Cleared Traditional

K884740 - EURO-MED LIGHT TOUCH BIOPSY PUNCH (FDA 510(k) Clearance)

Class I Dental device.

K884740 · Buckman Co., Inc. · Dental device
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Mar 1989
Decision
112d
Days
Class 1
Risk

K884740 is an FDA 510(k) clearance for the EURO-MED LIGHT TOUCH BIOPSY PUNCH. Classified as Punch, Biopsy, Surgical (product code EME), Class I - General Controls.

Submitted by Buckman Co., Inc. (Martinez, US). The FDA issued a Cleared decision on March 6, 1989 after a review of 112 days - within the typical 510(k) review window.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.4565 - the FDA dental device regulatory framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Dental review framework, consistent with the majority of Class II 510(k) submissions.

View all Buckman Co., Inc. devices

Submission Details

510(k) Number K884740 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 14, 1988
Decision Date March 06, 1989
Days to Decision 112 days
Submission Type Traditional
Review Panel Dental (DE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
15d faster than avg
Panel avg: 127d · This submission: 112d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code EME Punch, Biopsy, Surgical
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 872.4565
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.