Cleared Traditional

K994024 - EXTENDED STRAIGHT ATTACHMENT

K994024 is an FDA 510(k) clearance for EXTENDED STRAIGHT ATTACHMENT, 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 69-day FDA review.

K994024 · Team Technologies, Inc. · Dental device
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Feb 2000
Decision
69d
Days
Class 1
Risk

K994024 is an FDA 510(k) clearance for the EXTENDED STRAIGHT ATTACHMENT. 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 February 3, 2000 after a review of 69 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 - K994024

510(k) Number K994024 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 26, 1999
Decision Date February 03, 2000
Days to Decision 69 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
58d faster than avg
Panel avg: 127d · This submission: 69d
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 K994024.
E-TYPE STRAIGHT HANDPIECE, MODEL AHP-101
K051077 · Aseptico, Inc. · May 2005
AHP-66 4:1 REDUCTION CONTRANGLE: AHP-88 8:1 REDUCTION CONTRANGLE: AHP-88MP 8:1 REDUCTION CONTRANGLE - PUSH BUTTON
K020137 · Aseptico, Inc. · Mar 2002
SURGICAL CONTRA-ANGEL HANDPIECES TYPES WS-56E,WS-75E/KM,WS-92 E/3,SURGICAL STRAIGHT HANDPIECES TYPES, S-9, S-10, S-11
K011061 · W&H Dentalwerk Buermoos GmbH · Jun 2001
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
SERIES XE, SERIES SE, SERIES TE
K971350 · Micro-Mega Societe Anonyme · Jun 1997