Cleared Traditional

K811013 - SUMMAR NON-PRECIOUS

K811013 is the FDA 510(k) clearance for SUMMAR NON-PRECIOUS by Shofu Dental Corp.. It is a Class 2 Dental device (product code EJH) cleared through the Traditional 510(k) pathway after a 72-day FDA review.

K811013 · Shofu Dental Corp. · Dental device
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Jun 1981
Decision
72d
Days
Class 2
Risk

K811013 is an FDA 510(k) clearance for the SUMMAR NON-PRECIOUS, CERAMIC ALLOY. Classified as Alloy, Metal, Base (product code EJH), Class II - Special Controls.

Submitted by Shofu Dental Corp. (Mchenry, US). The FDA issued a Cleared decision on June 26, 1981 after a review of 72 days - a notably fast clearance cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3710 - 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 K811013 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 15, 1981
Decision Date June 26, 1981
Days to Decision 72 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
55d faster than avg
Panel avg: 127d · This submission: 72d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code EJH Alloy, Metal, Base
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.3710
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.