Cleared Traditional

K931857 - SUPPLEMENTAL FORMULA TO BARITONE L3 SEA...

K931857 is the FDA 510(k) clearance for SUPPLEMENTAL FORMULA TO BARITONE L3 SEA... by Confi-Dental Products Co.. It is a Class 2 Dental device (product code EBC) cleared through the Traditional 510(k) pathway after a 100-day FDA review.

K931857 · Confi-Dental Products Co. · Dental device
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Jul 1993
Decision
100d
Days
Class 2
Risk

K931857 is an FDA 510(k) clearance for the SUPPLEMENTAL FORMULA TO BARITONE L3 SEALANT. Classified as Sealant, Pit And Fissure, And Conditioner (product code EBC), Class II - Special Controls.

Submitted by Confi-Dental Products Co. (Louisville, US). The FDA issued a Cleared decision on July 22, 1993 after a review of 100 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 Confi-Dental Products Co. devices

Submission Details

510(k) Number K931857 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 13, 1993
Decision Date July 22, 1993
Days to Decision 100 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
27d faster than avg
Panel avg: 127d · This submission: 100d
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 76
Devices cleared under the same product code (EBC) and FDA review panel - the closest regulatory comparables to K931857.
PULPDENT CHEMICAL CURE PIT AND FISSURE SEALANT
K945378 · Pulpdent Corp. · Jan 1995
PULPDENT SEAL-RITE LOW VISCOSITY
K932794 · Pulpdent Corp. · Sep 1993
HELIOSEAL F
K932078 · Ivoclar North America, Inc. · Sep 1993
PRIMADRY PRODUCT LINE
K931868 · Ultradent Products, Inc. · Jul 1993
ULTRASEAL XT PIT AND FISSURE SEALANT PRODUCT LINE
K931869 · Ultradent Products, Inc. · Jul 1993
BARITONE C2, MODIFICATION
K932002 · Confi-Dental Products Co. · Jul 1993