Cleared Traditional

Venus Diamond; Venus Diamond Flow; Venus Pearl; Venus Bulk Flow One

K260783 · Kulzer, LLC · Dental
Mar 2026
Decision
1d
Days
Class 2
Risk

About This 510(k) Submission

K260783 is an FDA 510(k) clearance for the Venus Diamond; Venus Diamond Flow; Venus Pearl; Venus Bulk Flow One, a Material, Tooth Shade, Resin (Class II — Special Controls, product code EBF), submitted by Kulzer, LLC (South Bend, US). The FDA issued a Cleared decision on March 11, 2026, 1 days after receiving the submission on March 10, 2026. This device falls under the Dental review panel. Regulated under 21 CFR 872.3690.

Submission Details

510(k) Number K260783 FDA.gov
FDA Decision Cleared SESE
Date Received March 10, 2026
Decision Date March 11, 2026
Days to Decision 1 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF

Device Classification

Product Code EBF — Material, Tooth Shade, Resin
Device Class Class II — Special Controls
CFR Regulation 21 CFR 872.3690

Similar Devices — EBF Material, Tooth Shade, Resin

All 922
ZAFIRA?
K254245 · New Stetic, SA · Mar 2026
LumiCera
K260170 · Hangzhou SHINING3D Dental Technology Co., Ltd. · Jan 2026
Any-Core
K252465 · Mediclus Co., Ltd. · Dec 2025
MultiMatch Flow Chameleon AntiMicrobial Composite
K253513 · Premier Dental Products Company · Nov 2025
G-BLOCK
K253236 · Graphenano Dental S.L. · Sep 2025
Dura-Crown (CB21-A1/CB21-A2/CB21-A3/CB21-B1)
K253053 · Hangzhou SHINING3D Dental Technology Co., Ltd. · Sep 2025