Cleared Traditional

K861005 - GLASIONOMER BASE CEMENT

K861005 is the FDA 510(k) clearance for GLASIONOMER BASE CEMENT by Shofu Dental Corp.. It is a Class 2 Dental device (product code EMA) cleared through the Traditional 510(k) pathway after a 38-day FDA review.

K861005 · Shofu Dental Corp. · Dental device
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Apr 1986
Decision
38d
Days
Class 2
Risk

K861005 is an FDA 510(k) clearance for the GLASIONOMER BASE 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 April 25, 1986 after a review of 38 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 K861005 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 18, 1986
Decision Date April 25, 1986
Days to Decision 38 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
89d faster than avg
Panel avg: 127d · This submission: 38d
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 K861005.
3M GLASS IONOMER LINER
K864270 · 3M Company · Dec 1986
KULZER GLASS IONOMER LINER
K863141 · Shofu Dental Corp. · Aug 1986
SHOFU LINING CEMENT
K862280 · Shofu Dental Corp. · Jun 1986
GLAS IONOMER CEMENT
K850913 · Shofu Dental Corp. · Apr 1985
ESPE KETAC-CEM RADIOPAQUE
K844846 · Espe GmbH (Us) · Mar 1985
KETAC-SILVER
K843566 · Espe GmbH (Us) · Dec 1984