Cleared Traditional

K945244 - PULP CANAL SEALER EWT

K945244 is the FDA 510(k) clearance for PULP CANAL SEALER EWT by Sybron Dental Specialties, Inc.. It is a Class 2 Dental device (product code EMA) cleared through the Traditional 510(k) pathway after a 63-day FDA review.

K945244 · Sybron Dental Specialties, Inc. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 1994
Decision
63d
Days
Class 2
Risk

K945244 is an FDA 510(k) clearance for the PULP CANAL SEALER EWT. Classified as Cement, Dental (product code EMA), Class II - Special Controls.

Submitted by Sybron Dental Specialties, Inc. (Glendora, US). The FDA issued a Cleared decision on December 29, 1994 after a review of 63 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 Sybron Dental Specialties, Inc. devices

Submission Details

510(k) Number K945244 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 27, 1994
Decision Date December 29, 1994
Days to Decision 63 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
64d faster than avg
Panel avg: 127d · This submission: 63d
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 233
Devices cleared under the same product code (EMA) and FDA review panel - the closest regulatory comparables to K945244.
PROVILINK
K950060 · Ivoclar North America, Inc. · Feb 1995
PULPDENT PERIODONTAL DRESSINGS
K946137 · Pulpdent Corp. · Jan 1995
FUJI DUET
K946100 · GC America, Inc. · Jan 1995
SEALAPEX
K944480 · Sybron Dental Specialties, Inc. · Nov 1994
NEW LUTING CEMENT MATERIAL (NLC)
K940914 · Dentsply Intl. · Aug 1994
DEOX, OXYGEN BARRIER VISCOUS SOLUTION
K941065 · Ultradent Products, Inc. · Jun 1994