Cleared Traditional

K002461 - HY-BOND POLYCARBOXYLATE TEMPORARY DENTA...

K002461 is the FDA 510(k) clearance for HY-BOND POLYCARBOXYLATE TEMPORARY DENTA... by Shofu Dental Corp.. It is a Class 2 Dental device (product code EMA) cleared through the Traditional 510(k) pathway after a 47-day FDA review.

K002461 · Shofu Dental Corp. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 2000
Decision
47d
Days
Class 2
Risk

K002461 is an FDA 510(k) clearance for the HY-BOND POLYCARBOXYLATE TEMPORARY DENTAL CEMENT. 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 September 26, 2000 after a review of 47 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 Shofu Dental Corp. devices

Submission Details

510(k) Number K002461 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 10, 2000
Decision Date September 26, 2000
Days to Decision 47 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
80d faster than avg
Panel avg: 127d · This submission: 47d
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 K002461.
DYRACT CEM LCI COMPOMER
K003921 · Dentsply Intl. · Jan 2001
TEMP-BOND NE 2
K003658 · Sybron Dental Specialties, Inc. · Jan 2001
3M RELY X VENEER CEMENT TRY-IN PASTER
K002452 · 3M Company · Sep 2000
LINKMAX
K001823 · GC America, Inc. · Aug 2000
GC FUJICEM
K001730 · GC America, Inc. · Jul 2000
CEMENT IT! UNIVERSAL C&B
K000173 · Jeneric/Pentron, Inc. · Feb 2000