Cleared Traditional

K964177 - KROMALGIN IMPRESSION MATERIAL

K964177 is an FDA 510(k) clearance for KROMALGIN IMPRESSION MATERIAL, manufactured by North American Orthodontic Laboratories, Inc.. The device is a Class 2 Dental device with product code ELW cleared through the Traditional 510(k) pathway after a 73-day FDA review.

K964177 · North American Orthodontic Laboratories, Inc. · Dental device
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Dec 1996
Decision
73d
Days
Class 2
Risk

K964177 is an FDA 510(k) clearance for the KROMALGIN IMPRESSION MATERIAL. Classified as Material, Impression (product code ELW), Class II - Special Controls.

Submitted by North American Orthodontic Laboratories, Inc. (Gainsville, US). The FDA issued a Cleared decision on December 30, 1996 after a review of 73 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 North American Orthodontic Laboratories, Inc. devices

FDA 510(k) Submission Details - K964177

510(k) Number K964177 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 18, 1996
Decision Date December 30, 1996
Days to Decision 73 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
54d faster than avg
Panel avg: 127d · This submission: 73d
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 K964177.
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
CHROMOPRINT CHROMATIC ALGINATE IMPRESSION MATERIAL
K964323 · Fen Dental Mfg., Inc. · Dec 1996
PHASE PLUS
K963609 · Zhermack S.P.A. · Nov 1996
3M PROPLUS SYSTEM
K963766 · 3M Company · Oct 1996