Cleared Traditional

K940459 - MULTIPURPOSE RESIN CEMENT WITH FLUORIDE...

K940459 is the FDA 510(k) clearance for MULTIPURPOSE RESIN CEMENT WITH FLUORIDE... by Dentsply Intl.. It is a Class 2 Dental device (product code EMA) cleared through the Traditional 510(k) pathway after a 87-day FDA review.

K940459 · Dentsply Intl. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 1994
Decision
87d
Days
Class 2
Risk

K940459 is an FDA 510(k) clearance for the MULTIPURPOSE RESIN CEMENT WITH FLUORIDE (MRCF). 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 29, 1994 after a review of 87 days - a notably fast clearance cycle.

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: 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 K940459 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 01, 1994
Decision Date April 29, 1994
Days to Decision 87 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
40d faster than avg
Panel avg: 127d · This submission: 87d
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 291
Devices cleared under the same product code (EMA) and FDA review panel - the closest regulatory comparables to K940459.
ALPHA-LOCK OR PRO-LOCK FLUORIDE RELEASING GLASS IONOMER BAND CEMENT
K942596 · Wallace A. Erickson & Co. · Jun 1994
ALPHA-DENT GLASS IONOMER CEMENT, SELF CURED
K935436 · Wallace A. Erickson & Co. · Jun 1994
HY BOND, GLASIONOMER CX
K940122 · Shofu Dental Corp. · May 1994
GRANITEC IONOMER RESIN CEMENT
K940546 · Confi-Dental Products Co. · Apr 1994
BISCO COMPOSITE
K940030 · Bisco, Inc. · Feb 1994
PRECEDENT
K934405 · Reliance Orthodontic Products, Inc. · Jan 1994