DeviceClearance

ASC-12 PIEZOELECTRIC SCALER— 510(k) K070866

Substantially Equivalent

Aseptico, Inc.

FDA 510(k) clearance K070866 for ASC-12 PIEZOELECTRIC SCALER, Substantially Equivalent on 2007-04-11. Applicant: Aseptico, Inc.. Device class: 2.

Clearance details

Applicant
Aseptico, 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
Woodinville, WA, 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 →

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