Cleared Traditional

K972445 - PULPDENT OX-OUT

K972445 is the FDA 510(k) clearance for PULPDENT OX-OUT by Pulpdent Corp.. It is a Class 2 Dental device (product code EMA) cleared through the Traditional 510(k) pathway after a 94-day FDA review.

K972445 · Pulpdent Corp. · Dental device
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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
Combination Product No
PCCP Authorized No
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 284
Devices cleared under the same product code (EMA) and FDA review panel - the closest regulatory comparables to K972445.
PULPDENT DENTASTIC UNO
K974014 · Pulpdent Corp. · Dec 1997
SYNTAC SPRINT
K973397 · Ivoclar North America, Inc. · Nov 1997
STERI-OSS UNTIL IMPLANT CEMENT
K972965 · Steri-Oss, Inc. · Nov 1997
HI DENSE TC
K971927 · Shofu Dental Corp. · Jun 1997
SPETEMP
K964808 · Ultradent Products, Inc. · Feb 1997
SPETEMP EF
K964809 · Ultradent Products, Inc. · Jan 1997