Cleared Traditional

K882417 - POTASSIUM NITRATE POLYCARBOXYLATE DENTAL CEMENT

K882417 is an FDA 510(k) clearance for POTASSIUM NITRATE POLYCARBOXYLATE DENTA..., manufactured by Milton Hodosh, M.D.. The device is a Class 2 Dental device with product code EMA cleared through the Traditional 510(k) pathway after a 245-day FDA review.

K882417 · Milton Hodosh, M.D. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 1989
Decision
245d
Days
Class 2
Risk

K882417 is an FDA 510(k) clearance for the POTASSIUM NITRATE POLYCARBOXYLATE DENTAL CEMENT. Classified as Cement, Dental (product code EMA), Class II - Special Controls.

Submitted by Milton Hodosh, M.D. (Providence, US). The FDA issued a Cleared decision on February 13, 1989 after a review of 245 days - an extended review cycle.

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 Milton Hodosh, M.D. devices

FDA 510(k) Submission Details - K882417

510(k) Number K882417 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 13, 1988
Decision Date February 13, 1989
Days to Decision 245 days
Submission Type Traditional
Review Panel Dental (DE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
118d slower than avg
Panel avg: 127d · This submission: 245d
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 412
Devices cleared under the same product code (EMA) and FDA review panel - the closest regulatory comparables to K882417.
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
RESUBMITTED EMA DENTIN CEMENT
K883770 · G-C Intl. Corp. · Nov 1988