Cleared Traditional

K964323 - CHROMOPRINT CHROMATIC ALGINATE IMPRESSION MATERIAL

K964323 is an FDA 510(k) clearance for CHROMOPRINT CHROMATIC ALGINATE IMPRESSI..., manufactured by Fen Dental Mfg., Inc.. The device is a Class 2 Dental device with product code ELW cleared through the Traditional 510(k) pathway after a 47-day FDA review.

K964323 · Fen Dental Mfg., Inc. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 1996
Decision
47d
Days
Class 2
Risk

K964323 is an FDA 510(k) clearance for the CHROMOPRINT CHROMATIC ALGINATE IMPRESSION MATERIAL. Classified as Material, Impression (product code ELW), Class II - Special Controls.

Submitted by Fen Dental Mfg., Inc. (Chicago, US). The FDA issued a Cleared decision on December 16, 1996 after a review of 47 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 Fen Dental Mfg., Inc. devices

FDA 510(k) Submission Details - K964323

510(k) Number K964323 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 30, 1996
Decision Date December 16, 1996
Days to Decision 47 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
80d faster than avg
Panel avg: 127d · This submission: 47d
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 306
Devices cleared under the same product code (ELW) and FDA review panel - the closest regulatory comparables to K964323.
CUTTERSIL COMFORT HARDENER
K965165 · Heraeus Kulzer, Inc. · Mar 1997
PERFECTIM
K964692 · J. Morita USA, Inc. · Feb 1997
KROMALGIN IMPRESSION MATERIAL
K964177 · North American Orthodontic Laboratories, Inc. · Dec 1996
PHASE PLUS
K963609 · Zhermack S.P.A. · Nov 1996
3M PROPLUS SYSTEM
K963766 · 3M Company · Oct 1996
ALGINMAX, ORTHOCHROME
K963205 · American Tooth Industries · Oct 1996