DENTAL STERLIZATION TRAY/CASSETTE— 510(k) K983223

Name: FDA 510(k) clearance K983223
Creator: U.S. Food and Drug Administration
Published: 1999-01-14

Substantially Equivalent

Brasseler USA I, L.P.

FDA 510(k) clearance K983223 for DENTAL STERLIZATION TRAY/CASSETTE, Substantially Equivalent on 1999-01-14. Applicant: Brasseler USA I, L.P.. Device class: 2.

Clearance details

Applicant: Brasseler USA I, L.P.
Product code: Code FRG
Device class: Class 2
Regulation: 21 CFR 880.6850
Advisory panel: General Hospital
Date received: 1998-09-14
Decision date: 1999-01-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Atlanta, GA, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code FRG

product code FRG

Other: 3
Total: 3

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.