Cleared Traditional

PULPDENT OX-OUT (K972445) - FDA 510(k) Clearance

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

K972445 · Pulpdent Corp. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 1997
Decision
94d
Days
Class 2
Risk

K972445 is an FDA 510(k) clearance for the PULPDENT OX-OUT. Classified as Cement, Dental (product code EMA), Class II - Special Controls.

Submitted by Pulpdent Corp. (Watertown, US). The FDA issued a Cleared decision on October 2, 1997 after a review of 94 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 Pulpdent Corp. devices

Submission Details

510(k) Number K972445 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 30, 1997
Decision Date October 02, 1997
Days to Decision 94 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
33d faster than avg
Panel avg: 127d · This submission: 94d
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 K972445.
FLOWABLE COMPOSITE
K981965 · Dentsply Intl. · Jul 1998
ADHESIVE HYBRID IONOMER CEMENT
K974140 · Dentsply Intl. · Jan 1998
3M DENT SYSTEM II PLUS
K973961 · 3M Company · Dec 1997
3M VITREBOND LIGHT CURE GLASS IONOMER/BASE
K962065 · 3M Company · Jul 1996
NEW LUTING CEMENT MATERIAL (NLC)
K940914 · Dentsply Intl. · Aug 1994
MULTIPURPOSE RESIN CEMENT WITH FLUORIDE (MRCF)
K940459 · Dentsply Intl. · Apr 1994