Cleared Traditional

K971350 - SERIES XE, SERIES SE, SERIES TE

K971350 is an FDA 510(k) clearance for SERIES XE, manufactured by Micro-Mega Societe Anonyme. The device is a Class 1 Dental device with product code EGS cleared through the Traditional 510(k) pathway after a 55-day FDA review.

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.

FDA 510(k) Submission Details - K971350

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
73d faster than avg
Panel avg: 128d · This submission: 55d
Pathway characteristics
Predicate-based equivalence.

EGS Device Classification - Class 1, General Controls

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 64
Devices cleared under the same product code (EGS) and FDA review panel - the closest regulatory comparables to K971350.
STARDENTAL TITAN 3 LUBEFREE MOTOR ATTACHMENTS
K983574 · Dentalez Group · Jan 1999
23:1 REDUCTION ANGLE
K973800 · Midwest Dental Products Corp. · Mar 1998
E-TYPE SPEED INCREASER CONTRA ANGLE, EXTERNAL IRRIGATION, INTERNAL IRRIGATION
K972569 · Nsk Nakanishi, Inc. · Oct 1997
E-TYPE CONTRA ANGLE NAC-E
K962540 · Nsk Nakanishi, Inc. · Sep 1996
SERIES XE 140XE,40XE,10XE/SERIES SE 140SE,40SE,10SE/SERIES 10TE
K961494 · Micro-Mega Societe Anonyme · Jun 1996
J SINGLE USE HEAD AND JD REUSABLE HANDLE
K950555 · Micro-Mega Societe Anonyme · Dec 1995
K971350 · SERIES XE, SERIES SE, SERIES TE
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