Cleared Traditional

DENTASTIC ONE-STEP (K953301) - FDA 510(k) Clearance

Class II Dental device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K953301 · Pulpdent Corp. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 1995
Decision
42d
Days
Class 2
Risk

K953301 is an FDA 510(k) clearance for the DENTASTIC ONE-STEP. 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 42 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 K953301 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 14, 1995
Decision Date August 25, 1995
Days to Decision 42 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
85d faster than avg
Panel avg: 127d · This submission: 42d
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 80
Devices cleared under the same product code (EMA) and FDA review panel - the closest regulatory comparables to K953301.
ADHESIVE HYBRID IONOMER CEMENT
K974140 · Dentsply Intl. · Jan 1998
3M DENT SYSTEM II PLUS
K973961 · 3M Company · Dec 1997
3M VITREBOND LIGHT CURE GLASS IONOMER/BASE
K962065 · 3M Company · Jul 1996
NEW LUTING CEMENT MATERIAL (NLC)
K940914 · Dentsply Intl. · Aug 1994
MULTIPURPOSE RESIN CEMENT WITH FLUORIDE (MRCF)
K940459 · Dentsply Intl. · Apr 1994
3M VITREMER LUTING CEMENT
K933139 · 3M Company · Jan 1994