Cleared Traditional

CYANODONT DENTAL CEMENT (K901082) - FDA 510(k) Clearance

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

K901082 · Specialites Septodont · Dental device
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Jul 1990
Decision
124d
Days
Class 2
Risk

K901082 is an FDA 510(k) clearance for the CYANODONT DENTAL CEMENT. Classified as Cement, Dental (product code EMA), Class II - Special Controls.

Submitted by Specialites Septodont (Washington, US). The FDA issued a Cleared decision on July 9, 1990 after a review of 124 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 Specialites Septodont devices

Submission Details

510(k) Number K901082 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 07, 1990
Decision Date July 09, 1990
Days to Decision 124 days
Submission Type Traditional
Review Panel Dental (DE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
3d faster than avg
Panel avg: 127d · This submission: 124d
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 80
Devices cleared under the same product code (EMA) and FDA review panel - the closest regulatory comparables to K901082.
VLC GLASS IONOMER
K913836 · Dentsply Intl. · Oct 1991
3M LUTING CEMENT, PASTE A AND B
K911842 · 3M Company · Jun 1991
CHEMFIL II CAPS
K901524 · Dentsply Intl. · Sep 1990
3M LUTING CEMENT - PASTE A AND PASTE B
K902041 · 3M Company · Jun 1990
BIOMER(R) F COMPOSITE LUTING CEMENT
K896340 · Dentsply Intl. · May 1990
TEMPORARY DENTAL CEMENT
K895487 · Dentsply Intl. · Apr 1990