LUTE VLC; CORE VLC— 510(k) K011309

Substantially Equivalent

First Scientific Limited

FDA 510(k) clearance K011309 for LUTE VLC; CORE VLC, Substantially Equivalent on 2001-06-22. Applicant: First Scientific Limited. Device class: 2.

Clearance details

Applicant: First Scientific Limited
Product code: Code EBF
Device class: Class 2
Regulation: 21 CFR 872.3690
Advisory panel: Dental
Date received: 2001-04-30
Decision date: 2001-06-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Blaenau Gwent, Wales, GB

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 First Scientific Limited

K011521 — ORTHO VLC; ORTHO VLC CAPSULE2001-08-01
K011520 — RESTORE-X2001-07-23
K011517 — LUTE; CORE2001-07-10
K011295 — RESTORE-PF VIC; RESTORE-PF VLC CAPSULE2001-06-27

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