Cleared Traditional

K942666 - ORTHALGENAT IMPRESSION MATERIAL

K942666 is an FDA 510(k) clearance for ORTHALGENAT IMPRESSION MATERIAL, manufactured by Dentauraum, Inc.. 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.

K942666 · Dentauraum, Inc. · Dental device
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Aug 1994
Decision
65d
Days
Class 2
Risk

K942666 is an FDA 510(k) clearance for the ORTHALGENAT IMPRESSION MATERIAL. Classified as Material, Impression (product code ELW), Class II - Special Controls.

Submitted by Dentauraum, Inc. (Newtown, US). The FDA issued a Cleared decision on August 10, 1994 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 Dentauraum, Inc. devices

FDA 510(k) Submission Details - K942666

510(k) Number K942666 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 06, 1994
Decision Date August 10, 1994
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 195
Devices cleared under the same product code (ELW) and FDA review panel - the closest regulatory comparables to K942666.
DENTRAY II PLUS TRAY ADHESIVE
K952930 · Confi-Dental Products Co. · Sep 1995
GC SURFLEX F
K943388 · GC America, Inc. · Sep 1994
CAPTURE IMPRESSION MATERIAL
K943574 · Dentsply Intl. · Aug 1994
CHROMACLONE COLOR CHANGING ALGINATE IMPRESS MATERIALS
K940860 · Ultradent Products, Inc. · May 1994
PRETREATMENT SOLUTION
K940685 · Dentsply Intl. · Apr 1994
HYDROCOLLOID HEATING UNIT
K935151 · Centrix, Inc. · Apr 1994