Cleared Traditional

K952240 - TOOTH PREPARATION CONDITIONER

K952240 is an FDA 510(k) clearance for TOOTH PREPARATION CONDITIONER, manufactured by Jeneric/Pentron, Inc.. The device is a Class 2 Dental device with product code EBC cleared through the Traditional 510(k) pathway after a 98-day FDA review.

K952240 · Jeneric/Pentron, Inc. · Dental device
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Aug 1995
Decision
98d
Days
Class 2
Risk

K952240 is an FDA 510(k) clearance for the TOOTH PREPARATION CONDITIONER, PRE-IMPRESSION. Classified as Sealant, Pit And Fissure, And Conditioner (product code EBC), Class II - Special Controls.

Submitted by Jeneric/Pentron, Inc. (Wallingford, US). The FDA issued a Cleared decision on August 18, 1995 after a review of 98 days - within the typical 510(k) review window.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3765 - 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 Jeneric/Pentron, Inc. devices

FDA 510(k) Submission Details - K952240

510(k) Number K952240 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 12, 1995
Decision Date August 18, 1995
Days to Decision 98 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
29d faster than avg
Panel avg: 127d · This submission: 98d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

EBC Device Classification - Class 2, Special Controls

Product Code EBC Sealant, Pit And Fissure, And Conditioner
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.3765
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 - EBC Sealant, Pit And Fissure, And Conditioner

All 85
Devices cleared under the same product code (EBC) and FDA review panel - the closest regulatory comparables to K952240.
GLY-ETCH
K961190 · Centrix, Inc. · Apr 1996
SEALITE FL
K954827 · Sybron Dental Specialties, Inc. · Jan 1996
AMERICAN DENTAL PRODUCTS PIT & FISSUE SEALANT LIGHT CURING
K954701 · American Dental Products, Inc. · Oct 1995
DELTON F PIT & FISSURE SEALANT
K951296 · Dentsply Intl. · May 1995
PULPDENT CHEMICAL CURE PIT AND FISSURE SEALANT
K945378 · Pulpdent Corp. · Jan 1995
PULPDENT SEAL-RITE LOW VISCOSITY
K932794 · Pulpdent Corp. · Sep 1993