Cleared Traditional

K905582 - POTASSIUM NITRATE COMPOSITE RESTORATION PIT AND

K905582 is an FDA 510(k) clearance for POTASSIUM NITRATE COMPOSITE RESTORATION..., manufactured by Milton Hodosh, M.D.. The device is a Class 2 Dental device with product code EBC cleared through the Traditional 510(k) pathway after a 138-day FDA review.

K905582 · Milton Hodosh, M.D. · Dental device
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Apr 1991
Decision
138d
Days
Class 2
Risk

K905582 is an FDA 510(k) clearance for the POTASSIUM NITRATE COMPOSITE RESTORATION PIT AND. Classified as Sealant, Pit And Fissure, And Conditioner (product code EBC), Class II - Special Controls.

Submitted by Milton Hodosh, M.D. (Providence, US). The FDA issued a Cleared decision on April 29, 1991 after a review of 138 days - within the typical 510(k) review window.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3765 - 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 - K905582

510(k) Number K905582 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 12, 1990
Decision Date April 29, 1991
Days to Decision 138 days
Submission Type Traditional
Review Panel Dental (DE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
11d slower than avg
Panel avg: 127d · This submission: 138d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

EBC Device Classification - Class 2, Special Controls

Product Code EBC Sealant, Pit And Fissure, And Conditioner
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.3765
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 - EBC Sealant, Pit And Fissure, And Conditioner

All 104
Devices cleared under the same product code (EBC) and FDA review panel - the closest regulatory comparables to K905582.
PIT AND FISSURE SEALANT PRODUCTS
K914319 · Confi-Dental Products Co. · Oct 1991
BARITONE C2 & BARITONE L3
K914322 · Confi-Dental Products Co. · Oct 1991
PULPDENT SEAL RITE
K911287 · Pulpdent Corp. · Jun 1991
DEGUFILL (TM) WHIT-SEALANT
K902742 · Degussa AG · Sep 1990
SEAL RITE(TM)
K902022 · Pulpdent Corp. · Jul 1990
SEAL RITE PROCEDURE KIT(TM)
K902023 · Pulpdent Corp. · Jul 1990