Cleared Traditional

K954867 - IONOSIT SEAL

K954867 is an FDA 510(k) clearance for IONOSIT SEAL, manufactured by Foremost Dental Mfg., Inc.. The device is a Class 2 Dental device with product code EBC cleared through the Traditional 510(k) pathway after a 136-day FDA review.

K954867 · Foremost Dental Mfg., Inc. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 1996
Decision
136d
Days
Class 2
Risk

K954867 is an FDA 510(k) clearance for the IONOSIT SEAL. Classified as Sealant, Pit And Fissure, And Conditioner (product code EBC), Class II - Special Controls.

Submitted by Foremost Dental Mfg., Inc. (Englewood, US). The FDA issued a Cleared decision on March 8, 1996 after a review of 136 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 Foremost Dental Mfg., Inc. devices

FDA 510(k) Submission Details - K954867

510(k) Number K954867 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 24, 1995
Decision Date March 08, 1996
Days to Decision 136 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
9d slower than avg
Panel avg: 127d · This submission: 136d
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 105
Devices cleared under the same product code (EBC) and FDA review panel - the closest regulatory comparables to K954867.
TEETHMATE F-1
K965091 · Kuraray Company, Ltd. · Mar 1997
PULPDENT SEAL-RITE UDMA
K963921 · Pulpdent Corp. · Nov 1996
GLY-ETCH
K961190 · Centrix, Inc. · Apr 1996
SEALITE FL
K954827 · Sybron Dental Specialties, Inc. · Jan 1996
AMERICAN DENTAL PRODUCTS PIT & FISSUE SEALANT LIGHT CURING
K954701 · American Dental Products, Inc. · Oct 1995
TOOTH PREPARATION CONDITIONER, PRE-IMPRESSION
K952240 · Jeneric/Pentron, Inc. · Aug 1995