Cleared Traditional

K885115 - IMD 7GX

K885115 is an FDA 510(k) clearance for IMD 7GX, manufactured by Medical Dental Technology Co.. The device is a Class 1 Dental device with product code EFB cleared through the Traditional 510(k) pathway after a 193-day FDA review.

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

FDA 510(k) Submission Details - K885115

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.

EFB Device Classification - Class 1, General Controls

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.

Regulatory Peers - EFB Handpiece, Air-powered, Dental

All 202
Devices cleared under the same product code (EFB) and FDA review panel - the closest regulatory comparables to K885115.
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K850597 · Micro-Aire Surgical Instruments, Inc. · Mar 1985