CAMOUFLAGE NANOHYBRID COMPOSITE (UNIVERSAL & FLOWABLE)— 510(k) K133850

Name: FDA 510(k) clearance K133850
Creator: U.S. Food and Drug Administration
Published: 2014-06-04

Substantially Equivalent

Prismatik Dentalcraft, Inc.

FDA 510(k) clearance K133850 for CAMOUFLAGE NANOHYBRID COMPOSITE (UNIVERSAL & FLOWABLE), Substantially Equivalent on 2014-06-04. Applicant: Prismatik Dentalcraft, Inc.. Device class: 2.

Clearance details

Applicant: Prismatik Dentalcraft, Inc.
Product code: Code EBF
Device class: Class 2
Regulation: 21 CFR 872.3690
Advisory panel: Dental
Date received: 2013-12-19
Decision date: 2014-06-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Irvine, CA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code EBF

view all

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 Prismatik Dentalcraft, Inc.

view all

K261802 — Glidewell Denture Base Resin2026-08-27
K262239 — Obsidian® Press Over Zirconia2026-07-30
K254283 — BruxZir® Shaded 16 PLUS2026-01-30
K252582 — Inclusive® Titanium Abutments compatible with: Camlog® CONELOG® Implant System, Dentium® NR Line Implant Systems2025-11-18
K252446 — BruxZir® NOW2025-09-03

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