Cleared Traditional

K892710 - ARISTEE (TEMPORARY CROWN & BRIDGE RESIN)

K892710 is an FDA 510(k) clearance for ARISTEE (TEMPORARY CROWN & BRIDGE RESIN), manufactured by Prometex, Inc.. The device is a Class 2 Dental device with product code EBG cleared through the Traditional 510(k) pathway after a 193-day FDA review.

K892710 · Prometex, Inc. · Dental device
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Oct 1989
Decision
193d
Days
Class 2
Risk

K892710 is an FDA 510(k) clearance for the ARISTEE (TEMPORARY CROWN & BRIDGE RESIN). Classified as Crown And Bridge, Temporary, Resin (product code EBG), Class II - Special Controls.

Submitted by Prometex, Inc. (Houston, US). The FDA issued a Cleared decision on October 24, 1989 after a review of 193 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 Prometex, Inc. devices

FDA 510(k) Submission Details - K892710

510(k) Number K892710 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 14, 1989
Decision Date October 24, 1989
Days to Decision 193 days
Submission Type Traditional
Review Panel Dental (DE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
66d slower than avg
Panel avg: 127d · This submission: 193d
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 110
Devices cleared under the same product code (EBG) and FDA review panel - the closest regulatory comparables to K892710.
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
CAVIT-W
K875133 · Espe GmbH (Us) · Mar 1988
MAR BOND
K875145 · Reliance Orthodontic Products, Inc. · Feb 1988
INTEGRITY
K853052 · Dentsply Intl. · Aug 1985