Cleared Traditional

K970114 - ULTRACAL XS

K970114 is the FDA 510(k) clearance for ULTRACAL XS by Ultradent Products, Inc.. It is a Class 2 Dental device (product code EJK) cleared through the Traditional 510(k) pathway after a 60-day FDA review.

K970114 · Ultradent Products, Inc. · Dental device
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Mar 1997
Decision
60d
Days
Class 2
Risk

K970114 is an FDA 510(k) clearance for the ULTRACAL XS. 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 March 14, 1997 after a review of 60 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 K970114 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 13, 1997
Decision Date March 14, 1997
Days to Decision 60 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
67d faster than avg
Panel avg: 127d · This submission: 60d
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 K970114.
LIFE 2
K012717 · Sybron Dental Specialties, Inc. · Oct 2001
CALCIJECT
K001050 · Centrix, Inc. · Jul 2000
ULTRA-BLEND PLUS
K970113 · Ultradent Products, Inc. · Apr 1997
CALCIUM HYDROXIDE MEDICAMENT
K964191 · Sybron Dental Specialties, Inc. · Jan 1997
LIFE AND LIFE FAST SET
K961708 · Sybron Dental Specialties, Inc. · May 1996
ULTRA-BLEND
K953524 · Ultradent Products, Inc. · Aug 1995