Cleared Traditional

K974140 - ADHESIVE HYBRID IONOMER CEMENT

K974140 is an FDA 510(k) clearance for ADHESIVE HYBRID IONOMER CEMENT, 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 63-day FDA review.

K974140 · Dentsply Intl. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 1998
Decision
63d
Days
Class 2
Risk

K974140 is an FDA 510(k) clearance for the ADHESIVE HYBRID IONOMER CEMENT. Classified as Cement, Dental (product code EMA), Class II - Special Controls.

Submitted by Dentsply Intl. (York, US). The FDA issued a Cleared decision on January 5, 1998 after a review of 63 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

FDA 510(k) Submission Details - K974140

510(k) Number K974140 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 03, 1997
Decision Date January 05, 1998
Days to Decision 63 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
64d faster than avg
Panel avg: 127d · This submission: 63d
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 432
Devices cleared under the same product code (EMA) and FDA review panel - the closest regulatory comparables to K974140.
CLEARFIL DC CEMENT
K980232 · Kuraray Company, Ltd. · Feb 1998
COMPOLUTE APLICAP
K974458 · Espe Dental-Medizin GmbH & Co.Kg. · Feb 1998
SUPER-DENT INTERMEDIATE RESTORATIVE MATERIAL
K972935 · S.S. White Mfg., Ltd. · Jan 1998
3M DENT SYSTEM II PLUS
K973961 · 3M Company · Dec 1997
PULPDENT DENTASTIC UNO
K974014 · Pulpdent Corp. · Dec 1997
AQUAPLAST PALATAL STENT
K973370 · Wfr/Aquaplast Corp. · Dec 1997