Cleared Traditional

K953272 - PULPDENT DENTASTIC II

K953272 is the FDA 510(k) clearance for PULPDENT DENTASTIC II by Pulpdent Corp.. It is a Class 2 Dental device (product code EMA) cleared through the Traditional 510(k) pathway after a 43-day FDA review.

K953272 · Pulpdent Corp. · Dental device

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Aug 1995

Decision

43d

Days

Class 2

Risk

K953272 is an FDA 510(k) clearance for the PULPDENT DENTASTIC 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 August 25, 1995 after a review of 43 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	K953272 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	July 13, 1995
Decision Date	August 25, 1995
Days to Decision	43 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

84d faster than avg

Panel avg: 127d · This submission: 43d

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 K953272.

PULPDENT RESILUTE

K955017 · Pulpdent Corp. · Dec 1995

NEXUS

K954762 · Sybron Dental Specialties, Inc. · Nov 1995

TRY-IN GEL

K954643 · Sybron Dental Specialties, Inc. · Oct 1995

DENTASTIC ONE-STEP

K953301 · Pulpdent Corp. · Aug 1995

PULPDENT POST CEMENT

K952960 · Pulpdent Corp. · Jul 1995

PULPDENT GLASS IONOMER CEMENTS

K951270 · Pulpdent Corp. · May 1995

Related FDA 510(k) Regulatory Insights

Additional regulatory intelligence related to this FDA 510(k) submission, including predicate strategy, review pathways and device classification guidance.

Manufacturer of K953272

Pulpdent Corp.

Watertown, MA · US

KENNETH J BERK

Regulatory profile

78 submissions 78 cleared

100% clearance rate · Active in Dental

Data Intelligence Layer

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