Cleared Traditional

K945451 - HI DENSE, GLASS IONOMER SILVER REINFORCED RESTORATIVE

K945451 is an FDA 510(k) clearance for HI DENSE, manufactured by Shofu Dental Corp.. The device is a Class 2 Dental device with 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

FDA 510(k) Submission Details - K945451

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.

EMA Device Classification - Class 2, Special Controls

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 396
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
PARAPOST CEMENT
K945366 · Coltene/Whaledent, Inc. · Feb 1995