DeviceClearance

ET III Bio-SA Fixture System— 510(k) K151626

Substantially Equivalent

Hiossen, Inc.

FDA 510(k) clearance K151626 for ET III Bio-SA Fixture System, Substantially Equivalent on 2016-07-21. Applicant: Hiossen, Inc.. Device class: 2.

Clearance details

Applicant
Hiossen, Inc.
Product code
Code DZE
Device class
Class 2
Regulation
21 CFR 872.3640
Advisory panel
Dental
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Fariless Hills, PA, US
Download summary PDFView on FDA.gov ↗

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More clearances from Hiossen, Inc.

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Adverse events under product code DZE

product code DZE
Death
28
Injury
3,367,041
Malfunction
19,958
Other
13
Total
3,387,040

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 K151626

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 K151626.

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