REACH ANTIBACTERIAL TOOTHBRUSH— 510(k) K971589

Name: FDA 510(k) clearance K971589
Creator: U.S. Food and Drug Administration
Published: 1997-07-24

Substantially Equivalent

Personal Products Co.

FDA 510(k) clearance K971589 for REACH ANTIBACTERIAL TOOTHBRUSH, Substantially Equivalent on 1997-07-24. Applicant: Personal Products Co.. Device class: 1.

Clearance details

Applicant: Personal Products Co.
Product code: Code EFW
Device class: Class 1
Regulation: 21 CFR 872.6855
Advisory panel: Dental
Date received: 1997-05-01
Decision date: 1997-07-24
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Skillman, NJ, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code EFW

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

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K062796 — K-Y BRAND INTRIGUE2006-12-08
K010365 — ORTHO CONTROL FEMALE URINARY CONTROL DEVICE2001-04-30
K990536 — O.B. TAMPON1999-08-31
K991118 — O.B. APPLICATOR TAMPONS, O.B. TAMPONS1999-06-29

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.