Cleared Traditional

K022653 - ELITE MONOPHASE

K022653 is an FDA 510(k) clearance for ELITE MONOPHASE, manufactured by Zhermack S.P.A.. The device is a Class 2 Dental device with product code ELW cleared through the Traditional 510(k) pathway after a 80-day FDA review.

K022653 · Zhermack S.P.A. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2002
Decision
80d
Days
Class 2
Risk

K022653 is an FDA 510(k) clearance for the ELITE MONOPHASE. Classified as Material, Impression (product code ELW), Class II - Special Controls.

Submitted by Zhermack S.P.A. (Bend, US). The FDA issued a Cleared decision on October 28, 2002 after a review of 80 days - a notably fast clearance cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3660 - 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 Zhermack S.P.A. devices

FDA 510(k) Submission Details - K022653

510(k) Number K022653 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 09, 2002
Decision Date October 28, 2002
Days to Decision 80 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
47d faster than avg
Panel avg: 127d · This submission: 80d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

ELW Device Classification - Class 2, Special Controls

Product Code ELW Material, Impression
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.3660
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Dental devices follow this clearance model.

Regulatory Peers - ELW Material, Impression

All 237
Devices cleared under the same product code (ELW) and FDA review panel - the closest regulatory comparables to K022653.
OCCLUFAST ROCK
K024034 · Zhermack S.P.A. · Dec 2002
ZETAPLUS SOFT
K024041 · Zhermack S.P.A. · Dec 2002
TULIP ALGINATE IMPRESSION MATERIAL
K023466 · Cavex Holland BV · Dec 2002
ISO FUNCTIONAL
K022430 · GC America, Inc. · Oct 2002
REGISTRADO X-TRA
K022066 · Voco GmbH · Aug 2002
AQUASIL ULTRA MONOPHASE/HEAVY/LV SMART WETTING IMPRESSION MATERIAL
K021416 · Dentsply Intl. · May 2002