Cleared Traditional

K896657 - ROOT CANAL SEALER

K896657 is the FDA 510(k) clearance for ROOT CANAL SEALER by Pulpdent Corp.. It is a Class 2 Dental device (product code KIF) cleared through the Traditional 510(k) pathway after a 82-day FDA review.

K896657 · Pulpdent Corp. · Dental device
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Feb 1990
Decision
82d
Days
Class 2
Risk

K896657 is an FDA 510(k) clearance for the ROOT CANAL SEALER, MODIFIED GROSSMANS' FORMULA. Classified as Resin, Root Canal Filling (product code KIF), Class II - Special Controls.

Submitted by Pulpdent Corp. (Watertown, US). The FDA issued a Cleared decision on February 14, 1990 after a review of 82 days - a notably fast clearance cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3820 - 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 K896657 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 24, 1989
Decision Date February 14, 1990
Days to Decision 82 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
45d faster than avg
Panel avg: 127d · This submission: 82d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code KIF Resin, Root Canal Filling
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.3820
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 - KIF Resin, Root Canal Filling

All 81
Devices cleared under the same product code (KIF) and FDA review panel - the closest regulatory comparables to K896657.
PULPDENT EDTA PREPARATIONS
K932791 · Pulpdent Corp. · Sep 1993
ROOT CANAL FILLING CEMENT
K914325 · Confi-Dental Products Co. · Mar 1992
ROOT CANAL SEALER, GROOSMANS' FORMULA BISMUTH
K896656 · Pulpdent Corp. · Feb 1990
ROOT CANAL FILLING RESIN
K854253 · Dentsply Intl. · Dec 1985
ROOT CANAL FILLING RESIN
K820284 · Dentsply Intl. · Mar 1982
HYDRON ROOT CANAL FILLING MATERIAL
K801482 · National Patent Development Corp. · Jul 1980