Cleared Traditional

K801234 - REIGNING DENTURE MADE OF POLYCARB. RESIN

K801234 is an FDA 510(k) clearance for REIGNING DENTURE MADE OF POLYCARB. RESIN, manufactured by Oki Shiks USA , Ltd.. The device is a Class 2 Dental device with product code EBI cleared through the Traditional 510(k) pathway after a 13-day FDA review.

K801234 · Oki Shiks USA , Ltd. · Dental device
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Jun 1980
Decision
13d
Days
Class 2
Risk

K801234 is an FDA 510(k) clearance for the REIGNING DENTURE MADE OF POLYCARB. RESIN. Classified as Resin, Denture, Relining, Repairing, Rebasing (product code EBI), 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 872.3760 - 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 - K801234

510(k) Number K801234 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.

EBI Device Classification - Class 2, Special Controls

Product Code EBI Resin, Denture, Relining, Repairing, Rebasing
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.3760
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 - EBI Resin, Denture, Relining, Repairing, Rebasing

All 268
Devices cleared under the same product code (EBI) and FDA review panel - the closest regulatory comparables to K801234.
SOFTIC 49
K821230 · The Healthcare Group Laboratories, Inc. · May 1982
SELF-CURING HARD DENTURE LINER
K820673 · Coe Laboratories, Inc. · Apr 1982
SR-IVOCAP
K810687 · J. Aderer, Inc. · Apr 1981
MAXUM DENTURE RESIN
K800400 · Dentsply Intl. · Mar 1980
PERMA-CRYL 20
K792427 · Coe Laboratories, Inc. · Dec 1979
DENTURE BASE RESIN
K792042 · Dentsply Intl. · Nov 1979