Cleared Traditional

K904251 - NEW TRIAD VLC CROWN & BRIDGE PROVISIONAL MATERIAL

K904251 is an FDA 510(k) clearance for NEW TRIAD VLC CROWN & BRIDGE PROVISIONA..., manufactured by Dentifax Intern, Inc.. The device is a Class 2 Dental device with product code EBG cleared through the Traditional 510(k) pathway after a 266-day FDA review.

K904251 · Dentifax Intern, Inc. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 1991
Decision
266d
Days
Class 2
Risk

K904251 is an FDA 510(k) clearance for the NEW TRIAD VLC CROWN & BRIDGE PROVISIONAL MATERIAL. Classified as Crown And Bridge, Temporary, Resin (product code EBG), Class II - Special Controls.

Submitted by Dentifax Intern, Inc. (York, US). The FDA issued a Cleared decision on June 6, 1991 after a review of 266 days - an extended review cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3770 - 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Dental review framework, consistent with the majority of Class II 510(k) submissions.

View all Dentifax Intern, Inc. devices

FDA 510(k) Submission Details - K904251

510(k) Number K904251 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 13, 1990
Decision Date June 06, 1991
Days to Decision 266 days
Submission Type Traditional
Review Panel Dental (DE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
139d slower than avg
Panel avg: 127d · This submission: 266d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

EBG Device Classification - Class 2, Special Controls

Product Code EBG Crown And Bridge, Temporary, Resin
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.3770
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 - EBG Crown And Bridge, Temporary, Resin

All 166
Devices cleared under the same product code (EBG) and FDA review panel - the closest regulatory comparables to K904251.
PALAVIT 55 AND DENTACOLOR CONNECTOR
K932034 · Heraeus Kulzer, Inc. · Aug 1993
ACUFEX ENDOFIX BUTTON
K922559 · Acufex Microsurgical, Inc. · Dec 1992
SEPTOPACK TEMPORARY FILLING
K915466 · Specialites Septodont · Feb 1992
DENTALON PLUS
K903317 · Kulzer, Inc. · Aug 1990
PRELUDE (TEMPORARY CROWN AND BRIDGE CEMENT)
K901077 · Scientific Pharmaceuticals, Inc. · May 1990
PROTEMP II
K900436 · Espe GmbH (Us) · Mar 1990