Cleared Traditional

K965091 - TEETHMATE F-1

K965091 is an FDA 510(k) clearance for TEETHMATE F-1, manufactured by Kuraray Company, Ltd.. The device is a Class 2 Dental device with product code EBC cleared through the Traditional 510(k) pathway after a 98-day FDA review.

K965091 · Kuraray Company, Ltd. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 1997
Decision
98d
Days
Class 2
Risk

K965091 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 Company, Ltd. (New York, US). The FDA issued a Cleared decision on March 27, 1997 after a review of 98 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Dental review framework, consistent with the majority of Class II 510(k) submissions.

View all Kuraray Company, Ltd. devices

FDA 510(k) Submission Details - K965091

510(k) Number K965091 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 19, 1996
Decision Date March 27, 1997
Days to Decision 98 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
29d faster than avg
Panel avg: 127d · This submission: 98d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

EBC Device Classification - Class 2, Special Controls

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 96
Devices cleared under the same product code (EBC) and FDA review panel - the closest regulatory comparables to K965091.
CONSEAL F
K990650 · Southern Dental Industries, Inc. · May 1999
DELTON FS DIRECT DELIVERY SYSTEM
K982564 · Dentsply Intl. · Oct 1998
MEDENTAL CHEMICAL CURING SEALANT PIT & FISSURE TINTED
K973541 · Medental Intl. · Nov 1997
PULPDENT SEAL-RITE UDMA
K963921 · Pulpdent Corp. · Nov 1996
GLY-ETCH
K961190 · Centrix, Inc. · Apr 1996
SEALITE FL
K954827 · Sybron Dental Specialties, Inc. · Jan 1996