Cleared Traditional

K962383 - PULPDENT RESILUTE II

K962383 is the FDA 510(k) clearance for PULPDENT RESILUTE II by Pulpdent Corp.. It is a Class 2 Dental device (product code EMA) cleared through the Traditional 510(k) pathway after a 75-day FDA review.

K962383 · Pulpdent Corp. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 1996
Decision
75d
Days
Class 2
Risk

K962383 is an FDA 510(k) clearance for the PULPDENT RESILUTE II. Classified as Cement, Dental (product code EMA), Class II - Special Controls.

Submitted by Pulpdent Corp. (Watertown, US). The FDA issued a Cleared decision on September 3, 1996 after a review of 75 days - a notably fast clearance cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3275 - 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 Pulpdent Corp. devices

Submission Details

510(k) Number K962383 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 20, 1996
Decision Date September 03, 1996
Days to Decision 75 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
52d faster than avg
Panel avg: 127d · This submission: 75d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code EMA Cement, Dental
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.3275
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 - EMA Cement, Dental

All 284
Devices cleared under the same product code (EMA) and FDA review panel - the closest regulatory comparables to K962383.
SPETEMP EF
K964809 · Ultradent Products, Inc. · Jan 1997
PULPDENT ENDODONTIC POST CEMENT KIT
K962747 · Pulpdent Corp. · Sep 1996
STERI-OSS TEMPORARY IMPLANT CEMENT
K963078 · Steri-Oss, Inc. · Sep 1996
3M VITREBOND LIGHT CURE GLASS IONOMER/BASE
K962065 · 3M Company · Jul 1996
FUJI IX GP
K961448 · GC America, Inc. · Jul 1996
VIVAGLASS FIL
K961910 · Ivoclar North America, Inc. · Jun 1996