Cleared Traditional

BARITONE C2 & BARITONE L3 (K914322) - FDA 510(k) Clearance

Class II Dental device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K914322 · Confi-Dental Products Co. · Dental device
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Oct 1991
Decision
27d
Days
Class 2
Risk

K914322 is an FDA 510(k) clearance for the BARITONE C2 & BARITONE L3. 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 October 23, 1991 after a review of 27 days - a notably fast clearance cycle.

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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Confi-Dental Products Co. devices

Submission Details

510(k) Number K914322 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 26, 1991
Decision Date October 23, 1991
Days to Decision 27 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
100d faster than avg
Panel avg: 127d · This submission: 27d
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 25
Devices cleared under the same product code (EBC) and FDA review panel - the closest regulatory comparables to K914322.
DELTON FS WITH FLUORIDE PIT & FISSURE SEALANT
K991909 · Dentsply Intl. · Aug 1999
DELTON FS DIRECT DELIVERY SYSTEM
K982564 · Dentsply Intl. · Oct 1998
DELTON F PIT & FISSURE SEALANT
K951296 · Dentsply Intl. · May 1995
FLUROSHIELD(TM) VISIBLE LIGHT CURE PIT & FISSURE
K896341 · Dentsply Intl. · Apr 1990
MODIFIED PRISMA SHIELD PIT & FISSURE SEALANT
K874944 · Dentsply Intl. · Feb 1988
PRISMA METAL OPAQUERS
K862660 · Dentsply Intl. · Jul 1986