Signum opaque F— 510(k) K230644

Substantially Equivalent

Kulzer, LLC

FDA 510(k) clearance K230644 for Signum opaque F, Substantially Equivalent on 2023-09-07. Applicant: Kulzer, LLC. Device class: 2.

Clearance details

Applicant: Kulzer, LLC
Product code: Code EBF
Device class: Class 2
Regulation: 21 CFR 872.3690
Advisory panel: Dental
Date received: 2023-03-08
Decision date: 2023-09-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: South Bend, IN, US

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 Kulzer, LLC

K260783 — Venus Diamond; Venus Diamond Flow; Venus Pearl; Venus Bulk Flow One2026-03-11
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K243910 — Retraxil2025-09-24
K240660 — Signum composite flow +6 more2024-09-17
K233868 — dima Print Teeth & Temp2024-05-23

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