Cleared Traditional

K964191 - CALCIUM HYDROXIDE MEDICAMENT

K964191 is an FDA 510(k) clearance for CALCIUM HYDROXIDE MEDICAMENT, manufactured by Sybron Dental Specialties, Inc.. The device is a Class 2 Dental device with 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

FDA 510(k) Submission Details - K964191

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.

EJK Device Classification - Class 2, Special Controls

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 58
Devices cleared under the same product code (EJK) and FDA review panel - the closest regulatory comparables to K964191.
ROEKO CALCIUM HYDROXIDE POINTS
K973539 · Roeko USA, Inc. · Oct 1997
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