Cleared Traditional

K940737 - EDTA GEL (TM)

K940737 is an FDA 510(k) clearance for EDTA GEL (TM), manufactured by Karolinska Institutet. The device is a Class 2 Dental device with product code EBF cleared through the Traditional 510(k) pathway after a 106-day FDA review.

K940737 · Karolinska Institutet · Dental device
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Jun 1994
Decision
106d
Days
Class 2
Risk

K940737 is an FDA 510(k) clearance for the EDTA GEL (TM). Classified as Material, Tooth Shade, Resin (product code EBF), Class II - Special Controls.

Submitted by Karolinska Institutet (Potomac, US). The FDA issued a Cleared decision on June 3, 1994 after a review of 106 days - within the typical 510(k) review window.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3690 - 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 Karolinska Institutet devices

FDA 510(k) Submission Details - K940737

510(k) Number K940737 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 17, 1994
Decision Date June 03, 1994
Days to Decision 106 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
21d faster than avg
Panel avg: 127d · This submission: 106d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

EBF Device Classification - Class 2, Special Controls

Product Code EBF Material, Tooth Shade, Resin
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.3690
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 - EBF Material, Tooth Shade, Resin

All 812
Devices cleared under the same product code (EBF) and FDA review panel - the closest regulatory comparables to K940737.
ALPHA-DENT C-R(R) HYBRID TYPE II COMPOSITE RESIN
K942767 · Wallace A. Erickson & Co. · Jul 1994
SDI COMPOSTIES
K941899 · Southern Dental Industries, Inc. · Jul 1994
CAULK TOOTH CONDITIONER GEL AND SYRINGE
K942031 · Dentsply Intl. · Jun 1994
PENT CORE PLUS (PASTE-PASTE)
K941373 · Jeneric/Pentron, Inc. · May 1994
CONQUEST SMOOTH TOUCH
K941377 · Jeneric/Pentron, Inc. · May 1994
CONQUEST PRELUDE
K941374 · Jeneric/Pentron, Inc. · May 1994