STRUCTUR 2 SC— 510(k) K040769

Substantially Equivalent

Voco GmbH

FDA 510(k) clearance K040769 for STRUCTUR 2 SC, Substantially Equivalent on 2004-04-07. Applicant: Voco GmbH. Device class: 2.

Clearance details

Applicant: Voco GmbH
Product code: Code EBG
Device class: Class 2
Regulation: 21 CFR 872.3770
Advisory panel: Dental
Date received: 2004-03-25
Decision date: 2004-04-07
Decision: Substantially Equivalent
Clearance type: Special
Location: Bend, OR, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code EBG

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Recalls naming K040769

K-number listed on FDA's recall record

Z-3015-2026 — Structur 2 SC Temporary Resin Cartridge Refill 75Gm, Product Codes: 1) 114-3933, Mfr Product Code 1479; Lots 2536179, 2606429 2) 114-3934, Mfr Product Code 1480; Lot 2539064 3) 114-3935, Mfr Product Code 1481; Lot 2533123 4) 114-3937, Mfr Product Code 1482; Lots 2533203, 2607170 is a fluorescent cold polymerizing paste-paste system for the production of temporary crowns, bridges, inlays and onlays.Class II·Ongoing·Henry Schein Inc.·20260709

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K040769.

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