unopened packaging should remain intact until use, and any unused portions should be discarded after opening to prevent contamination.
What packaging options are available for these restorative materials, and how does that affect their clinical use?
The Medi Galaxy Flow and related products are supplied in syringes or pre-loaded tips, which allow for precise dispensing during dental procedures. The syringe format is ideal for clinicians who prefer controlled material flow, while pre-loaded tips offer convenience for quick application. Both formats ensure ease of use in both anterior (front teeth) and posterior (back teeth) restorations, with the radiopaque properties ensuring visibility under X-ray for follow-up evaluations.
What distinguishes the different product variants (e.g., Medi Galaxy Flow vs. Medi Opaque Posterior) in terms of intended use?
While all variants share the same core composition—visible light-cure, radiopaque composite resin—they differ primarily in pigmentation and opacity to suit specific clinical needs. For example, the Medi Opaque Posterior is likely designed for posterior restorations where higher opacity may be beneficial, while Medi White Pearl or Medi Pearl may offer a more natural, translucent finish for anterior teeth. The Medi Galaxy Flow suggests a flowable consistency, ideal for layering or filling undercuts, whereas others may be more rigid for structural restorations.