Cleared Traditional

K022505 - CONTRA-ANGLE, MODELS 1059, 5050, 5051, 5055, 5056, 5057, 5059, 5060, 5061, 5062, 5063, 5064, 5065, 5066, 5067, 5068,

K022505 is an FDA 510(k) clearance for CONTRA-ANGLE, manufactured by NOUVAG AG. The device is a Class 1 Dental device with product code EGS cleared through the Traditional 510(k) pathway after a 429-day FDA review.

K022505 · NOUVAG AG · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2003
Decision
429d
Days
Class 1
Risk

K022505 is an FDA 510(k) clearance for the CONTRA-ANGLE, MODELS 1059, 5050, 5051, 5055, 5056, 5057, 5059, 5060, 5061, 50.... Classified as Handpiece, Contra- And Right-angle Attachment, Dental (product code EGS), Class I - General Controls.

Submitted by NOUVAG AG (Gebenstorf, CH). The FDA issued a Cleared decision on October 1, 2003 after a review of 429 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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Dental submissions.

View all NOUVAG AG devices

FDA 510(k) Submission Details - K022505

510(k) Number K022505 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 29, 2002
Decision Date October 01, 2003
Days to Decision 429 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
302d slower than avg
Panel avg: 127d · This submission: 429d
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 33
Devices cleared under the same product code (EGS) and FDA review panel - the closest regulatory comparables to K022505.
TORQTECH
K103697 · J. Morita USA, Inc. · Jan 2012
STRONG DENTAL HANDPIECES
K100192 · Saeshin Precision Co., Ltd. · Feb 2010
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
STARDENTAL TITAN 3 LUBEFREE MOTOR ATTACHMENTS
K983574 · Dentalez Group · Jan 1999