DeviceClearance

BIOMET 3I DENTAL ABUTMENTS AND RESTORATIVE COMPONENTS— 510(k) K072642

Substantially Equivalent

Biomet 3i, Inc.

FDA 510(k) clearance K072642 for BIOMET 3I DENTAL ABUTMENTS AND RESTORATIVE COMPONENTS, Substantially Equivalent on 2007-12-20. 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 K072642

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 K072642.

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