DeviceClearance

ULTRASONIC SCALER, MODELS VARIOS 350 LUX, VARIOS 350 (NO LIGHT), VARIOS 550, VARIOS 150 LUX, VARIOS 150 (NO LIGHT)— 510(k) K031421

Substantially Equivalent

Nakanishi, Inc.

FDA 510(k) clearance K031421 for ULTRASONIC SCALER, MODELS VARIOS 350 LUX, VARIOS 350 (NO LIGHT), VARIOS 550, VARIOS 150 LUX, VARIOS 150 (NO LIGHT), Substantially Equivalent on 2004-03-26. Applicant: Nakanishi, Inc.. Device class: 2.

Clearance details

Applicant
Nakanishi, Inc.
Product code
Code ELC
Device class
Class 2
Regulation
21 CFR 872.4850
Advisory panel
Dental
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Schaumburg, IL, US
Download summary PDFView on FDA.gov ↗

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Adverse events under product code ELC

product code ELC
Malfunction
1,255
Total
1,255

Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Recalls naming K031421

K-number listed on FDA's recall record

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K031421.

Data sourced from openFDA. This site is unofficial and independent of the FDA.