Cleared Traditional

K884740 - EURO-MED LIGHT TOUCH BIOPSY PUNCH

K884740 is an FDA 510(k) clearance for EURO-MED LIGHT TOUCH BIOPSY PUNCH, manufactured by Buckman Co., Inc.. The device is a Class 1 Dental device with product code EME cleared through the Traditional 510(k) pathway after a 112-day FDA review.

K884740 · Buckman Co., Inc. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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

FDA 510(k) Submission Details - K884740

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
15d faster than avg
Panel avg: 127d · This submission: 112d
Pathway characteristics
Predicate-based equivalence.

EME Device Classification - Class 1, General Controls

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.