BEAM BRUSH/BEAM APP— 510(k) K121165

Name: FDA 510(k) clearance K121165
Creator: U.S. Food and Drug Administration
Published: 2012-06-21

Substantially Equivalent

Beam Technologies, LLC

FDA 510(k) clearance K121165 for BEAM BRUSH/BEAM APP, Substantially Equivalent on 2012-06-21. Applicant: Beam Technologies, LLC. Device class: 1.

Clearance details

Applicant: Beam Technologies, LLC
Product code: Code EFW
Device class: Class 1
Regulation: 21 CFR 872.6855
Advisory panel: Dental
Date received: 2012-04-17
Decision date: 2012-06-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Louisville, KY, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code EFW

view all

K130186 — DENTEK EASY BRUSH WITH FLUORIDE2013-07-15
K102871 — SILVER CARE ANITBACTERIAL TOOTHBRUSH2011-10-03
K073224 — ORAL-B SUB-BRAND MANUAL TOOTHBRUSH2008-02-06
K021383 — ZEODYNE TOOTHBRUSH WITH AGION ANTIMICROBIAL2002-07-17
K020776 — MEDORAL HYGIENIC TOOTHBRUSH WITH DENTOSAN FILAMENTS2002-06-03

Adverse events under product code EFW

product code EFW

Injury: 143
Malfunction: 698
Total: 841

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

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