Cleared Traditional

K972573 - LIQCRYLIC PRO DENTAL RESIN

K972573 is the FDA 510(k) clearance for LIQCRYLIC PRO DENTAL RESIN by Dentsply Intl.. It is a Class 2 Dental device (product code EBI) cleared through the Traditional 510(k) pathway after a 68-day FDA review.

K972573 · Dentsply Intl. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 1997
Decision
68d
Days
Class 2
Risk

K972573 is an FDA 510(k) clearance for the LIQCRYLIC PRO DENTAL RESIN. Classified as Resin, Denture, Relining, Repairing, Rebasing (product code EBI), Class II - Special Controls.

Submitted by Dentsply Intl. (York, US). The FDA issued a Cleared decision on September 16, 1997 after a review of 68 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 Dentsply Intl. devices

Submission Details

510(k) Number K972573 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 10, 1997
Decision Date September 16, 1997
Days to Decision 68 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
59d faster than avg
Panel avg: 127d · This submission: 68d
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 149
Devices cleared under the same product code (EBI) and FDA review panel - the closest regulatory comparables to K972573.
KERR HARD DENTURE RELINE MATERIAL
K981448 · Sybron Dental Specialties, Inc. · Jun 1998
CSR
K974865 · Parkell, Inc. · Mar 1998
UFI GEL C
K974772 · Voco GmbH · Feb 1998
TRUBYTE SOFT RELINE SYSTEM
K964040 · Dentsply Intl. · Dec 1996
SOFT DENTURE REBASING RESIN
K963736 · Sybron Dental Specialties, Inc. · Dec 1996
GC BASELINE
K963144 · GC America, Inc. · Oct 1996