Cleared Traditional

K891607 - DENTANURSE

K891607 is an FDA 510(k) clearance for DENTANURSE, manufactured by The Irish Scene. The device is a Class 2 Dental device with product code EMA cleared through the Traditional 510(k) pathway after a 144-day FDA review.

K891607 · The Irish Scene · Dental device
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Aug 1989
Decision
144d
Days
Class 2
Risk

K891607 is an FDA 510(k) clearance for the DENTANURSE. Classified as Cement, Dental (product code EMA), Class II - Special Controls.

Submitted by The Irish Scene (Stamford, US). The FDA issued a Cleared decision on August 11, 1989 after a review of 144 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 The Irish Scene devices

FDA 510(k) Submission Details - K891607

510(k) Number K891607 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 20, 1989
Decision Date August 11, 1989
Days to Decision 144 days
Submission Type Traditional
Review Panel Dental (DE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
17d slower than avg
Panel avg: 127d · This submission: 144d
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 437
Devices cleared under the same product code (EMA) and FDA review panel - the closest regulatory comparables to K891607.
SILCOT COPAL CAVITY VARNISH
K895798 · Specialites Septodont · Dec 1989
KULZER GLAS-IONOMER CEMENT
K892453 · Kulzer, Inc. · Dec 1989
TEMP BOND NE
K894219 · Kerr Corporation (Danbury) · Sep 1989
CIMPAT S TEMPORARY DENTAL CEMENT
K885007 · Specialites Septodont · Mar 1989
CHELON-FIL
K884475 · Espe GmbH (Us) · Dec 1988
INTERIM, TEMPORARY CEMENT
K884081 · Scientific Pharmaceuticals, Inc. · Dec 1988