Cleared Traditional

K913853 - FISSURE SEALER

K913853 is an FDA 510(k) clearance for FISSURE SEALER, manufactured by Ortho Source. The device is a Class 2 Dental device with product code EBC cleared through the Traditional 510(k) pathway after a 366-day FDA review.

K913853 · Ortho Source · Dental device
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Aug 1992
Decision
366d
Days
Class 2
Risk

K913853 is an FDA 510(k) clearance for the FISSURE SEALER. Classified as Sealant, Pit And Fissure, And Conditioner (product code EBC), Class II - Special Controls.

Submitted by Ortho Source (North Hollywood, US). The FDA issued a Cleared decision on August 27, 1992 after a review of 366 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 Ortho Source devices

FDA 510(k) Submission Details - K913853

510(k) Number K913853 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 27, 1991
Decision Date August 27, 1992
Days to Decision 366 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
239d slower than avg
Panel avg: 127d · This submission: 366d
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 109
Devices cleared under the same product code (EBC) and FDA review panel - the closest regulatory comparables to K913853.
ALPHA-DENT PIT AND FISSURE SEALANT
K924635 · Wallace A. Erickson & Co. · Oct 1992
ULTRADENT PRODUCT DENTIN CONDITION & SEAL PROD LIN
K921599 · Ultradent Products, Inc. · Sep 1992
ULTRADENT PROD LI CURED PIT/FISSURE SEAL PROD LINE
K921600 · Ultradent Products, Inc. · Sep 1992
ESTISEAL LC
K915095 · Heraeus Kulzer, Inc. · Jan 1992
PIT AND FISSURE SEALANT PRODUCTS
K914319 · Confi-Dental Products Co. · Oct 1991
BARITONE C2 & BARITONE L3
K914322 · Confi-Dental Products Co. · Oct 1991