Cleared Traditional

K862280 - SHOFU LINING CEMENT

K862280 is the FDA 510(k) clearance for SHOFU LINING CEMENT by Shofu Dental Corp.. It is a Class 2 Dental device (product code EMA) cleared through the Traditional 510(k) pathway after a 7-day FDA review.

K862280 · Shofu Dental Corp. · Dental device
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Jun 1986
Decision
7d
Days
Class 2
Risk

K862280 is an FDA 510(k) clearance for the SHOFU LINING 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 June 23, 1986 after a review of 7 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 K862280 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 16, 1986
Decision Date June 23, 1986
Days to Decision 7 days
Submission Type Traditional
Review Panel Dental (DE)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
120d faster than avg
Panel avg: 127d · This submission: 7d
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 K862280.
MODI. DICOR CASTABLE CERAMIC/ALL PORCELAIN BRIDGES
K864725 · Dentsply Intl. · Jan 1987
3M GLASS IONOMER LINER
K864270 · 3M Company · Dec 1986
KULZER GLASS IONOMER LINER
K863141 · Shofu Dental Corp. · Aug 1986
GLASIONOMER BASE CEMENT
K861005 · Shofu Dental Corp. · Apr 1986
GLAS IONOMER CEMENT
K850913 · Shofu Dental Corp. · Apr 1985
ESPE KETAC-CEM RADIOPAQUE
K844846 · Espe GmbH (Us) · Mar 1985