Cleared Traditional

K971350 - SERIES XE, SERIES SE, SERIES TE (FDA 510(k) Clearance)

Class I Dental device.

K971350 · Micro-Mega Societe Anonyme · Dental device
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Jun 1997
Decision
55d
Days
Class 1
Risk

K971350 is an FDA 510(k) clearance for the SERIES XE, SERIES SE, SERIES TE. 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 June 4, 1997 after a review of 55 days - a notably fast clearance 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: 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 Micro-Mega Societe Anonyme devices

Submission Details

510(k) Number K971350 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 10, 1997
Decision Date June 04, 1997
Days to Decision 55 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
72d faster than avg
Panel avg: 127d · This submission: 55d
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.

Regulatory Peers - EGS Handpiece, Contra- And Right-angle Attachment, Dental

All 72
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