PHOENIX STERI-TECH STERILE DENTAL PACK GEN-10001— 510(k) K920682

Substantially Equivalent

Phoenix Steri-Tech, Inc.

FDA 510(k) clearance K920682 for PHOENIX STERI-TECH STERILE DENTAL PACK GEN-10001, Substantially Equivalent on 1992-04-28. Applicant: Phoenix Steri-Tech, Inc..

Clearance details

Applicant: Phoenix Steri-Tech, Inc.
Product code: Code FXX
Advisory panel: General, Plastic Surgery
Date received: 1992-02-14
Decision date: 1992-04-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Suwanee, GA, US

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Adverse events under product code FXX

product code FXX

Injury: 137
Total: 137

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. 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.