Cleared Traditional

K943372 - CALCIUM HYDROXIDE PASTE

K943372 is the FDA 510(k) clearance for CALCIUM HYDROXIDE PASTE by Ultradent Products, Inc.. It is a Class 2 Dental device (product code EJK) cleared through the Traditional 510(k) pathway after a 68-day FDA review.

K943372 · Ultradent Products, Inc. · Dental device
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Sep 1994
Decision
68d
Days
Class 2
Risk

K943372 is an FDA 510(k) clearance for the CALCIUM HYDROXIDE PASTE. Classified as Liner, Cavity, Calcium Hydroxide (product code EJK), Class II - Special Controls.

Submitted by Ultradent Products, Inc. (South Jordan, US). The FDA issued a Cleared decision on September 19, 1994 after a review of 68 days - a notably fast clearance cycle.

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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Ultradent Products, Inc. devices

Submission Details

510(k) Number K943372 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 13, 1994
Decision Date September 19, 1994
Days to Decision 68 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
59d faster than avg
Panel avg: 127d · This submission: 68d
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 41
Devices cleared under the same product code (EJK) and FDA review panel - the closest regulatory comparables to K943372.
LIMELIGHT
K953079 · Pulpdent Corp. · Aug 1995
PULPDENT CALCIUM HYDROXIDE PREPARATIONS
K944945 · Pulpdent Corp. · Nov 1994
LIFE
K944416 · Sybron Dental Specialties, Inc. · Nov 1994
NEEDLETUBE SYRINGE CARTRTIDGE
K933507 · Centrix, Inc. · Jan 1994
STERIBASE (ACCUBASE)
K933999 · Centrix, Inc. · Jan 1994
VIVAGLASS LINER
K931502 · Ivoclar North America, Inc. · Jul 1993