FILTEK BULK FILL FLOWABLE RESTORATIVE— 510(k) K120453

Name: FDA 510(k) clearance K120453
Creator: U.S. Food and Drug Administration
Published: 2012-03-19

Substantially Equivalent

3M Espe Dental Products

FDA 510(k) clearance K120453 for FILTEK BULK FILL FLOWABLE RESTORATIVE, Substantially Equivalent on 2012-03-19. Applicant: 3M Espe Dental Products. Device class: 2.

Clearance details

Applicant: 3M Espe Dental Products
Product code: Code EBF
Device class: Class 2
Regulation: 21 CFR 872.3690
Advisory panel: Dental
Date received: 2012-02-14
Decision date: 2012-03-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: St. Paul, MN, 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 3M Espe Dental Products

view all

K231338 — 3M Clinpro Clear 2.1% Sodium Fluoride Treatment2023-05-10
K230270 — 3M VitCal Liner/Base2023-02-06
K191122 — 3M RelyX Pediatric Resin Modified Glass Ionomer Cement2019-05-29
K183476 — 3M Filtek Universal Restorative2019-01-02
K141081 — FILTEK BULK FILL POSTERIOR RESTROATIVE2014-05-08

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