BRILLIANT COMPONEER— 510(k) K191385

Substantially Equivalent

Coltene/Whaledent AG

FDA 510(k) clearance K191385 for BRILLIANT COMPONEER, Substantially Equivalent on 2019-10-29. Applicant: Coltene/Whaledent AG. Device class: 2.

Clearance details

Applicant: Coltene/Whaledent AG
Product code: Code EBF
Device class: Class 2
Regulation: 21 CFR 872.3690
Advisory panel: Dental
Date received: 2019-05-23
Decision date: 2019-10-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Altstatten, CH

Download summary PDF View on FDA.gov ↗

Recent devices under product code EBF

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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 Coltene/Whaledent AG

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K181500 — BRILLIANT Crios2018-08-15
K160800 — DuoCem2016-11-16
K152927 — BRILLIANT EVERGLOW2016-04-28
K152243 — One Coat 7 Universal2015-12-09

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