Cleared Traditional

K950743 - ORAL PROCEDURE PACK

K950743 is an FDA 510(k) clearance for ORAL PROCEDURE PACK, manufactured by Transidyne General Corp.. The device is a Class 1 Dental device with product code EGS cleared through the Traditional 510(k) pathway after a 42-day FDA review.

K950743 · Transidyne General Corp. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 1995
Decision
42d
Days
Class 1
Risk

K950743 is an FDA 510(k) clearance for the ORAL PROCEDURE PACK. Classified as Handpiece, Contra- And Right-angle Attachment, Dental (product code EGS), Class I - General Controls.

Submitted by Transidyne General Corp. (Spartanburg, US). The FDA issued a Cleared decision on March 31, 1995 after a review of 42 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 Transidyne General Corp. devices

FDA 510(k) Submission Details - K950743

510(k) Number K950743 FDA.gov
FDA Decision Cleared Substantially Equivalent - Special 510(k) (SESK)
Date Received February 17, 1995
Decision Date March 31, 1995
Days to Decision 42 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
85d faster than avg
Panel avg: 127d · This submission: 42d
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 43
Devices cleared under the same product code (EGS) and FDA review panel - the closest regulatory comparables to K950743.
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
PROPHYLAXIS PACK
K950773 · Transidyne General Corp. · Mar 1995
M4 CONTRA-ANGLE HANDPIECE
K942480 · Kerr Corporation (Danbury) · Jan 1995
CANAL FINDER
K850294 · Roseburg SA · Jun 1985