Cleared Traditional

K940914 - NEW LUTING CEMENT MATERIAL (NLC)

K940914 is an FDA 510(k) clearance for NEW LUTING CEMENT MATERIAL (NLC), manufactured by Dentsply Intl.. The device is a Class 2 Dental device with product code EMA cleared through the Traditional 510(k) pathway after a 185-day FDA review.

K940914 · Dentsply Intl. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 1994
Decision
185d
Days
Class 2
Risk

K940914 is an FDA 510(k) clearance for the NEW LUTING CEMENT MATERIAL (NLC). Classified as Cement, Dental (product code EMA), Class II - Special Controls.

Submitted by Dentsply Intl. (York, US). The FDA issued a Cleared decision on August 29, 1994 after a review of 185 days - an extended review 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: 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

FDA 510(k) Submission Details - K940914

510(k) Number K940914 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 25, 1994
Decision Date August 29, 1994
Days to Decision 185 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
58d slower than avg
Panel avg: 127d · This submission: 185d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

EMA Device Classification - Class 2, Special Controls

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 309
Devices cleared under the same product code (EMA) and FDA review panel - the closest regulatory comparables to K940914.
FUJI DUET
K946100 · GC America, Inc. · Jan 1995
PULP CANAL SEALER EWT
K945244 · Sybron Dental Specialties, Inc. · Dec 1994
SEALAPEX
K944480 · Sybron Dental Specialties, Inc. · Nov 1994
ORTHOCENT: LIQUID AND POWDER
K942665 · Dentauraum, Inc. · Jul 1994
DEOX, OXYGEN BARRIER VISCOUS SOLUTION
K941065 · Ultradent Products, Inc. · Jun 1994
ALPHA-LOCK OR PRO-LOCK FLUORIDE RELEASING GLASS IONOMER BAND CEMENT
K942596 · Wallace A. Erickson & Co. · Jun 1994