Cleared Traditional

TREND SET 2 PLUS (K936070) - FDA 510(k) Clearance

Class II Dental device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K936070 · Confi-Dental Products Co. · Dental device
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Feb 1994
Decision
46d
Days
Class 2
Risk

K936070 is an FDA 510(k) clearance for the TREND SET 2 PLUS. Classified as Material, Impression (product code ELW), Class II - Special Controls.

Submitted by Confi-Dental Products Co. (Louisville, US). The FDA issued a Cleared decision on February 4, 1994 after a review of 46 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 Confi-Dental Products Co. devices

Submission Details

510(k) Number K936070 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 20, 1993
Decision Date February 04, 1994
Days to Decision 46 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
81d faster than avg
Panel avg: 127d · This submission: 46d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 52
Devices cleared under the same product code (ELW) and FDA review panel - the closest regulatory comparables to K936070.
JELTRATE PLUS ANTIMICROBIAL IMPR. MATERIAL
K952614 · Dentsply Intl. · Aug 1996
CAPTURE IMPRESSION MATERIAL
K943574 · Dentsply Intl. · Aug 1994
PRETREATMENT SOLUTION
K940685 · Dentsply Intl. · Apr 1994
FAST SET VINYLPOLYSILOXANE BITE REG. MATERIAL
K932459 · 3M Company · Aug 1993
DICOR CERAMIC INLAY - NEW TECHNIC
K884166 · Dentsply Intl. · Apr 1989
DENTAL ALGINATE IMPRESSION MATERIAL W/ANTI. ADDI.
K883842 · Dentsply Intl. · Mar 1989