Cleared Traditional

K915467 - CIMPAT S DENTAL CEMENT

K915467 is the FDA 510(k) clearance for CIMPAT S DENTAL CEMENT by Specialites Septodont. It is a Class 2 Dental device (product code EMA) cleared through the Traditional 510(k) pathway after a 60-day FDA review.

K915467 · Specialites Septodont · Dental device
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Feb 1992
Decision
60d
Days
Class 2
Risk

K915467 is an FDA 510(k) clearance for the CIMPAT S 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 February 3, 1992 after a review of 60 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 Specialites Septodont devices

Submission Details

510(k) Number K915467 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 05, 1991
Decision Date February 03, 1992
Days to Decision 60 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
67d faster than avg
Panel avg: 127d · This submission: 60d
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 287
Devices cleared under the same product code (EMA) and FDA review panel - the closest regulatory comparables to K915467.
PROVICOL
K915618 · Voco GmbH · Feb 1992
IONOFIL/LONOFIL MOLAR
K915619 · Voco GmbH · Feb 1992
MERON DENTAL CEMENT
K914612 · Voco GmbH · Feb 1992
PHOTAC-BOND APLICAP, MODIFICATION
K915005 · Espe GmbH (Us) · Jan 1992
CAVITY VARNISH PRODUCT
K914324 · Confi-Dental Products Co. · Dec 1991
F21(R) DENTAL CEMENT
K914073 · Voco GmbH · Oct 1991