Cleared Traditional

K950555 - J SINGLE USE HEAD AND JD REUSABLE HANDLE

K950555 is the FDA 510(k) clearance for J SINGLE USE HEAD AND JD REUSABLE HANDLE by Micro-Mega Societe Anonyme. It is a Class 1 Dental device (product code EGS) cleared through the Traditional 510(k) pathway after a 324-day FDA review.

K950555 · Micro-Mega Societe Anonyme · Dental device
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Dec 1995
Decision
324d
Days
Class 1
Risk

K950555 is an FDA 510(k) clearance for the J SINGLE USE HEAD AND JD REUSABLE HANDLE. Classified as Handpiece, Contra- And Right-angle Attachment, Dental (product code EGS), Class I - General Controls.

Submitted by Micro-Mega Societe Anonyme (Besancon, FR). The FDA issued a Cleared decision on December 28, 1995 after a review of 324 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 Micro-Mega Societe Anonyme devices

Submission Details

510(k) Number K950555 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 07, 1995
Decision Date December 28, 1995
Days to Decision 324 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
197d slower than avg
Panel avg: 127d · This submission: 324d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code EGS Handpiece, Contra- And Right-angle Attachment, 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.