Cleared Traditional

K911287 - PULPDENT SEAL RITE

K911287 is the FDA 510(k) clearance for PULPDENT SEAL RITE by Pulpdent Corp.. It is a Class 2 Dental device (product code EBC) cleared through the Traditional 510(k) pathway after a 83-day FDA review.

K911287 · Pulpdent Corp. · Dental device
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Jun 1991
Decision
83d
Days
Class 2
Risk

K911287 is an FDA 510(k) clearance for the PULPDENT SEAL RITE. 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 June 10, 1991 after a review of 83 days - a notably fast clearance cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3765 - 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 K911287 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 19, 1991
Decision Date June 10, 1991
Days to Decision 83 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
44d faster than avg
Panel avg: 127d · This submission: 83d
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 K911287.
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
DEGUFILL (TM) WHIT-SEALANT
K902742 · Degussa AG · Sep 1990
SEAL RITE(TM)
K902022 · Pulpdent Corp. · Jul 1990
SEAL RITE PROCEDURE KIT(TM)
K902023 · Pulpdent Corp. · Jul 1990