Cleared Traditional

MODIFICATION TO POTASSIUM NITRATE-POLYCARBOXYLATE DENTAL CEMENT (K022025) - FDA 510(k) Clearance

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

K022025 · Milton Hodosh, M.D. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2002
Decision
56d
Days
Class 2
Risk

K022025 is an FDA 510(k) clearance for the MODIFICATION TO POTASSIUM NITRATE-POLYCARBOXYLATE DENTAL CEMENT. Classified as Liner, Cavity, Calcium Hydroxide (product code EJK), Class II - Special Controls.

Submitted by Milton Hodosh, M.D. (Providence, US). The FDA issued a Cleared decision on August 15, 2002 after a review of 56 days - a notably fast clearance cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3250 - 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 Milton Hodosh, M.D. devices

Submission Details

510(k) Number K022025 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 20, 2002
Decision Date August 15, 2002
Days to Decision 56 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
71d faster than avg
Panel avg: 127d · This submission: 56d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code EJK Liner, Cavity, Calcium Hydroxide
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.3250
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 - EJK Liner, Cavity, Calcium Hydroxide

All 12
Devices cleared under the same product code (EJK) and FDA review panel - the closest regulatory comparables to K022025.
LC ResinCal PC
K202413 · S&C Polymer Silicon- Und Composite Spezialitaten GmbH · Nov 2020
Parkell Desensitizer Gel
K191103 · Parkell, Inc. · Nov 2019
TheraCal DC
K180344 · Bisco, Inc. · Apr 2018
VLC DYCAL II
K922721 · Dentsply Intl. · Jul 1992
VLC GLASS IONOMER LINER
K911244 · Dentsply Intl. · Jun 1991
GLASS IONOMER BASE
K882751 · Dentsply Intl. · Nov 1988