Cleared Traditional

K973002 - HURRISEAL DENTIN DESENSITIZER

K973002 is an FDA 510(k) clearance for HURRISEAL DENTIN DESENSITIZER, manufactured by Cheng & Assoc., Inc.. The device is a Class 2 Dental device with product code KLE cleared through the Traditional 510(k) pathway after a 223-day FDA review.

K973002 · Cheng & Assoc., Inc. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 1998
Decision
223d
Days
Class 2
Risk

K973002 is an FDA 510(k) clearance for the HURRISEAL DENTIN DESENSITIZER. Classified as Agent, Tooth Bonding, Resin (product code KLE), Class II - Special Controls.

Submitted by Cheng & Assoc., Inc. (Chicago, US). The FDA issued a Cleared decision on March 23, 1998 after a review of 223 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 Cheng & Assoc., Inc. devices

FDA 510(k) Submission Details - K973002

510(k) Number K973002 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 12, 1997
Decision Date March 23, 1998
Days to Decision 223 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
96d slower than avg
Panel avg: 127d · This submission: 223d
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 372
Devices cleared under the same product code (KLE) and FDA review panel - the closest regulatory comparables to K973002.
ALLOYBOND
K981383 · Southern Dental Industries, Inc. · Jun 1998
GC FUJI BOND LC
K981514 · GC America, Inc. · Jun 1998
ONE COAT BOND DENTIN/ENAMEL ADHESIVE SYSTEM
K974906 · Coltene/Whaledent, Inc. · Mar 1998
SOLOBOND M
K980539 · Voco GmbH · Mar 1998
PREPQUICK
K974786 · Ultradent Products, Inc. · Mar 1998
D/SENSE-T
K973285 · Centrix, Inc. · Feb 1998