ALPHA-DENT TISSUE CONDITIONER AND TEMPORARY RELINER— 510(k) K934248

Substantially Equivalent

Wallace A. Erickson & Co.

FDA 510(k) clearance K934248 for ALPHA-DENT TISSUE CONDITIONER AND TEMPORARY RELINER, Substantially Equivalent on 1993-12-08. Applicant: Wallace A. Erickson & Co..

Clearance details

Applicant
Wallace A. Erickson & Co.
Product code
Code EBI
Advisory panel
Dental
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Chicago, IL, US
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Adverse events under product code EBI

product code EBI
Other
1
Total
1

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.