Cleared Traditional

K952930 - DENTRAY II PLUS TRAY ADHESIVE

K952930 is the FDA 510(k) clearance for DENTRAY II PLUS TRAY ADHESIVE by Confi-Dental Products Co.. It is a Class 2 Dental device (product code ELW) cleared through the Traditional 510(k) pathway after a 81-day FDA review.

K952930 · Confi-Dental Products Co. · Dental device
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Sep 1995
Decision
81d
Days
Class 2
Risk

K952930 is an FDA 510(k) clearance for the DENTRAY II PLUS TRAY ADHESIVE. 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 September 8, 1995 after a review of 81 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 K952930 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 19, 1995
Decision Date September 08, 1995
Days to Decision 81 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
46d faster than avg
Panel avg: 127d · This submission: 81d
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 156
Devices cleared under the same product code (ELW) and FDA review panel - the closest regulatory comparables to K952930.
BOSWORTH IMPRESSION MATERIAL I
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RETRAC
K952728 · Centrix, Inc. · 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