Cleared Traditional

LIGHT-CURED PERIODONTAL DRESSING (K864720) - FDA 510(k) Clearance

Class II Dental device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K864720 · Dentsply Intl. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 1987
Decision
125d
Days
Class 2
Risk

K864720 is an FDA 510(k) clearance for the LIGHT-CURED PERIODONTAL DRESSING. Classified as Cement, Dental (product code EMA), Class II - Special Controls.

Submitted by Dentsply Intl. (York, US). The FDA issued a Cleared decision on April 7, 1987 after a review of 125 days - within the typical 510(k) review window.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3275 - 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 Dentsply Intl. devices

Submission Details

510(k) Number K864720 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 03, 1986
Decision Date April 07, 1987
Days to Decision 125 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
2d faster than avg
Panel avg: 127d · This submission: 125d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code EMA Cement, Dental
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.3275
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 - EMA Cement, Dental

All 79
Devices cleared under the same product code (EMA) and FDA review panel - the closest regulatory comparables to K864720.
BIOMER(R) F COMPOSITE LUTING CEMENT
K896340 · Dentsply Intl. · May 1990
TEMPORARY DENTAL CEMENT
K895487 · Dentsply Intl. · Apr 1990
CEMENT LINER
K874945 · Dentsply Intl. · Feb 1988
BONDEX* GLASS IONOMER CEMENT
K870211 · Johnson & Johnson Professionals, Inc. · Mar 1987
MODI. DICOR CASTABLE CERAMIC/ALL PORCELAIN BRIDGES
K864725 · Dentsply Intl. · Jan 1987
3M GLASS IONOMER LINER
K864270 · 3M Company · Dec 1986