Cleared Traditional

IMD 7GX (K885115) - FDA 510(k) Clearance

Class I Dental device.

K885115 · Medical Dental Technology Co. · Dental device
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Jun 1989
Decision
193d
Days
Class 1
Risk

K885115 is an FDA 510(k) clearance for the IMD 7GX. Classified as Handpiece, Air-powered, Dental (product code EFB), Class I - General Controls.

Submitted by Medical Dental Technology Co. (Ventura, US). The FDA issued a Cleared decision on June 23, 1989 after a review of 193 days - an extended review cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.4200 - 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 Medical Dental Technology Co. devices

Submission Details

510(k) Number K885115 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 12, 1988
Decision Date June 23, 1989
Days to Decision 193 days
Submission Type Traditional
Review Panel Dental (DE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
66d slower than avg
Panel avg: 127d · This submission: 193d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code EFB Handpiece, Air-powered, Dental
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 872.4200
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.