Cleared Traditional

K881245 - DENT-URE LINER SOFT RESILIENT DENTURE LINING MATER

K881245 is an FDA 510(k) clearance for DENT-URE LINER SOFT RESILIENT DENTURE L..., manufactured by Cadco Dental Products, Inc.. The device is a Class 2 Dental device with product code EBI cleared through the Traditional 510(k) pathway after a 120-day FDA review.

K881245 · Cadco Dental Products, Inc. · Dental device
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Jul 1988
Decision
120d
Days
Class 2
Risk

K881245 is an FDA 510(k) clearance for the DENT-URE LINER SOFT RESILIENT DENTURE LINING MATER. Classified as Resin, Denture, Relining, Repairing, Rebasing (product code EBI), Class II - Special Controls.

Submitted by Cadco Dental Products, Inc. (Los Angeles, US). The FDA issued a Cleared decision on July 21, 1988 after a review of 120 days - within the typical 510(k) review window.

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: 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 Cadco Dental Products, Inc. devices

FDA 510(k) Submission Details - K881245

510(k) Number K881245 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 23, 1988
Decision Date July 21, 1988
Days to Decision 120 days
Submission Type Traditional
Review Panel Dental (DE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
8d faster than avg
Panel avg: 128d · This submission: 120d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

EBI Device Classification - Class 2, Special Controls

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 265
Devices cleared under the same product code (EBI) and FDA review panel - the closest regulatory comparables to K881245.
DENTURE RESIN
K890830 · G-C Intl. Corp. · May 1989
BASE, DENTURE, RELINING, REPAIRING, REBASING,RESIN
K883799 · Austenal Dental, Inc. · Oct 1988
TRIAD ORTHODONTIC GEL
K882482 · Dentsply Intl. · Aug 1988
LIGHT CURE DENTURE GLAZE
K871849 · Austenal Dental, Inc. · Aug 1987
AUSTENAL ACUPAC 20 DENTURE BASE MATERIAL
K863630 · Austenal Dental, Inc. · Mar 1987
AUSTENAL ACUSOFT SOFT LINER
K862557 · Austenal Dental, Inc. · Feb 1987