E-TYPE CONTRA ANGLE NAC-E— 510(k) K962540

Substantially Equivalent

Nsk Nakanishi, Inc.

FDA 510(k) clearance K962540 for E-TYPE CONTRA ANGLE NAC-E, Substantially Equivalent on 1996-09-12. Applicant: Nsk Nakanishi, Inc.. Device class: 1.

Clearance details

Applicant
Nsk Nakanishi, Inc.
Product code
Code EGS
Device class
Class 1
Regulation
21 CFR 872.4200
Advisory panel
Dental
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Tochigi-Ken, JP
Download summary PDFView on FDA.gov ↗

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Adverse events under product code EGS

product code EGS
Injury
356
Malfunction
759
Total
1,115

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.