Cleared Traditional

K950555 - J SINGLE USE HEAD AND JD REUSABLE HANDLE

K950555 is an FDA 510(k) clearance for J SINGLE USE HEAD AND JD REUSABLE HANDLE, 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 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.

FDA 510(k) Submission Details - K950555

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
196d slower than avg
Panel avg: 128d · This submission: 324d
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 K950555.
SERIES XE, SERIES SE, SERIES TE
K971350 · Micro-Mega Societe Anonyme · Jun 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
RITE-ANGLE DISPOSABLE PROPHY ANGLES
K954802 · Ash-USA · Nov 1995
ORAL PROCEDURE PACK
K950743 · Transidyne General Corp. · Mar 1995
PROPHYLAXIS PACK
K950773 · Transidyne General Corp. · Mar 1995
K950555 · J SINGLE USE HEAD AND JD REUSABLE HANDLE
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