Cleared Traditional

K964191 - CALCIUM HYDROXIDE MEDICAMENT

K964191 is the FDA 510(k) clearance for CALCIUM HYDROXIDE MEDICAMENT by Sybron Dental Specialties, Inc.. It is a Class 2 Dental device (product code EJK) cleared through the Traditional 510(k) pathway after a 93-day FDA review.

K964191 · Sybron Dental Specialties, Inc. · Dental device
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Jan 1997
Decision
93d
Days
Class 2
Risk

K964191 is an FDA 510(k) clearance for the CALCIUM HYDROXIDE MEDICAMENT. Classified as Liner, Cavity, Calcium Hydroxide (product code EJK), Class II - Special Controls.

Submitted by Sybron Dental Specialties, Inc. (Orange, US). The FDA issued a Cleared decision on January 22, 1997 after a review of 93 days - within the typical 510(k) review window.

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: 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 Sybron Dental Specialties, Inc. devices

Submission Details

510(k) Number K964191 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 21, 1996
Decision Date January 22, 1997
Days to Decision 93 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
34d faster than avg
Panel avg: 127d · This submission: 93d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 40
Devices cleared under the same product code (EJK) and FDA review panel - the closest regulatory comparables to K964191.
CALCIJECT
K001050 · Centrix, Inc. · Jul 2000
ULTRA-BLEND PLUS
K970113 · Ultradent Products, Inc. · Apr 1997
ULTRACAL XS
K970114 · Ultradent Products, Inc. · Mar 1997
LIFE AND LIFE FAST SET
K961708 · Sybron Dental Specialties, Inc. · May 1996
ULTRA-BLEND
K953524 · Ultradent Products, Inc. · Aug 1995
LIMELIGHT
K953079 · Pulpdent Corp. · Aug 1995