DeviceClearance

LOW PROFILE ABUTMENTS - INTERNAL AND EXTERNAL CONNECTION— 510(k) K092341

Substantially Equivalent

Biomet 3i, Inc.

FDA 510(k) clearance K092341 for LOW PROFILE ABUTMENTS - INTERNAL AND EXTERNAL CONNECTION, Substantially Equivalent on 2009-11-30. Applicant: Biomet 3i, Inc.. Device class: 2.

Clearance details

Applicant
Biomet 3i, Inc.
Product code
Code NHA
Device class
Class 2
Regulation
21 CFR 872.3630
Advisory panel
Dental
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Palm Beach Gardens, FL, US
Download summary PDFView on FDA.gov ↗

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Adverse events under product code NHA

product code NHA
Injury
1,270
Malfunction
2,860
Total
4,130

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 →

Recalls naming K092341

K-number listed on FDA's recall record

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K092341.

Data sourced from openFDA. This site is unofficial and independent of the FDA.