Cleared Traditional

K945451 - HI DENSE

K945451 is the FDA 510(k) clearance for HI DENSE by Shofu Dental Corp.. It is a Class 2 Dental device (product code EMA) cleared through the Traditional 510(k) pathway after a 112-day FDA review.

K945451 · Shofu Dental Corp. · Dental device
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Feb 1995
Decision
112d
Days
Class 2
Risk

K945451 is an FDA 510(k) clearance for the HI DENSE, GLASS IONOMER SILVER REINFORCED RESTORATIVE. Classified as Cement, Dental (product code EMA), Class II - Special Controls.

Submitted by Shofu Dental Corp. (Menlo Park, US). The FDA issued a Cleared decision on February 27, 1995 after a review of 112 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Dental review framework, consistent with the majority of Class II 510(k) submissions.

View all Shofu Dental Corp. devices

Submission Details

510(k) Number K945451 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 07, 1994
Decision Date February 27, 1995
Days to Decision 112 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
15d faster than avg
Panel avg: 127d · This submission: 112d
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 219
Devices cleared under the same product code (EMA) and FDA review panel - the closest regulatory comparables to K945451.
PULPDENT POST CEMENT
K952960 · Pulpdent Corp. · Jul 1995
PULPDENT GLASS IONOMER CEMENTS
K951270 · Pulpdent Corp. · May 1995
FUJI IX
K951555 · GC America, Inc. · May 1995
VIVAGLASS BASE
K950428 · Ivoclar North America, Inc. · Feb 1995
PROVILINK
K950060 · Ivoclar North America, Inc. · Feb 1995
PULPDENT PERIODONTAL DRESSINGS
K946137 · Pulpdent Corp. · Jan 1995