Cleared Traditional

K896340 - BIOMER(R) F COMPOSITE LUTING CEMENT

K896340 is an FDA 510(k) clearance for BIOMER F COMPOSITE LUTING 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 193-day FDA review.

K896340 · Dentsply Intl. · Dental device
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May 1990
Decision
193d
Days
Class 2
Risk

K896340 is an FDA 510(k) clearance for the BIOMER(R) F COMPOSITE LUTING 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 May 15, 1990 after a review of 193 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 - K896340

510(k) Number K896340 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 03, 1989
Decision Date May 15, 1990
Days to Decision 193 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
66d slower than avg
Panel avg: 127d · This submission: 193d
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 433
Devices cleared under the same product code (EMA) and FDA review panel - the closest regulatory comparables to K896340.
CYANODONT DENTAL CEMENT
K901082 · Specialites Septodont · Jul 1990
GC CERVICAL CEMENT
K896883 · G-C Intl. Corp. · Jul 1990
3M LUTING CEMENT - PASTE A AND PASTE B
K902041 · 3M Company · Jun 1990
GLASION
K895386 · Scientific Pharmaceuticals, Inc. · Apr 1990
TEMPORARY DENTAL CEMENT
K895487 · Dentsply Intl. · Apr 1990
KETAC-CEM MAXICAP
K897188 · Espe GmbH (Us) · Mar 1990