Cleared Traditional

K973248 - IMTEC BONE COLLECTOR SYSTEM (FDA 510(k) Clearance)

Class I Dental device.

K973248 · Imtec Corp. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 1997
Decision
82d
Days
Class 1
Risk

K973248 is an FDA 510(k) clearance for the IMTEC BONE COLLECTOR SYSTEM. Classified as Evacuator, Oral Cavity (product code EHZ), Class I - General Controls.

Submitted by Imtec Corp. (Ardmore, US). The FDA issued a Cleared decision on November 19, 1997 after a review of 82 days - a notably fast clearance cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.6640 - 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Imtec Corp. devices

Submission Details

510(k) Number K973248 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 29, 1997
Decision Date November 19, 1997
Days to Decision 82 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
45d faster than avg
Panel avg: 127d · This submission: 82d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code EHZ Evacuator, Oral Cavity
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 872.6640
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.