Cleared Traditional

K844635 - HYDROSET ROOT CANAL SEALER

K844635 is an FDA 510(k) clearance for HYDROSET ROOT CANAL SEALER, manufactured by Lund Manufacturing Co.. The device is a Class 2 Dental device with product code KIF cleared through the Traditional 510(k) pathway after a 83-day FDA review.

K844635 · Lund Manufacturing Co. · Dental device
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Feb 1985
Decision
83d
Days
Class 2
Risk

K844635 is an FDA 510(k) clearance for the HYDROSET ROOT CANAL SEALER. Classified as Resin, Root Canal Filling (product code KIF), Class II - Special Controls.

Submitted by Lund Manufacturing Co. (Diamond Bar, US). The FDA issued a Cleared decision on February 19, 1985 after a review of 83 days - a notably fast clearance cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3820 - 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 Lund Manufacturing Co. devices

FDA 510(k) Submission Details - K844635

510(k) Number K844635 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 28, 1984
Decision Date February 19, 1985
Days to Decision 83 days
Submission Type Traditional
Review Panel Dental (DE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
45d faster than avg
Panel avg: 128d · This submission: 83d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KIF Device Classification - Class 2, Special Controls

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 139
Devices cleared under the same product code (KIF) and FDA review panel - the closest regulatory comparables to K844635.
ROOT CANAL SEALER, GROOSMANS' FORMULA BISMUTH
K896656 · Pulpdent Corp. · Feb 1990
ROOT CANAL SEALER, MODIFIED GROSSMANS' FORMULA
K896657 · Pulpdent Corp. · Feb 1990
ROOT CANAL FILLING RESIN
K854253 · Dentsply Intl. · Dec 1985
ROOT CANAL FILLING RESIN
K820284 · Dentsply Intl. · Mar 1982
LEE ENDOFILL, ROOT CANAL FILLING RESIN
K810923 · Lee Pharmaceuticals · Apr 1981
HYDRON ROOT CANAL FILLING MATERIAL
K801482 · National Patent Development Corp. · Jul 1980