Cleared Traditional

K112597 - SEITY 37% PHOSPHORIC ACID ETCHANT GEL

K112597 is an FDA 510(k) clearance for SEITY 37% PHOSPHORIC ACID ETCHANT GEL, manufactured by Mycone Dental Supply Co., Inc.. The device is a Class 2 Dental device with product code KLE cleared through the Traditional 510(k) pathway after a 91-day FDA review.

K112597 · Mycone Dental Supply Co., Inc. · Dental device
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Dec 2011
Decision
91d
Days
Class 2
Risk

K112597 is an FDA 510(k) clearance for the SEITY 37% PHOSPHORIC ACID ETCHANT GEL. Classified as Agent, Tooth Bonding, Resin (product code KLE), Class II - Special Controls.

Submitted by Mycone Dental Supply Co., Inc. (Cherry Hill, US). The FDA issued a Cleared decision on December 7, 2011 after a review of 91 days - within the typical 510(k) review window.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3200 - 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 Mycone Dental Supply Co., Inc. devices

FDA 510(k) Submission Details - K112597

510(k) Number K112597 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 07, 2011
Decision Date December 07, 2011
Days to Decision 91 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
36d faster than avg
Panel avg: 127d · This submission: 91d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KLE Device Classification - Class 2, Special Controls

Product Code KLE Agent, Tooth Bonding, Resin
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.3200
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 - KLE Agent, Tooth Bonding, Resin

All 344
Devices cleared under the same product code (KLE) and FDA review panel - the closest regulatory comparables to K112597.
CERARESIN BOND
K123119 · Shofu Dental Corporation · Nov 2012
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K120767 · Spident Co., Ltd. · May 2012
ETCH-RITE SUPREME
K120213 · Pulpdent Corporation · Mar 2012
DREAMBOND
K112118 · Bisco, Inc. · Nov 2011
CLEARFIL TRI-S BOND PLUS SINGLE DOSE STANDARD / VALUE / INTRODUCTORY PACK
K111975 · Kuraray Medical, Inc. · Oct 2011
BEAUTIBOND MULTI
K110235 · Shofu Dental Corp. · May 2011