Cleared Traditional

K940122 - HY BOND

K940122 is the FDA 510(k) clearance for HY BOND 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.

K940122 · Shofu Dental Corp. · Dental device
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May 1994
Decision
112d
Days
Class 2
Risk

K940122 is an FDA 510(k) clearance for the HY BOND, GLASIONOMER CX. 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 May 2, 1994 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 K940122 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 10, 1994
Decision Date May 02, 1994
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 K940122.
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
MULTIPURPOSE RESIN CEMENT WITH FLUORIDE (MRCF)
K940459 · Dentsply Intl. · Apr 1994
BISCO COMPOSITE
K940030 · Bisco, Inc. · Feb 1994
GC ELITE CEMENT
K935521 · GC America, Inc. · Jan 1994