Cleared Traditional

K963609 - PHASE PLUS

K963609 is an FDA 510(k) clearance for PHASE PLUS, 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 65-day FDA review.

K963609 · Zhermack S.P.A. · Dental device
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Nov 1996
Decision
65d
Days
Class 2
Risk

K963609 is an FDA 510(k) clearance for the PHASE PLUS. Classified as Material, Impression (product code ELW), Class II - Special Controls.

Submitted by Zhermack S.P.A. (St Louis, US). The FDA issued a Cleared decision on November 14, 1996 after a review of 65 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 - K963609

510(k) Number K963609 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 10, 1996
Decision Date November 14, 1996
Days to Decision 65 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
62d faster than avg
Panel avg: 127d · This submission: 65d
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 K963609.
CUTTERSIL COMFORT
K965163 · Heraeus Kulzer, Inc. · Mar 1997
CUTTERSIL COMFORT HARDENER
K965165 · Heraeus Kulzer, Inc. · Mar 1997
PERFECTIM
K964692 · J. Morita USA, Inc. · Feb 1997
3M PROPLUS SYSTEM
K963766 · 3M Company · Oct 1996
TRI-PHASIX CHROMATIC ALGINATE
K962741 · Parkell, Inc. · Sep 1996
JELTRATE PLUS ANTIMICROBIAL IMPR. MATERIAL
K952614 · Dentsply Intl. · Aug 1996