DeviceClearance

POWERMAX 25, MODEL PM25; POWERMAX 30, MODEL PM30— 510(k) K051547

Substantially Equivalent

Tpc Advanced Technology, Inc.

FDA 510(k) clearance K051547 for POWERMAX 25, MODEL PM25; POWERMAX 30, MODEL PM30, Substantially Equivalent on 2005-07-14. Applicant: Tpc Advanced Technology, Inc.. Device class: 2.

Clearance details

Applicant
Tpc Advanced Technology, Inc.
Product code
Code ELC
Device class
Class 2
Regulation
21 CFR 872.4850
Advisory panel
Dental
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Special
Location
City Of Industry, CA, US
Download summary PDFView on FDA.gov ↗

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Adverse events under product code ELC

product code ELC
Malfunction
1,255
Total
1,255

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.