Cleared Traditional

K953524 - ULTRA-BLEND

K953524 is the FDA 510(k) clearance for ULTRA-BLEND by Ultradent Products, Inc.. It is a Class 2 Dental device (product code EJK) cleared through the Traditional 510(k) pathway after a 28-day FDA review.

K953524 · Ultradent Products, Inc. · Dental device
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Aug 1995
Decision
28d
Days
Class 2
Risk

K953524 is an FDA 510(k) clearance for the ULTRA-BLEND. 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 August 24, 1995 after a review of 28 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 K953524 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 27, 1995
Decision Date August 24, 1995
Days to Decision 28 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
99d faster than avg
Panel avg: 127d · This submission: 28d
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 K953524.
ULTRACAL XS
K970114 · Ultradent Products, Inc. · Mar 1997
CALCIUM HYDROXIDE MEDICAMENT
K964191 · Sybron Dental Specialties, Inc. · Jan 1997
LIFE AND LIFE FAST SET
K961708 · Sybron Dental Specialties, Inc. · May 1996
LIMELIGHT
K953079 · Pulpdent Corp. · Aug 1995
PULPDENT CALCIUM HYDROXIDE PREPARATIONS
K944945 · Pulpdent Corp. · Nov 1994
LIFE
K944416 · Sybron Dental Specialties, Inc. · Nov 1994