Cleared Traditional

K853052 - INTEGRITY

K853052 is the FDA 510(k) clearance for INTEGRITY by Dentsply Intl.. It is a Class 2 Dental device (product code EBG) cleared through the Traditional 510(k) pathway after a 28-day FDA review.

K853052 · Dentsply Intl. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 1985
Decision
28d
Days
Class 2
Risk

K853052 is an FDA 510(k) clearance for the INTEGRITY. Classified as Crown And Bridge, Temporary, Resin (product code EBG), Class II - Special Controls.

Submitted by Dentsply Intl. (York, US). The FDA issued a Cleared decision on August 16, 1985 after a review of 28 days - a notably fast clearance cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3770 - 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 K853052 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 19, 1985
Decision Date August 16, 1985
Days to Decision 28 days
Submission Type Traditional
Review Panel Dental (DE)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
99d faster than avg
Panel avg: 127d · This submission: 28d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code EBG Crown And Bridge, Temporary, Resin
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.3770
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 - EBG Crown And Bridge, Temporary, Resin

All 100
Devices cleared under the same product code (EBG) and FDA review panel - the closest regulatory comparables to K853052.
PROTEMP II
K900436 · Espe GmbH (Us) · Mar 1990
CAVIT-W
K875133 · Espe GmbH (Us) · Mar 1988
MAR BOND
K875145 · Reliance Orthodontic Products, Inc. · Feb 1988
DENTALON
K831077 · Kulzer, Inc. · Sep 1983
PROTEMP
K822452 · Espe GmbH (Us) · Sep 1982
MYERSONS SPEC. CROWN & BRIDGE RESIN
K771602 · Howmedica Corp. · Aug 1977