MOSTDI DENTAL IMPLANT SYSTEM— 510(k) K132178

Substantially Equivalent

Mostdi Innovations Sdn Bhd

FDA 510(k) clearance K132178 for MOSTDI DENTAL IMPLANT SYSTEM, Substantially Equivalent on 2014-04-30. Applicant: Mostdi Innovations Sdn Bhd.

Clearance details

Applicant
Mostdi Innovations Sdn Bhd
Product code
Code DZE
Advisory panel
Dental
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Brea, CA, US
Download summary PDFView on FDA.gov ↗

Adverse events under product code DZE

product code DZE
Death
28
Injury
3,367,041
Malfunction
19,958
Other
13
Total
3,387,040

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.