Cleared Traditional

K902023 - SEAL RITE PROCEDURE KIT(TM)

K902023 is the FDA 510(k) clearance for SEAL RITE PROCEDURE KIT(TM) by Pulpdent Corp.. It is a Class 2 Dental device (product code EBC) cleared through the Traditional 510(k) pathway after a 70-day FDA review.

K902023 · Pulpdent Corp. · Dental device
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Jul 1990
Decision
70d
Days
Class 2
Risk

K902023 is an FDA 510(k) clearance for the SEAL RITE PROCEDURE KIT(TM). Classified as Sealant, Pit And Fissure, And Conditioner (product code EBC), Class II - Special Controls.

Submitted by Pulpdent Corp. (Watertown, US). The FDA issued a Cleared decision on July 13, 1990 after a review of 70 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 Pulpdent Corp. devices

Submission Details

510(k) Number K902023 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 04, 1990
Decision Date July 13, 1990
Days to Decision 70 days
Submission Type Traditional
Review Panel Dental (DE)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
57d faster than avg
Panel avg: 127d · This submission: 70d
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 K902023.
PULPDENT SEAL RITE
K911287 · Pulpdent Corp. · Jun 1991
DEGUFILL (TM) WHIT-SEALANT
K902742 · Degussa AG · Sep 1990
SEAL RITE(TM)
K902022 · Pulpdent Corp. · Jul 1990
FLUROSHIELD(TM) VISIBLE LIGHT CURE PIT & FISSURE
K896341 · Dentsply Intl. · Apr 1990
MODIFIED PRISMA SHIELD PIT & FISSURE SEALANT
K874944 · Dentsply Intl. · Feb 1988
BISCO PIT AND FISSURE SEALANT
K874556 · Bisco, Inc. · Jan 1988