DREAM CLEANSE S SCALER, DREAM COMPACT S SCALER— 510(k) K033044

Name: FDA 510(k) clearance K033044
Creator: U.S. Food and Drug Administration
Published: 2004-12-21

Substantially Equivalent

American Green Dent. Mfg, Inc.

FDA 510(k) clearance K033044 for DREAM CLEANSE S SCALER, DREAM COMPACT S SCALER, Substantially Equivalent on 2004-12-21. Applicant: American Green Dent. Mfg, Inc.. Device class: 2.

Clearance details

Applicant: American Green Dent. Mfg, Inc.
Product code: Code ELC
Device class: Class 2
Regulation: 21 CFR 872.4850
Advisory panel: Dental
Date received: 2003-09-29
Decision date: 2004-12-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Los Angeles, CA, US

Download summary PDF View on FDA.gov ↗

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K033045 — DREAM BOND, DREAMCAST CHROME, DREAMCAST V, DREAM FLEXICAST, DREAM LITHECAST2003-12-23

Adverse events under product code ELC

product code ELC

Malfunction: 1,255
Total: 1,255

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.