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) Official FDA 510(k) Summary (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.

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
301d slower than avg
Panel avg: 128d · 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 64
Devices cleared under the same product code (EGS) and FDA review panel - the closest regulatory comparables to K022505.
E-TYPE STRAIGHT HANDPIECE, MODEL AHP-101
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K042171 · Micro-Mega Societe Anonyme · Nov 2004
B&R DEVICE
K032925 · Ronvig A/S · Dec 2003
PROANGLE DISPOSABLE PROPHY ANGLE
K030603 · Pac-Dent International (Suzhou), Ltd. · Apr 2003
ST. GEORGE TECHNOLOGY, INC PERFECTION PLUS DISPOSABLE PROPHY ANGLE
K023953 · St. George Technology, Inc. · Feb 2003
CLEAN 'N' OIL
K022264 · Svenska Dental Instruments AB · Oct 2002
K022505 · CONTRA-ANGLE, MODELS 1059, 5050, 5051, 5055, 5056, 5057, 5059, 5060, 5061, 5062, 5063, 5064, 5065, 5066, 5067, 5068,
Download PDF FDA Summary NOUVAG AG