ULTRADENT CARBON MASK - UPI #342— 510(k) K041047

Substantially Equivalent

Medspring Group, Incorporated

FDA 510(k) clearance K041047 for ULTRADENT CARBON MASK - UPI #342, Substantially Equivalent on 2004-12-01. Applicant: Medspring Group, Incorporated.

Clearance details

Applicant: Medspring Group, Incorporated
Product code: Code FXX
Advisory panel: General, Plastic Surgery
Date received: 2004-04-22
Decision date: 2004-12-01
Decision: Substantially Equivalent
Clearance type: Abbreviated
Location: Bountiful, UT, 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.