CARERITE INTERDENTAL BRUSHES, MODELS 3500 & 4500— 510(k) K870906

Name: FDA 510(k) clearance K870906
Creator: U.S. Food and Drug Administration
Published: 1987-03-30

Substantially Equivalent

Cost Rite Health Products, Inc.

FDA 510(k) clearance K870906 for CARERITE INTERDENTAL BRUSHES, MODELS 3500 & 4500, Substantially Equivalent on 1987-03-30. Applicant: Cost Rite Health Products, Inc.. Device class: 1.

Clearance details

Applicant: Cost Rite Health Products, Inc.
Product code: Code EFW
Device class: Class 1
Regulation: 21 CFR 872.6855
Advisory panel: Dental
Date received: 1987-03-05
Decision date: 1987-03-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Chatsworth, CA, US

Download summary PDF View on FDA.gov ↗

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K891141 — CARERITE FACE MASK1989-04-18
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K873705 — CARERITE FACE MASK1987-10-05
K871798 — FILM AND PAPER COMBINATION STERILIZING BAG1987-07-21
K871736 — CARERITE BIOPACK GINGIVAL RETRACTION CORD1987-05-27

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.