Cleared Traditional

K895988 - POTASSIUM NITRATE-ZINC OXIDE EUGENOL TEMP. DENTAL

K895988 is an FDA 510(k) clearance for POTASSIUM NITRATE-ZINC OXIDE EUGENOL TE..., 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 146-day FDA review.

K895988 · Milton Hodosh, M.D. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 1990
Decision
146d
Days
Class 2
Risk

K895988 is an FDA 510(k) clearance for the POTASSIUM NITRATE-ZINC OXIDE EUGENOL TEMP. DENTAL. 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 March 7, 1990 after a review of 146 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 Milton Hodosh, M.D. devices

FDA 510(k) Submission Details - K895988

510(k) Number K895988 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 12, 1989
Decision Date March 07, 1990
Days to Decision 146 days
Submission Type Traditional
Review Panel Dental (DE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
19d slower than avg
Panel avg: 127d · This submission: 146d
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 K895988.
GLASION
K895386 · Scientific Pharmaceuticals, Inc. · Apr 1990
TEMPORARY DENTAL CEMENT
K895487 · Dentsply Intl. · Apr 1990
KETAC-CEM MAXICAP
K897188 · Espe GmbH (Us) · Mar 1990
GRANITEC Z2, ZINC PHOSPHATE CEMENT
K896649 · Confi-Dental Products Co. · Feb 1990
GRANITEC P2 AND GRANITEC G2 DENTAL CEMENTS
K894953 · Confi-Dental Products Co. · Feb 1990
BANDTITE GLASS IONOMER CEMENT
K896249 · American Orthodontics · Jan 1990