Infinix Universal Composite, Infinix Flowable Composite, Infinix Bulk Fill Flow Composite— 510(k) K201010

Name: FDA 510(k) clearance K201010
Creator: U.S. Food and Drug Administration
Published: 2020-08-14

Substantially Equivalent

Nobio , Ltd.

FDA 510(k) clearance K201010 for Infinix Universal Composite, Infinix Flowable Composite, Infinix Bulk Fill Flow Composite, Substantially Equivalent on 2020-08-14. Applicant: Nobio , Ltd.. Device class: 2.

Clearance details

Applicant: Nobio , Ltd.
Product code: Code EBF
Device class: Class 2
Regulation: 21 CFR 872.3690
Advisory panel: Dental
Date received: 2020-04-17
Decision date: 2020-08-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Kadima, IL

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 Nobio , Ltd.

view all

K183391 — Novidia Universal Bond2019-09-24
K182921 — Infinix Universal Composite2019-09-13
K182714 — Novidia Bulk Fill Flow Composite2019-07-12
K182580 — Novidia Flowable Composite2019-07-03

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