TEEN CLEAN, RETAINER CLEANER— 510(k) K860737

Name: FDA 510(k) clearance K860737
Creator: U.S. Food and Drug Administration
Published: 1986-03-26

Substantially Equivalent

Teen Care, Inc.

FDA 510(k) clearance K860737 for TEEN CLEAN, RETAINER CLEANER, Substantially Equivalent on 1986-03-26. Applicant: Teen Care, Inc.. Device class: 1.

Clearance details

Applicant: Teen Care, Inc.
Product code: Code EFT
Device class: Class 1
Regulation: 21 CFR 872.3520
Advisory panel: Dental
Date received: 1986-02-27
Decision date: 1986-03-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: New York, NY, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code EFT

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K080631 — CLEANSE.FRESHEN.GO; ALIGNER CLEANSING TOWELETTE AND DENTAL APPLIANCE CLEANSER2008-05-23
K051342 — MEDICAL INTERPOROUS2006-06-02
K000996 — TRUBYTE DENTURE CLEANSER/POLISHING COMPOUND2000-06-16
K942203 — OTC DENTURE CLEANSER1994-08-10
K930337 — PROFAST(R)-DENTURE CLEANSER1993-09-07

Adverse events under product code EFT

product code EFT

Death: 8
Injury: 267
Total: 275

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.