DeviceClearance

BONE BLOCK FIXATION SET— 510(k) K050515

Substantially Equivalent

Straumann USA, Inc.

FDA 510(k) clearance K050515 for BONE BLOCK FIXATION SET, Substantially Equivalent on 2005-04-05. Applicant: Straumann USA, Inc.. Device class: 2.

Clearance details

Applicant
Straumann USA, Inc.
Product code
Code DZL
Device class
Class 2
Regulation
21 CFR 872.4880
Advisory panel
Dental
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Special
Location
Waltham, MA, US
Download summary PDFView on FDA.gov ↗

Recent devices under product code DZL

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Adverse events under product code DZL

product code DZL
Injury
168
Total
168

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.