Vittra APS Unique Flow— 510(k) K232994

Substantially Equivalent

Dentscare Ltda

FDA 510(k) clearance K232994 for Vittra APS Unique Flow, Substantially Equivalent on 2024-10-18. Applicant: Dentscare Ltda. Device class: 2.

Clearance details

Applicant: Dentscare Ltda
Product code: Code EBF
Device class: Class 2
Regulation: 21 CFR 872.3690
Advisory panel: Dental
Date received: 2023-09-22
Decision date: 2024-10-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Joinville, BR

Download summary PDF View on FDA.gov ↗

Recent devices under product code EBF

K262202 — Cerasmart Forte2026-09-10
K261695 — Flowable Restorative Material (KP-Flow LF, KP-Flow MF, KP-Flow HF)2026-08-31
K261485 — Tetric plus Fill; Tetric plus Flow2026-07-01
K262228 — Transcend Bulk Fill Flowable Composite2026-07-01
K261246 — SRGC-062026-06-18

More clearances from Dentscare Ltda

K231859 — PrimmaArt2024-11-26
K210231 — Vittra APS Unique2021-10-14
K201707 — Opallis, Opallis Flow2020-12-22
K192682 — Orthocem, Ortho Bite2020-08-14
K191389 — Allcem Veneer APS2020-02-25

Data sourced from openFDA. This site is unofficial and independent of the FDA.