Cleared Traditional

K012742 - TEETHMATE F-1

K012742 is the FDA 510(k) clearance for TEETHMATE F-1 by Kuraray Medical, Inc.. It is a Class 2 Dental device (product code EBC) cleared through the Traditional 510(k) pathway after a 31-day FDA review.

K012742 · Kuraray Medical, Inc. · Dental device
Download Printable Device Report (PDF)
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Sep 2001
Decision
31d
Days
Class 2
Risk

K012742 is an FDA 510(k) clearance for the TEETHMATE F-1. Classified as Sealant, Pit And Fissure, And Conditioner (product code EBC), Class II - Special Controls.

Submitted by Kuraray Medical, Inc. (New York, US). The FDA issued a Cleared decision on September 14, 2001 after a review of 31 days - a notably fast clearance cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3765 - 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 Medical, Inc. devices

Submission Details

510(k) Number K012742 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 14, 2001
Decision Date September 14, 2001
Days to Decision 31 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
96d faster than avg
Panel avg: 127d · This submission: 31d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code EBC Sealant, Pit And Fissure, And Conditioner
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.3765
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 - EBC Sealant, Pit And Fissure, And Conditioner

All 62
Devices cleared under the same product code (EBC) and FDA review panel - the closest regulatory comparables to K012742.
ADMIRA SEAL
K021842 · Voco GmbH · Jul 2002
ADMIRA PROTECT
K021844 · Voco GmbH · Jul 2002
REVOTEK LC
K012542 · GC America, Inc. · Oct 2001
HELIOSEAL CLEAR CHROMA
K011491 · Ivoclar North America, Inc. · Aug 2001
ULTRASEAL XT PLUS
K993846 · Ultradent Products, Inc. · Feb 2000
NRC NON-RINSE CONDITIONER
K992519 · Dentsply Intl. · Oct 1999