Cleared Traditional

K801237 - REIGNING CROWN-BRIDGE/POLYCARB. RESIN

K801237 is an FDA 510(k) clearance for REIGNING CROWN-BRIDGE/POLYCARB. RESIN, manufactured by Oki Shiks USA , Ltd.. The device is a Class 2 Dental device with product code EBF cleared through the Traditional 510(k) pathway after a 13-day FDA review.

K801237 · Oki Shiks USA , Ltd. · Dental device
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Jun 1980
Decision
13d
Days
Class 2
Risk

K801237 is an FDA 510(k) clearance for the REIGNING CROWN-BRIDGE/POLYCARB. RESIN. Classified as Material, Tooth Shade, Resin (product code EBF), Class II - Special Controls.

Submitted by Oki Shiks USA , Ltd. (Mchenry, US). The FDA issued a Cleared decision on June 9, 1980 after a review of 13 days - a notably fast clearance cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3690 - 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 Oki Shiks USA , Ltd. devices

FDA 510(k) Submission Details - K801237

510(k) Number K801237 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 27, 1980
Decision Date June 09, 1980
Days to Decision 13 days
Submission Type Traditional
Review Panel Dental (DE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
115d faster than avg
Panel avg: 128d · This submission: 13d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

EBF Device Classification - Class 2, Special Controls

Product Code EBF Material, Tooth Shade, Resin
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.3690
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 - EBF Material, Tooth Shade, Resin

All 821
Devices cleared under the same product code (EBF) and FDA review panel - the closest regulatory comparables to K801237.
SCI-PHARM PAINT-ON RESTORATIVE
K801797 · Scientific Pharmaceuticals, Inc. · Aug 1980
COMPOSITE RESTORATIVE, PASTE/PASTE TYPE
K801798 · Scientific Pharmaceuticals, Inc. · Aug 1980
KERR CORE COMPOSITE
K801529 · Sybron Corp. · Aug 1980
PRISMA-FILL
K801092 · Dentsply Intl. · May 1980
ADR COMPOSITE RESTORATIVE
K800439 · Scientific Pharmaceuticals, Inc. · Mar 1980
COMPOSITE RESTORATIVE, PASTE/TYPE
K792140 · Scientific Pharmaceuticals, Inc. · Nov 1979