Cleared Traditional

K022025 - MODIFICATION TO POTASSIUM NITRATE-POLYCARBOXYLATE DENTAL CEMENT

K022025 is an FDA 510(k) clearance for MODIFICATION TO POTASSIUM NITRATE-POLYC..., manufactured by Milton Hodosh, M.D.. The device is a Class 2 Dental device with product code EJK cleared through the Traditional 510(k) pathway after a 56-day FDA review.

K022025 · Milton Hodosh, M.D. · Dental device
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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.

FDA 510(k) Submission Details - K022025

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
72d faster than avg
Panel avg: 128d · This submission: 56d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

EJK Device Classification - Class 2, Special Controls

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 76
Devices cleared under the same product code (EJK) and FDA review panel - the closest regulatory comparables to K022025.
THERACAL LC
K063237 · Bisco, Inc. · Dec 2006
APEXCAL
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BISBLOCK
K033521 · Bisco, Inc. · Jan 2004
D/SENSE 1-STEP
K021146 · Centrix, Inc. · Jul 2002
LIFE 2
K012717 · Sybron Dental Specialties, Inc. · Oct 2001
CALEX CONDITIONER
K010176 · Stephen M Koral, Dmd · Mar 2001
K022025 · MODIFICATION TO POTASSIUM NITRATE-POLYCARBOXYLATE DENTAL CEMENT
Download PDF Milton Hodosh, M.D.