Cleared Traditional

K830763 - FR ROOT CANAL FILLER

K830763 is an FDA 510(k) clearance for FR ROOT CANAL FILLER, manufactured by Shizai Corp.. The device is a Class 2 Dental device with product code KIF cleared through the Traditional 510(k) pathway after a 169-day FDA review.

K830763 · Shizai Corp. · Dental device
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Aug 1983
Decision
169d
Days
Class 2
Risk

K830763 is an FDA 510(k) clearance for the FR ROOT CANAL FILLER. Classified as Resin, Root Canal Filling (product code KIF), Class II - Special Controls.

Submitted by Shizai Corp. (Mchenry, US). The FDA issued a Cleared decision on August 26, 1983 after a review of 169 days - an extended review 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Dental review framework, consistent with the majority of Class II 510(k) submissions.

View all Shizai Corp. devices

FDA 510(k) Submission Details - K830763

510(k) Number K830763 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 10, 1983
Decision Date August 26, 1983
Days to Decision 169 days
Submission Type Traditional
Review Panel Dental (DE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
41d slower than avg
Panel avg: 128d · This submission: 169d
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 K830763.
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