Cleared Traditional

K955279 - D-SENSE

K955279 is an FDA 510(k) clearance for D-SENSE, manufactured by Centrix, Inc.. The device is a Class 2 Dental device with product code KLE cleared through the Traditional 510(k) pathway after a 42-day FDA review.

K955279 · Centrix, Inc. · Dental device
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Dec 1995
Decision
42d
Days
Class 2
Risk

K955279 is an FDA 510(k) clearance for the D-SENSE. Classified as Agent, Tooth Bonding, Resin (product code KLE), Class II - Special Controls.

Submitted by Centrix, Inc. (Shelton, US). The FDA issued a Cleared decision on December 28, 1995 after a review of 42 days - a notably fast clearance cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3200 - 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 Centrix, Inc. devices

FDA 510(k) Submission Details - K955279

510(k) Number K955279 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 16, 1995
Decision Date December 28, 1995
Days to Decision 42 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
85d faster than avg
Panel avg: 127d · This submission: 42d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KLE Device Classification - Class 2, Special Controls

Product Code KLE Agent, Tooth Bonding, Resin
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.3200
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 - KLE Agent, Tooth Bonding, Resin

All 380
Devices cleared under the same product code (KLE) and FDA review panel - the closest regulatory comparables to K955279.
ALPHA-DENT HEMA DESENTIZER(748-000)/WITH FLUORIDE(747-000)
K960365 · Wallace A. Erickson & Co. · Mar 1996
AMALGAMIBOND PLUS
K960879 · Parkell, Inc. · Mar 1996
GLUFLORMA
K955740 · Midwest Orthodontic Mfg. · Feb 1996
AMERICAN DENTAL PRODUCTS WETTING AGENT & DESENSITIZER
K954133 · American Dental Products, Inc. · Oct 1995
SILANE PRIMER
K954708 · Sybron Dental Specialties, Inc. · Oct 1995
IMPERVA FLUOROBOND
K953612 · Shofu Dental Corp. · Oct 1995