Cleared Traditional

PROP. CONQUEST C&B VLC GLAZE/SEALANT (K953381) - FDA 510(k) Clearance

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

K953381 · Jeneric/Pentron, Inc. · Dental device
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Sep 1995
Decision
70d
Days
Class 2
Risk

K953381 is an FDA 510(k) clearance for the PROP. CONQUEST C&B VLC GLAZE/SEALANT. Classified as Resin, Denture, Relining, Repairing, Rebasing (product code EBI), Class II - Special Controls.

Submitted by Jeneric/Pentron, Inc. (Wallingford, US). The FDA issued a Cleared decision on September 27, 1995 after a review of 70 days - a notably fast clearance cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3760 - 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 Jeneric/Pentron, Inc. devices

Submission Details

510(k) Number K953381 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 19, 1995
Decision Date September 27, 1995
Days to Decision 70 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
57d faster than avg
Panel avg: 127d · This submission: 70d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code EBI Resin, Denture, Relining, Repairing, Rebasing
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.3760
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 - EBI Resin, Denture, Relining, Repairing, Rebasing

All 112
Devices cleared under the same product code (EBI) and FDA review panel - the closest regulatory comparables to K953381.
GC BASELINE
K963144 · GC America, Inc. · Oct 1996
QUICKSPLINT
K961995 · Heraeus Kulzer, Inc. · Jun 1996
PALASPLINT
K953743 · Heraeus Kulzer, Inc. · Oct 1995
PRECISE DENTURE BASE RESIN
K952351 · Dentsply Intl. · Jul 1995
COE-SOFT LC
K940565 · GC America, Inc. · May 1994
KOOLINER II
K935261 · GC America, Inc. · Jan 1994