Cleared Traditional

K973285 - D/SENSE-T

K973285 is the FDA 510(k) clearance for D/SENSE-T by Centrix, Inc.. It is a Class 2 Dental device (product code KLE) cleared through the Traditional 510(k) pathway after a 176-day FDA review.

K973285 · Centrix, Inc. · Dental device
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Feb 1998
Decision
176d
Days
Class 2
Risk

K973285 is an FDA 510(k) clearance for the D/SENSE-T. 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 February 25, 1998 after a review of 176 days - an extended review 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: 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 Centrix, Inc. devices

Submission Details

510(k) Number K973285 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 02, 1997
Decision Date February 25, 1998
Days to Decision 176 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
49d slower than avg
Panel avg: 127d · This submission: 176d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 282
Devices cleared under the same product code (KLE) and FDA review panel - the closest regulatory comparables to K973285.
GC FUJI BOND LC
K981514 · GC America, Inc. · Jun 1998
SOLOBOND M
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PREPQUICK
K974786 · Ultradent Products, Inc. · Mar 1998
GLUMA ONE BOND
K974390 · Heraeus Kulzer, Inc. · Feb 1998
PQ 1
K974283 · Ultradent Products, Inc. · Jan 1998
2 BOND 2
K971733 · Heraeus Kulzer, Inc. · Oct 1997