Cleared Traditional

TEETHMATE-F (K910424) - FDA 510(k) Clearance

Class II Dental device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K910424 · Kuraray Co. · Dental device
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Apr 1991
Decision
63d
Days
Class 2
Risk

K910424 is an FDA 510(k) clearance for the TEETHMATE-F. Classified as Cement, Dental (product code EMA), Class II - Special Controls.

Submitted by Kuraray Co. (New York, US). The FDA issued a Cleared decision on April 3, 1991 after a review of 63 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 Kuraray Co. devices

Submission Details

510(k) Number K910424 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 30, 1991
Decision Date April 03, 1991
Days to Decision 63 days
Submission Type Traditional
Review Panel Dental (DE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
64d faster than avg
Panel avg: 127d · This submission: 63d
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 80
Devices cleared under the same product code (EMA) and FDA review panel - the closest regulatory comparables to K910424.
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CHEMFIL II CAPS
K901524 · Dentsply Intl. · Sep 1990
3M LUTING CEMENT - PASTE A AND PASTE B
K902041 · 3M Company · Jun 1990
BIOMER(R) F COMPOSITE LUTING CEMENT
K896340 · Dentsply Intl. · May 1990