Cleared Traditional

K971927 - HI DENSE TC

K971927 is an FDA 510(k) clearance for HI DENSE TC, manufactured by Shofu Dental Corp.. The device is a Class 2 Dental device with product code EMA cleared through the Traditional 510(k) pathway after a 34-day FDA review.

K971927 · Shofu Dental Corp. · Dental device
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Jun 1997
Decision
34d
Days
Class 2
Risk

K971927 is an FDA 510(k) clearance for the HI DENSE TC. 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 30, 1997 after a review of 34 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

FDA 510(k) Submission Details - K971927

510(k) Number K971927 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 27, 1997
Decision Date June 30, 1997
Days to Decision 34 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
93d faster than avg
Panel avg: 127d · This submission: 34d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

EMA Device Classification - Class 2, Special Controls

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 396
Devices cleared under the same product code (EMA) and FDA review panel - the closest regulatory comparables to K971927.
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TEMPOCEM NE (MULTIPLE)
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SPETEMP
K964808 · Ultradent Products, Inc. · Feb 1997