Cleared Traditional

K941189 - DISPOSABLE PROPHYLAXIS ANGLE

K941189 is an FDA 510(k) clearance for DISPOSABLE PROPHYLAXIS ANGLE, manufactured by Team Technologies, Inc.. The device is a Class 1 Dental device with product code EGS cleared through the Traditional 510(k) pathway after a 63-day FDA review.

K941189 · Team Technologies, Inc. · Dental device
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May 1994
Decision
63d
Days
Class 1
Risk

K941189 is an FDA 510(k) clearance for the DISPOSABLE PROPHYLAXIS ANGLE. Classified as Handpiece, Contra- And Right-angle Attachment, Dental (product code EGS), Class I - General Controls.

Submitted by Team Technologies, Inc. (Morristown, US). The FDA issued a Cleared decision on May 16, 1994 after a review of 63 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 Team Technologies, Inc. devices

FDA 510(k) Submission Details - K941189

510(k) Number K941189 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 14, 1994
Decision Date May 16, 1994
Days to Decision 63 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
64d faster than avg
Panel avg: 127d · This submission: 63d
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 32
Devices cleared under the same product code (EGS) and FDA review panel - the closest regulatory comparables to K941189.
ORAL PROCEDURE PACK
K950743 · Transidyne General Corp. · Mar 1995
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
TORX HANDPIECE CONTRA ANGLES ATTACHMENTS
K801688 · Pacific Dental Corp. · Aug 1980
HANDPIECE, LIFT, ENDO
K780213 · Kerr Corporation (Danbury) · Feb 1978