Cleared Traditional

K994180 - PULPDENT CAVITY PREPARATION III

K994180 is the FDA 510(k) clearance for PULPDENT CAVITY PREPARATION III by Pulpdent Corp.. It is a Class 2 Dental device (product code LBH) cleared through the Traditional 510(k) pathway after a 83-day FDA review.

K994180 · Pulpdent Corp. · Dental device
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Mar 2000
Decision
83d
Days
Class 2
Risk

K994180 is an FDA 510(k) clearance for the PULPDENT CAVITY PREPARATION III. Classified as Varnish, Cavity (product code LBH), Class II - Special Controls.

Submitted by Pulpdent Corp. (Watertown, US). The FDA issued a Cleared decision on March 2, 2000 after a review of 83 days - a notably fast clearance cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3260 - 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 Pulpdent Corp. devices

Submission Details

510(k) Number K994180 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 10, 1999
Decision Date March 02, 2000
Days to Decision 83 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
44d faster than avg
Panel avg: 127d · This submission: 83d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code LBH Varnish, Cavity
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.3260
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 - LBH Varnish, Cavity

All 78
Devices cleared under the same product code (LBH) and FDA review panel - the closest regulatory comparables to K994180.
SEAL & PROTECT PROTECTIVE SEALANT
K021805 · Dentsply Intl. · Aug 2002
PULPDENT CAVITY PREPARATION IV
K013411 · Pulpdent Corp. · Dec 2001
QUELL DESENSITIZER
K010957 · Jeneric/Pentron, Inc. · Jun 2001
PULPDENT CAVITY PREPARATION II, PULPDENT CAVITY PREPARATION II WUTH FLUORIDE
K994181 · Pulpdent Corp. · Feb 2000
PULPDENT CAVITY PREPARATION 1, PULPDENT CAVITY PREPARATION 1 WITH FLUORIDE
K994182 · Pulpdent Corp. · Feb 2000
SEAL & PROTECT PROTECTIVE SEALANT FOR EXPOSED DENTINE
K992822 · Dentsply Intl. · Nov 1999