Fusion Core DC Flo; Fusion Flo; Fusion Flo SE; Fusion 1 Seal; Magna NT— 510(k) K231263
Substantially EquivalentPrevest Denpro Limited
FDA 510(k) clearance K231263 for Fusion Core DC Flo; Fusion Flo; Fusion Flo SE; Fusion 1 Seal; Magna NT, Substantially Equivalent on 2024-01-05. Applicant: Prevest Denpro Limited. Device class: 2.
Clearance details
- Applicant
- Prevest Denpro Limited
- Product code
- Code EBF
- Device class
- Class 2
- Regulation
- 21 CFR 872.3690
- Advisory panel
- Dental
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Bari Brahmana, IN
Recent devices under product code EBF
view allMore clearances from Prevest Denpro Limited
view all- K233273 — C&B Ceramic; C&B Permanent; C&B Interim
- K231696 — Fusion Bond 5, Fusion Bond 7, Fusion Bond DC, Renew MDP, Renew Universal
- K213244 — Accusil Dental Impression Materials (Accusil Light Body Regular and Fast Set, Accusil Heavy Body Regular and Fast Set, Accusil Monophase Regular and Fast Set, Accusil Putty Regular and Fast Set, Accusil Bite Registration)
- K212563 — CalApex Calplus, Cerafill RCS, Endoseal, Nanoseal S, Zical Ultra Paste, Zical Ultra Powder/Liquid
- K212475 — Prevest Denpro Cavity Liners (Apacal ART, Cal LC, Calcigel, CalUltra)
Data sourced from openFDA. This site is unofficial and independent of the FDA.